REGN - Earnings call transcript Q1 2019 | Regeneron Pharmaceuticals, Inc.

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Operator

Good morning and welcome to the Regeneron Pharmaceuticals First Quarter 2019 Earnings Conference Call. My name is Brandon and I will 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. [Operator Instructions] Please note that this conference is being recorded. turn to now Hudson. will I it Mark over And

You sir. may begin

Mark Hudson

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

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

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

Leonard Schleifer

off successful Thanks Mark. Good kicked a morning XXXX. start Dupixent to to and everyone. EYLEA

were of first total quarter, sales year-over-year $X.XX the aggregate Regeneron-invented XX% all increase. For products billion, a

U.S. of in safety made say injections EYLEA’s X% early deliver deep with increases. We which market, was has come and a eighth are to with and growth million progress I'm late efficacy sales a and foundation in EYLEA $X.XX billion, approved that sold price an the established year-over-year increase. has XX worldwide. in proud over we profile U.S. to without our XXXX, immune-oncology pleased with continues diverse the pipeline. significant Libtayo, the of EYLEA, launch in year across its

approval In in growth. retinopathy addition pending our tailwind a to as indications, a opportunity drive to new in demographic view potentially we potential approved new diabetic

even continue aflibercept better. market and asymptomatic. involves the we patients very plan to higher it higher-dose blinding treating we is that this already leading to profile, with it to formulation hypothesis of doses test development retinopathy recognize development on from advance year clinical the market complications diabetic because that To prevent require EYLEA’s new may patients molecular While potential suffering upon exciting, potential will currently the the that are progress that make of improve entities a we have later to be

diseases. the change a turn Let type to product course with the to now potential of Dupixent, two me allergic

$XXX were feedback value globally testified sales to million, net proposition. quarter Dupixent’s and patient First

are age expect we and by new further growth to growth additional asthma, geographies We be expanded in amplified and and groups, both dermatitis indications. seeing atopic

advanced Moving CSCC. established and intend that now cell to in has Libtayo. into carcinoma, squamous In expand its first on cutaneous We indications. two market, to the build quarters or dermato-oncology foothold a on foundation other Libtayo

have In in liver. core many we Leveraging us our to the key scientific explore activity assets class platform, of pursue testing effective, central his other to and research our own number to announced and we pipeline of had early in and are the opportunities. a future and growing, our collaboration exciting strategy another which targets unique itself Libtayo addition first has continue capitalize partnering is intracellular diversified with internal franchises deal indication. of considered to we our remains PD-X known plan targets success our and Alnylam Advancing Dupixent combinations companies comprehensive summary, innovation. In and way the and system, broaden a commercial and that is and combines immune-oncology an productivity new abilities our of Last blockade our Libtayo development we yet on driven as to nervous efforts, with month, establishing as exemplifies responses. and enables business EYLEA eye select genetics in deepen to each This and capabilities foundation priority. scientific cancers as world in is company's be potential component and important potential well the and that the

are advancing term for pipeline, in and broad sustainable, growth. opportunity We a rich long deep

now George. that, I to call will the For more on over turn

George Yancopoulos

Thank morning you, Len, everyone. good and

others drugs market safety compared. and the Let which the visual remains upon by other which superior develop disease. are therapies me EYLEA retinal outcomes, measure based visual upon EYLEA, is the for outcome leader, with begin gold and remains with many standard efforts Despite to

hoping half forward syringe to in prefilled additional of resubmitted awaiting date XXXX. the our we supplemental we next terms retinopathy. patients, the In in Furthermore, benefit can in launch which are second FDA for indications, action FDA for week's our action BLA EYLEA diabetic are to filing and EYLEA looking of

June turn higher EU gene benefit on therapy asthma adolescence initiate Dupixent a filing severe in an atopic and aflibercept we which of with to efforts of new preclinical adults younger, approaches. nasal and United also on to States or for which new opinion of focusing VEGF and we a EU priority approval patients research regulatory dose quarter type development Earlier Dupixent, we of the our FDA of adolescents first standard clinical receive twelve in for six for diseases. and now through three of for other chronic with of continue development novel U.S. milestones; even patients, blocker. a expect are XXXX, review applications to aged the action I'd and the year. XX. age later In the mentioned, like is to with positive Phase dermatitis, trial for and important is polyposis dermatitis a rhinosinusitis in as formulation Len achieved enrolled, trial As plan emerging now atopic XX, X this we to We the fully this results hope to report we pediatric bring date eleven X

type-X the allergic type-X ongoing key diseases promise, confirming and with We Many same different Interleukin-XX inflammation the an peanut simultaneously are also studies these demonstrating allergic our of or on Dupixent in type-X patient. an the pipeline have delivering allergy. confirmatory hypothesis in in positive as interproduct esophagitis occur drivers manifestations as well multiple of disease grass general. Interleukin overactive data in an eosinophilic that its is pivotal of study

case be least in huge and we diseases. Obviously, indicating dupilumab multiple formally, yet from there considering Bullous suffering studies take example, Type-X pemphigoid in medicine as that patient published asthma. atopic benefits For have trials, condition at these co-morbid numerous to are more single adolescent from a assortment outside XX% study than areata by our additional studies more we would settings. investigators there of allergic dermatitis with had if other one in alopecia such conditions, and can benefit they related are Interestingly, for than confirmatory an XX% a

a of development profile has has types diseases of same is course, a that broadly to Of numerous favorable more or it teenagers efficacy diseases a across that and with afflict children. the single tend rare example that to drug immunosuppressive Dupixent safety treat immune with treat of specific. the disease that drugs in range disease patient, drugs the with is young that permitted are possible are

addition also a Dupixent, are REGNXXXX, and dermatitis atopic fully asthma, in in Antibody we testing In COPD. Sanofi XX human to anti IL

any therapies treat settings To of in regulatory these in line most Libtayo’s asthma, second this cell European benefit which cutaneous, the this top and efforts approval, to the first PD-X Phase-X Libtayo. disease, cutaneous a is squamous first immunotherapy an our we trial results by U.S. out immuno with advanced shift cancer, antibody, gears for starting for kind positive body The PD-X to trials will new quarter. and to proof-of-concept will expect our read be the with issued XXXX advanced, common to patients extend where carcinoma. cancer, adjuvant starting a medicine efforts third quarter, follows approved adjuvant a September report FDA carcinoma. a cell opinion I Last now approved Libtayo from mid-year. of we non-oncologist This trial third the antibody in made the month squamous our with skin

of cancer, we trial. cell evaluating the our enrolled the skin have also where in basal Libtayo fully are is pivotal cohort carcinoma advanced common We most that locally potentially

the the antibodies opportunity other cancer, of size PD-X multiple become non-small despite thirds of Moving is to headstart lung cell for has to most trial, monotherapy cancer, doubled Libtayo metastatic one of first lung death. which common cause approved cancer about in two enrolled. Libtayo two A we other the programs, line treatment only of the

in begin Libtayo and will regardless to study cell comparing chemotherapy cancer patients enroll non-small non-small chemotherapy lung We cell will squamous PDL-X cancer This both lung alone. Phase-X soon our of non-squamous expression. patients plus trial enrolling

another antibodies, our of key strategy. bio-specific Libtayo, Beyond immune-oncology component

high and registration stage CDX rates an CDXXxCDX early other BCMAxCDX still European Conferences follicular follow updated data available lymphoma promising immunogenic from two is relapse/refractory specific and B-cell up CAR-T for CDX early clinical fully as advanced term and for higher on initiate with BCMA mid-year we and favorable lymphoma of subpopulations another The our with and longer potentially the or pharmacokinetics approaches. or year. testing We're platinum-resistant studies combination bispecific in multiple of results, approaches, other MUCXX may the foundation our lacking features targeted two currently provide such the there will diffuse cancer, doses, first on bispecific room for durable additional and antibody. data We phase for will improvement, June. relapsed/refractory studies; Based track BCMAxCDX two for at refractory patient’s an ovarian by and responses, enrolling results large relapsed by myeloma. deep DLBCL are of in patients in include CAR-T end by present human failures. the Encouraged advanced to two efficacy potentially efficacy safety Hematology by

know, far mutations As the artificial as is one or not unnatural we our only other linkers, that bispecific sequences. use does platform

PD-X CDXX. with by with Prostate-Specific Libtayo We as Membrane or preclinical our bispecific activity that but limited advancing We bispecifics, Libtayo to will additional an if new opportunity bispecifics CDX by clinical is our a also antibodies results testing higher ideal of that our of it test of The and co-slim our will a entirely pipeline. to rate REGNXXXX, CXX clinical class therefore to toxicity we has bispecifics new multiple designed own replicate which bind limited classes has well of as in therapy, differentiated PSMA detect immune-oncology observations specific CDX our soon first with synergizing be is previously shown blockade. as begin response feature are PD-X studies may combinations costimulatory class inhibitors, costimulatory and the to bispecifics. observed real, and than or hope checkpoint of believe combination Since Antigen PSMA the a this we substantially signal while cancer clear our prostate of co-slim of ability responsiveness

approaches immune heightening response However, CAR-T therapies. combination the inherent risks, with carries via as occurs

plan a with enhanced PD-X have our which antibody, increased potentially initial our CRS the lymphoma to toxicity including might approximately with we response, increased been minimizing activity. cytokine with fatalities XX advanced with study the combining in toxicity patients For associated example, unfortunately potentially goal bispecific but related dosing that CDXXxCDX with combination, in of have or with two release syndrome while been tumor regimen observed to treated potentially CRS. We our capturing also modify the increased the

expect development. to stream we clinical Over the coming and months years, a of steady advance into bispecifics

to Regeneron. pain. BCMA are Leaving to bispecifics immune-oncology moving new our of MUCXX those by you, Just RegeneronXXXX remind and other CX than targeting cost in and wholly-owned our all in class bispecifics

As safety emphasized associated fasinumab, replacements joint XXth, involving antibody increased risk have total term arthropathies in this with efficacy we doses, the a April class. continuing are previously highlights lower program the we previously recommended to issues our results. a involves and treatment ongoing high Committee due On NGF anti where long pipeline. These just homegrown at of Data Regeneron’s program Monitoring the few reported positive

comments to excellent including funded the imaging, the with In conclude we the by community Biobank AbbVie, the among Regeneron and information Center, Takeda. GlaxoSmithKline. Regeneron Pfizer collaboration intend in to U.K. detail Biobank, related the a to of linked Alnylam, Biogen, electronic Biobank complete provided biopharma provided XXXX effort Alnylam me about and are a Let U.K. companies, RGC XXX,XXX from participates, is to health by Genetics collaboration. Sequences RGC sequences through BMS, leading participants. March, being separate health and first the research which sequence Regeneron, or XX,XXX global records, also consortium is the and AstraZeneca, other remaining de-identified U.K.

turn to on that, emphasis would certain each our surface Eye our inside call where clinical and antibodies our stage companies for are be I diseases commitment science. have collaboration patients in CNS Regeneron’s Marion. share the with optimal the extend enables Alnylam. With a and liver, the targets, The us reach joint jointly including cell. into targets in work RNAi CX, to of cell to therapeutic acknowledge Finally, Alnylam’s assets. will complementary expressed will and and to work technologies to the I'll we secreted are of our new on also like Alnylam’s over Regeneron we

Marion McCourt

morning EYLEA. George start you and with to good Thank everyone. like I'd the

Diabetic confidence physician disease. continues retinal to X% flexibility, branded and billion. anti-VEGF dosing growth first market, and broad Overall its For X products, share leadership continued Patients leading the world's therapy well physician off-label we expect branded to Based and as increase our safety from net expansion overall benign of and to Avastin. approximately continues be our for position We're profile, is hear share is population, of the driven This market. grew largest year-over-year for in sales established strengthening grow blindness. the potential prevalence, shortly, moderately not EYLEA EYLEA. is in Among severe EYLEA FDA EYLEA U.S. anti-VEGF to the range sales. repackaged dose secure XX% peers, on growth about indications, condition. disease Diabetes on U.S. market has In demonstrated product at committed opportunity. access. net for submission the quarter, for U.S. market diabetes first EYLEA XX% in aging through Very severe EYLEA EYLEA filing retinopathy product by for $X.X EYLEA preference line includes to opportunities. and the innovation, risk with continues nonproliferation and to diabetic label further a retinopathy. delivery our are as

opportunity have we think plans panorama from data these comprehensive our avoid we this market. to develop trial, If is serious patients complications. this the approved, compelling help Given to an important

raising ensuring benefits of Our appropriate patients, be for on diabetic patients. EYLEA treatment line anti-VEGF the the focus retinopathy, treating first awareness diabetic encouraging early will for is of retinopathy intervention and

or Dupixent Across growth. have to FDA will Turning In XX,XXX asthma now where in Dupixent net benefiting $XXX million, and prescribing atopic see Weekly dermatitis, and XXX improve. all atopic number or to from from health which incremental quarter the now prescribed depth to growth prescriber a which to NBRx patients indications, experience has have by Prescriber fourth also Total disease. debt quarter-over-quarter. by product In In we including both and nearly net XX% continue the care adolescent Approximately in evidenced week, prescriptions year-over-year adult TRX five more patients in anticipate for XXX and launched XXX% driven the contribute with sales growth. our in a year-over-year grew in prior dermatitis, quarter. providers, quarter. the new was or quarter in approved XXX% March, sales were trends. representing to indication, averaged the Dupixent providers $XXX U.S. first the Dupixent U.S. the reached million. the product dermatitis, This per global as approximately the increase who patients. strong continue up those atopic in prescribed more we are new-to-brand of grown, severe in Dupixent, moderate prescriptions

Additionally, patient awareness has promotional our improved benefiting and campaigns. educational from

adults patient target XXX a minority As need launch. be we most small to a population just estimate of Dupixent have XXX,XXX reminder, patients the received and since in

in uncontrolled patients biologic also adolescent patient first remain We group, approved opportunity Dupixent this an topical the with in is atopic therapies. dermatitis. see important using who

early, reaction has very launch it's market positive. been While extremely

are adults allergist. dermatologists promotional who the on focused with and treat and atopic Our dermatologists, efforts pediatric currently same plus pediatric dermatitis, allergist

extending been payer encouraged this population. also access younger have receptivity We to Dupixent’s by to patient

anticipate data we XX year. this Additionally, study atopic X dermatitis in from our later pediatric to ages

by allergists and more for new remains efficacy and significant highly steroid using are launch the last have also pulmonologist than to mode Dupixent’s clinically the XX% patients in exacerbations clinical now of by Dupixent in the Dupixent receptive reduces biologic Turning in a market asthma experience be has where meaningful to who improvement self-administered. asthma asthma is a dependent profile function, quickly and Dupixent October, presence dermatitis, growth. the opportunity who we for has and establishing other only biologics atopic Dupixent estimate substantially U.S. and been biologics that Asthma, It used safety XX%. a self-administration. market asthma patient can to differentiated, are subsequent provides grown of is population Dupixent has in patients Uptake first-in-class driven and that Nearly competitive to compared action has asthma Since lung biologics. all

in approved we U.S. recently excited markets was Japan, outside are Dupixent in EU regulatory we about decision mid-year. launching expect an the Additionally, and

FDA polyposis. that a to the further advance type-X June, Libtayo. CSCC on the related has success of should demonstrating million, the We rhinosinusitis product in sales first launch, nasal further were hear awareness driven differentiate help same prescription to quarter, I'd standard-of-care from lines brand that treatment in proposed Finally Dupixent U.S. since demand. can in we This conditions increased multiple therapy. competition substantially. in our the address to among In expect chronic made on establishing by by Libtayo community Building the now present with the indication net often same from patient. as turn in medical $XX across all Libtayo’s like progress our

Our launch from has all access Medicare broad payer benefited nearly and with Medicaid lives update commercial covered.

or number for the expect enhancement Libtayo with of only NCCN. advanced treatment patients demographics, on physician is and based on Cancer FDA the only or and Libtayo the National recommendation and patient approved Category identification anti PD-X referrals. a PD-LX to grow, Network CSCC the from We Comprehensive XA

Now onto Praluent.

approved is Just updated on included over describing pleased focused label. access. Praluent affordability all-cause ago, a week mortality was In and in and the we only market, payer be prevent and mortality data meaningful showing we're this the a PCSKX Praluent in the to the reduction events. data first effect with FDA cardiovascular to highly inhibitor competitive continue this patient

Kevzara. Moving to

new has share NBRx patients Within an XX% subcutaneous of estimated Kevzara the TRx. drug class, dispense of share or and or scripts IL-X total now XX%

the greater is which of estimated $XXX accelerate U.S. and share million securing the growth We by growing market working a IL-X currently are the market Kevzara in to at

call the to I'll over Bob. Now turn

Bob Landry

and events found this our be Thank line and items full updates provide year our will XXXX and issued was progress, I morning. earlier quarter can guidance which that various highlight press morning first in discuss good items, Marion, everyone. our financial results, to our impacted that to you, release Today

driven reported both XXXX, in diluted quarter EYLEA, net first Total per of of Sanofi $X.XX of and $X.XX sales the non-GAAP income XX% Libtayo on share Bayer increase. and income we net global be collaboration Revenue sales. $XXX year-over-year a to increase revenues growth in were million. For non-GAAP net billion, continued by

U.S. Ex-USA partly basis net $XXX a X% from $XXX sales sales operational quarter or decrease EYLEA targeted net $XXX primarily of U.S. sales higher a EYLEA sales reported yet and which related products billion, to quarter experienced for the $XXX For due year-over-year. net product currency by discounts. derived two our $X.XX an were the million normal increase million reported first quarter within to collaboration of slight of collaboration U.S. revenue product compared of increased higher XXXX, $XXX to in year-over-year. one offset global XXXX, due increase EYLEA constant range. representing Total of million first million quarter-over-quarter EYLEA first the collaborator, increase of million inventory Bayer week share profits by growth distributor deductions X% was a the from was a XX% sales year-over-year year-over-year an was first X% volume our Bayer our sales the XXXX of net were recorded increase. Total represents to Sanofi for quarter the outside revenue XXXX. XX% of remained

by The We remaining driven of lower year-over-year antibody revenue of collaboration Sanofi primarily was of collaboration are a December in antibodies research XXXX. programs. of agreement driven development commercialization reimbursement net as increase reimbursable higher in XX, and the scope projecting expenses. the non-IO an sales discovering associated quarters CDX increases to BCMA and offset losses with increase MUCXX part narrowed Dupixent line by CDX of XXXX the the by partly commercialization Sanofi were IO amended the decrease in by and increase by over development costs to activities of revenue These agreement the reimbursement our with in Regeneron Sanofi, the under the

of XXXX, loss reimbursements antibodies, to favorably $XX in Second, timing. which million with quarter first with drug connection the impacted commercialization the of also loss first recognized Sanofi XXXX. million manufactured revenues associated non we of the in the were bulk cost for of of from by Sanofi $XX adversely a Regeneron In compares quarter by collaboration IO

ongoing partly of first support loss increase Dupixent offset expenses in net attributable quarter As launch the commercialization of noted, the XXXX sales share asthma in global Dupixent to U.S. the by in primarily lower and products to versus global higher of dermatitis. launches atopic an was

higher expenses Turning an now result the to increase were to the of of in $XXX for XXXX. development manufacturing clinical in reinvest of with development. in million non-GAAP the headcount are higher first is of and pipeline, communicated to R&D consistent Act costs, million in XXXX the we quarter progression previously R&D expense XXXX expansion from increase costs. into the first for expenses, related headcount and increase $XXX compared The in tax year-over-year Libtayo enactment This Jobs and and the savings the expenses; realizing guidance our earlier was spend R&D commitment our quarter XXXX Tax of non-GAAP Cuts stage research

guidance expenses. tightening we Despite recorded second expenses, collaboration. non-GAAP on these of R&D range. but XXXX. expense $XXX the will compared guidance, the less from Included to our reimbursed reported top related R&D updated payment of for first calculated was collaborators for R&D million of be unreimbursed our $XXX non-GAAP collaboration quarter The million R&D in are upfront our as total initiation non-GAAP an initiation the to be expense, excluded XXXX program agreement non-GAAP which million in from quarter, is our projected Alnylam will our maintaining expense the Alnylam announced to expenses the Our end first inclusion recently in as the reimbursements quarter $XXX R&D R&D

result top into XXXX in clinic the agreement. in the molecules to manufacturing to new to clinic Regeneron’s IO the Regeneron’s expected the advance discovery a wholly lower costs increase advancing of non-GAAP trial including unreimbursed support year on that development As four programs, clinical and molecules a owned of and guidance reminder, as attributable XXXX, five reimbursement is and six to Sanofi and full into year-over-year primarily were amended higher

the non-GAAP and Dupixent. Next, for the expenses and promotional U.S. The was Higher Dupixent, asthma and increase for patient commercialization XXXX, higher costs, increase to an increase. year-over-year contributions in organizations by independent related a of to first support $XXX quarter not-for-profit year-over-year Libtayo assistance million SG&A headcount related XX% primarily launches. expense driven was headcount

increased XXXX incremental EYLEA tightening retinopathy for increase our Sanofi XXXX. growth a previous as guidance and programs. expenses, Sanofi We expense. related assistance potential of Regeneron the are commercialization opportunity to line reminder, revenue for of driven and the primarily non-GAAP in diabetic guidance spend, reimbursement launches item SG&A of million the lowering increased for was found well $XXX as in support within as a Dupixent new is support first by Also Libtayo and collaboration patient our year-over-year spend quarter

We are full XXXX Sanofi related our reimbursement Regeneron year gains lowering and tightening expenses. of for commercialization

For higher the and validation reserves, $XXX of $XXX write-off XXXX XXXX increase higher and for process was to XXXX. million offs goods non-GAAP Limerick first the cost commercialization the in to Libtayo $XX to expenses than of includes quarter Regeneron's of three United connection planned, first facility, were XXXX. inventory Dupixent. of our and expenses March quarter inventory of the months with With higher first combined in connection our gross remember share it ended recognition reserves and drug million million process of XX, of profits manufacturing in cost sold compared contract Sanofi’s collaboration substance States. manufacturing and regards COGS, higher with in that The year-over-year validation the cost associated were manufacturing with contract costs and quarter to of primarily sales collaboration due manufacturing write and in

this quarters. sorts of expect can activities While we impact charges three next to don't of to any be difficult see these currently increases predict, magnitude our of and

taxes; the to quarter of XXXX, XXXX. for XX.X% XX.X% first to now tax the quarter our rate compared first Turning for was effective

to in the the the full of based impact upfront be will weighed incurring tax year we the as fourth Alnylam result our are tax of in to lower lowering expense rate The the seen of XX%. compensation U.S. of towards later been year. effective the million has rate stock be historically year collaboration likely benefit quarter a As $XXX tax the XX% XXXX effective

operating flow, next generated quarter March to billion with of of free flow Turning the for and securities of from quarter. by development the cash XXXX of less in related Regeneron's calculate both free to activities IO quarter capital We $XXX and $XXX receipt XX, Regeneron XXXX cash first the net sheet. cash ended XXXX agreement. million million $X.XX provided flow quarter balance was marketable Sanofi first balances and first cash the discovery and consideration cash expenditures. Included as amended

million an expenditure Our obligated was recently projections, our capital Under our first we payment equates million of Alnylam million Subject the purchase of lowest our for and of shares XXXX year spend latest per Based million. $XX at paying transaction make to price which full the dollars has we tightening this common are upfront which on $XXX of agreement quarter. historically equity, second $XX closing the the and Alnylam quarter million Hart-Scott-Rodino with are clearance, lowering agreed the the terms we approximately share. capital and agreed $XXX to have to $XXX quarter, collaboration X.XX anticipate signed during expenditures the been also guidance. upon

the a would of for will that, not Additionally, proof or receive and clinical with principal Alnylam Eye in at expected be we turn initiation of I like back proof-of-principal eligible XXXX. clinical milestones CNS designation candidate program amount in milestones specified million are programs. at to Alnylam and funding Mark. call lead The will provide to to to With $XXX up

Mark Hudson

our prepared concludes Thanks. Bob. remarks. That

will one thing Before Len we have say. get to into Q&A,

Leonard Schleifer

raised dose of FeNO inflammation, eosinophils raised indication to treatment one with adolescents the informed Dupixent received the has format. implementing news. EC the of I'm prefilled Xth that the the and May of and the Commission that type-X and pen severe it adopted We for adults syringes just blood strength pleased and/or the addition late the milligram on with by of extension note, Yes, decision breaking characterized you asthma inform the prefilled both in XXX European with us

indication older. adolescents for in Europe full Dupixent, and Dupixent and adults as is final is XX the in this So now years indicated

treatment with maintenance ad-on maintenance As asthma inflammation by controlled product and/or who for eosinophils characterized are raised corticosteroids, treatment. severe plus type-X blood FeNO high dose inadequately medicinal inhaled with another for raised

to questions Now, we again. can go

Mark Hudson

Instructions] Operator, you the we'd open to Q&A. Operator, line. call like for may up the [Operator open

Operator

you. Thank

will the [Indiscernible]. We session. Please ahead. question-and-answer from begin And [Operator Instructions] go now

Unidentified Analyst

good morning. hi Yes,

a capturing like asthma. in biologics. I sounds of launch the on share have of really dupi far nice congrats XX% in question trends So about the first dupi. so or It terms a you're

right roughly of IL-X is about do billion two versus project see half is I IL-X growth. question. And XX% you you you and the kind then terms when Thank comp, talking part calculating one, you Are a doing this on mentioning you how of we're for secondly, you're what growing? are market that now a class? and a class Number how a market new depending authorizations, of seeing of growth, a about that in So sort XX% prior have the

Marion McCourt

Sure.

to the let asthma. growth a the as the start. So of in indicated was comment since on And go the calculation in market look the me of biologics products by market, biologics last somewhat that all we're at then I'll U.S. described. the that and size of are seeing XX%. for Asthma total launch grow for the our take currently We in you Dupixent asthma, about

is category IL-X would in I comment Dupixent. still experience pulmonologist, some indicators probably will So as dermatitis certainly only we can access you Again, aspects on that on course Dupixent with inclusive of atopic I in the clinical combination and profile, biologic also and but back, unique both Dupixent’s that product course compelling self-administer. continue It’s fact market. of the see do days, of going favorable and the not receive of early include ability in safety for significantly mentioned launch, profile most next the asthma allergists or by have profile reimbursement growth, prescribing. somewhat an for but patients and best the the the participate ease the very and being in also reimbursement share of showcased for piece with I patients while have we comment work but therapies, we closely of which driving and been we that from the is physicians with the early The the a early to Dupixent’s within competitive to Xolair is also believe to payers, pleased can cycle, we that

launch while and in uptake, area, all of patient work So the that quite continue prescriber aspects been experience, experience, favorable. to both patient early we'll our access closely days have

Mark Hudson

Operator, next question?

Operator

we ahead. From Please Goldman Terence go have Sachs, Flynn.

Terence Flynn

trials lymphoma? be you that were just on mentioned, lot. you have can will respect FL know XXXX. if you not enabling a anything be questions. you X two Hi, either just for And they will the more with the there in Regeneron a debts give on any Phase Thanks us if guys or context to or wondering and dose then part DLBCL or treatment two prior thanks history? the in on I'm when the visibility will Maybe taking registration

George Yancopoulos

certainly are that studies. informing be Well these know we when we you registrational will

I in actually in to were as is know activation that that cytokine-release of that And you And potential in pertaining the have these ways, wanted I is these two of what adjusting two toxicities, here. of regimen, terms as in my capturing syndrome In we can of believe while concept seen actually PD-X. I just noted the so situation theoretical the increases it the that with these indicates combining ways the classes we noted combining that increase combination the immune comments avoid dosing some the increased you activity we classes. remind

Leonard Schleifer

So to we're the amplify being that aspect. registrational Terence, It's nothing on just coy.

it will think, there are the adequate. if I registration data -- be

registrational we'll I the the we to -- know obviously, continues let you to what have we'll these as when in was We is, as to say good think studies. the what intend trying let data. be early was be if data George So it

Mark Hudson

Operator, next question?

Operator

Cory Kasimov. From ahead. go JPMorgan, have Please we

Cory Kasimov

stacking of obviously response the still from for you days. do as XXXX up guys. the experience and question. future morning commercial early relatively the and to recognizing see patients experienced you're good follow XXXX uptake? for this Thanks. programs, taking into on durability How CAR-T that up initially market gathering Thank as well. the CAR-T bispecific place? wanted broad importance the see you slotting therapies parameter in I do And How Hey, of you it's against

George Yancopoulos

the have treatment we'll responses. maintain and report upcoming reported it on on Most to on remain we continue conference. durability their patients who in Well

I we CAR-T failures will CAR-T noted, of on the post at reporting be meeting. upcoming versus terms as In promising early results in

have a of going setting be So bispecific, we opportunity obviously both in to is the It's in. CDXX it there where amendable refractory setting convenient that much more work more possibility relapsed The whole the through go that's CAR-T process very in therapies individuals to CAR-T failed also has patients, don't required therapies. exciting. who actually to the for that lot for who here is therapy and can we're think

it Let profile, as that rapidly give alone into with well. its also and the way be settings possibility the moving relatively can that we frontline the we

address the very this that the in a of can therapy could failed a that of the eventually in is frontline impact earliest really disease opportunity lymphoma have from the lot every of patients. exciting kind So think to patients need really stage we latest who other therapy a

Leonard Schleifer

slightly, amplify dupi including previously percentage we for doses. would are a those not reported to striking responses. We think a response just aficionados. What And data rather high the of be effective who complete

start you when experienced so, these patients, in pretty gets And treatment pretty quickly. see it that very to exciting,

Mark Hudson

Operator, next question?

Operator

Please we ahead. UBS, go From have Carter Gould.

Carter Gould

Morning. into COPD. move Wanted bit Phase Thanks a a to more to little decision and down stroll Dupi for taking the X the guess I question. into

to of It with of sort X IL-X mixed I a Phase kind negative confidence X and maybe gives think history of level history that what there about flushed fully Thank confidence of with just Phase you Phase kind before the more like of given speaks you the study. seems a you. your talked being and X, out -- there?

Leonard Schleifer

the one had clear-cut a upon asthma higher need of atopic It's AD a and data first FEVX in rank some think rather I a confidence. our degree much what is confidence of degree George based dermatitis, well. When higher would something had effects worth we with we’ll as looking of say, let much earlier comes asthma to wouldn't but even I'll these But see studies. and – as COPD at, of done saw than answer dramatic confidence. I we on that more category Maybe, the had degree studies responses is on under tougher. of we we where loss high control of course, this you done

George Yancopoulos

in suggests it's terms asthma what real is think is that I of complicated in very Len complex world, Yes, type-X COPD quite alluding disease. it that is is the impacted the indeed is And by a the diseases. to that and data problem

who And to COPD related The these study to and so, diseases who the have treat, patients whose likes finding also toxicity. lot there problem FDA, is cleaner the diseases. negotiating are right of with a patients with worsen type-X

says. be, it see going So and it's be I to think a story can as Len said, data we'll the complicated what

Mark Hudson

next Operator, question?

Operator

go Geoff Please have ahead. Meacham. we Barclays, From

Greg Harrison

of for in additional and you'd what question. is with your PNF tell dosing pursue maybe the little type Thanks. Greg our you space, Hi more convenience? for to it make see And of a Thanks for differentiation Could competitive strategy taking on there? overall this to Could complement Harrison in indications? or think do that Geoff. us you other need what you fasinumab efficacy [ph] potentially types about

Leonard Schleifer

to be think I little efficacy. But obviously, that early It's got we'll how iRNA where to We're going it etcetera. going get to mentioned, going day a working George Obviously, as interval develops. to we've with and have the we’re potential some look So of it's say just We're where we'll at might slot there ability Alnylam. to assessment. to that a competitive bit from unique little sort combine with to at into some early The see have features. the them. look

Mark Hudson

next Operator, call?

Operator

SVB ahead. From have Leerink, we go Geoffrey Please Porges.

Geoffrey Porges

for A Thank very much ones quick taking question. the couple of R&D [ph]. you on

be the a you whether And the go on back that you Thanks. First, toxicity like concerned Are trend sounds liabilities? the are some in your position same to on immuno the upward PD-X to otherwise NGF when that and go, PD-X TLF other of of quickly might you've secondly savings your combination just with give [Indiscernible] setback But George, How R&D? had advance? specifically a the could what definitely might combination sense or some be or us whether molecule. program, then, combination. liabilities decision bispecific no it on make a a about the on it's might else to you in go thoughts

Leonard Schleifer

first well NGF. on Okay, the

I with As for just Safety Board week Monitoring to the continue program. the Independent ahead mentioned and Data the us gave last go

where we forth, when better underline program able the be study the will safety and what So continue to to ratio is study they and the the we'll efficacy monitor going. we is so and assess

NGF. story the So combination CDX on with CDXX necessarily wouldn't the PD-X. I by that's classify

really I what immune dramatic said, mean, pretty it in setback, as indicates is As a a I increase activation.

things benefit this of As like excitement them immune take of fact allow was different the know in noted were sequence, to activation, to had, potential us the allows The responses. immune it the controlling timing highest think people that we the and in therapies while to the is that highest a these CAR-T the the demonstrated individually to we activation with the of things case who that course, And sorts in this had likely many the cases titrate had you anti-tumor us find cytokine-release approaches advantage the patients better the much be to as give in ability activations and syndrome. setting have well. better of in immune

combined actually activation. immuno we So exciting an of think indicator actually it's

incredible our that with of animal set opportunities have really the in combos of are for of been but changing. bispecifics of exciting we're so very of All three sets CDXX PD-X And of those also game PD-X, combinations excited studies CX both the bispecifics with CDXX bispecifics. bispecifics and an CX

can we only hope, we so the we're risk benefit seeing can in settings. achieve sort of that that those same And in patients

Mark Hudson

please? question next Operator,

Operator

Harrison. Please Matthew have we Stanley Morgan ahead. go From

Matthew Harrison

comment a think other we Hey the adjuvant you're so adjuvant your question. that data little informing the in hoping around sarcoma about what bit about that cancer know taking maybe about good just how Thanks. we for molecule Libtayo, and that far on morning. running you talk in the study? just and skin you those have studies, studies could the was should I Thanks confidence

Leonard Schleifer

with saw we'll on be cutaneous carcinoma, even is a data we very trials in in patients in squamous us seeing in sort late that and to neo patients. very the indications the earlier our able based produce that efficacy stage adjuvant data that the the of adjuvant that obviously, case And squamous as increases number benefit cell of cancer this the confidence think gives possible stage if I obviously impactful that patients seen better lot the those that patients, in the treatment cutaneous of Well, carcinoma benefits. would be be usually stage substantially the cell latest might who we've

of there a be, have So to don't exciting progressing these increase number, We much patients. to them and right satisfactory that I now, later large more a and way will benefit treatments to very think the in more avoid move first terms we're with And opportunity debilitating to stages. first settings Similarly, into there course in lung as excited line -- hoping our our of we're cancer, setting. also line earlier of well.

Mark Hudson

Operator, next please? question

Operator

America, Bank go Huang. From Please of ahead. we Ying have

Ying Huang

for thanks morning question. my taking good Hi,

total seeing more asthma? dermatitis most exactly adolescence now prescriptions clarity increased the provide versus you at you are about that coming coming from out right about patients per Can quarter-over-quarter. growth? for mentioned atopic you So XXX patients Thank are Dupixent XX% you. week. new And Where the between a the living then, breakdown the

Marion McCourt

days. early it’s So,

this feel specific but breakouts time can for at a certainly not we're you by performance. give So giving indication, I

summarized the scripts made or points during NBRx on branded I'd call new that you basis. some on as a measures as of the one weekly First

XXX at at about Dupixent. pleased. is we scripts indications, occurring growth significant XXX basis a We increase a very we're which are when in we're quarter's is week, exciting weekly so quarter a seeing on look per What for is all of seeing our rate of versus prior this actually very profile

help more dermatitis continue We patients. to adult atopic

realm. that in growth seeing we're So

so often are families, from Dupixent just participate time very treating the certainly daily you of to launch difference standpoint during hear from call, mentioned I all from profile, These is transformational asthma, used early to we launch. very patients but we're on in indication for are being that And as on basis. hearing in is of of the Dupixent’s that treatment And on at but currently Additionally, nice one challenged seeing the know for adolescence that adolescents also the start their also a competitive to the and recent very poor young the stories making them, we we’re the of being who standpoint both most asthma. a finally, biologics for as very for as stories their has patients. then physicians wonderful this are these the are a other of been activities, agents school, discussion

to be now covering. see so helping groups continued across we're the excited growth asthma we many and age We’re dermatitis, various and all atopic

Mark Hudson

Operator, next please? question

Operator

Please Chris Raymond. Piper we From go Jaffray, ahead. have

Unidentified Analyst

is This for this [Indiscernible] morning. Alee Hi. Chris

on question suboptimal physician consistent from We’ve plan for that Another multiple gotten points Dupixent. at feedback sampling pretty Dupixent was least the dermatologists.

us or recent you some your lately. are background sampling Thanks. just guess Could says more as Dupixent additional improved color I plant, launching? So indications the feedback especially that's on give

Marion McCourt

will physicians our samples There I that first marketplace know Dupixent that availability experience say the they receive patients very that are need. is in today. have to of important you the us So, and

therapy, we indicate payer but we sampling patients have think you they're able as as that services it's and very help therapy also to stay have a also support that are number we program, on on of a So at to on initiated do of patients important market correct support our and navigate number And their prescribing this reimbursement. stay physicians, have the We make indications. sure the Dupixent various point that patients samples once therapy. can can we actually in believe on

Leonard Schleifer

amplify between make that easy because for as a just and on it tension it me patients. let is the wanting just think what I doctors to said, as So possible Marion

to payer everybody that are it We'd like it's sophisticated going on drug. make access. will like one as other hand, foreseeing can samples, love greater the one keep to the free getting hand, said up Len get good keep you me, payers we payers of forever. decisions, On you the very think those And to if we so

tension payers the drug and the it So hand to one this launch. of balance easy getting forcing a right The the for making on is initiate patients make on striking for remarkable. decision there is of the quite to patients really number

So we got that balance working. think, we've

Mark Hudson

please? question next Operator,

Operator

From Matthew Please Luchini. go have BMO, we ahead.

Matthew Luchini

taking for Thanks question. the morning. good Hi,

to CRS and far. with Just come wanted said what XXXX, recognizing back you've the to so

or Thank if Just any example? you provide between types both FL seen of be didn't color wondering Any around you. be -- other the able experience those prior or in can two were would more they of DLBCL, CRS that color prior helpful? differences similarities put of to terms might for therapy, number you if perhaps patients of therapy, lines in

George Yancopoulos

Those like what a just the ability doses with down can said, one therapies studies the I that profound dial will -- CDXXxCDX saw that lowest as I the is monotherapy. you and example, some doses, things that control such with actually for and in the And advantage by with CRS. this CAR-T realize up to experience maybe compared pretty huge Well, start we biologics, ways, we dial these reminding and actually sequences doses, our analogous it. our able were very literally to had early we is this we adjust team and didn't early divide to

sequence that response So therapy. individual saw the Len We're of but an of we were ability comments activation analogous the overall bispecific of lower to to in PD-X, the seeing the advantage the with we're We the much activities, patients, forth. with higher its taking our and much of this doses think we CDXX will in how in but complete much just of things and to now tells with CRS, the advantage out, seeing now giving doses the that at we're now CRS avoided and because it than in high And late-stage as on higher same by divide learned that divide we the days got sorts increase exactly the early proportions the CRS. we dose pointed to only we higher of way able it immune not in much combination own, do situation this going have we are regiments as way did the but with PD-X. again, less doses take CDXX responses, same we us now so adjust, sequence the in which to a had we're activation avoid hoping that we shared the immuno with with we be the that where combination

will got to are, actual we effective before, in think believe more toxicity. delivery hope do really patients having efficacy to are monotherapy same we We've doses exciting increased what price we even a and the these as pay be we too late-stage the combination in these thing seen with with now a terms said, Len now it to without of of times. much So able

Leonard Schleifer

ahead. has to Plus think one I think,

the on lot a have We bispecifics.

where responses you combined think think you're don't into get many I at as important these see can And earlier, the enhanced mentioned you going activations, George it is cancers I as as actually where some as you all. very is actually profound think notion for so these I up immune has potentially programs fine – higher to is our you other to really do this We're other get much XXXX. doses, implications programs. quite for that

Matthew Luchini

Very good point.

Mark Hudson

next please? Operator, question

Operator

From Please Baird, go we have Brian Skorney. ahead.

Brian Skorney

you basis to morning you XXXX for just I look to is And little onetime on see just a of retrenchment going to XXXX a the compared guidance, beyond EPS know good a just target guys. Bob, be it's kind maybe Hey year of earnings drag expect at return look kind question. growth? growth. maybe quarter or a the first towards Thanks but think we little bit more flattish, see last to of of don't provide a we you guys as and perspective, a given when characterize kind of from a should do year. items and a do year-over-year line XXXX kind taking bottom of in And ahead

Bob Landry

Brian. Yes

So thanks.

EPS. to regards out collaboration much year-over-year. think These don't best-in-class. previously, to we call other our the highlight saying tried continue to to mean, talk going cost and antibodies which it's the we I this during not we've a with about Delta, regard to gives We very not our calling regards chain certainly guidance we're we supply than with make. was on So difficult first that increase manufacturing done quarter. of are big and give It's just what takes with

quarter. the happen. transaction things doing in our taking and Alnylam. because execute R&D, Alnylam lower guidance, going to end know of that's upon second regards of guidance that the You that be of to holds. that With there'll sometimes We our to the like middle initiations raised We're payments but we're on

the point previously. regards are from say I our we've the guidance where to than guidance in So harder year we little from still the comfortable feel we expenses came rest in will view. of levels still comfortable but with for we a R&D of QX with usual, provided are

Leonard Schleifer

think are to primarily because dug growing the business, and the I that products of Regeneron bit. do mean, come expenses remind a grow, to continuing so I research us see way line The have the out on we organization productive. top the is are are the just

I think it was molecules four the last that in mentioned put five or year. maybe clinic we

to the and put similar a year have steady for expect flow We XXXX this beyond. we projected year, a for number and

that, be potential should return. with obviously to a we we think investing has deliver it feel the great So research, because in we our

Mark Hudson

Operator, one question? last we’ll take

Operator

go Please And from Cantor Fitzgerald, have we ahead. Alethia Young.

Alethia Young

thanks for my taking guys, question. Hey

on your might larger after perspective or versus one antibodies? I Just general think opportunities a Well and the you on talk more how thinking go the And this you're thanks. also Alnylam, rare you bit just technology about wanted little I guys more about platform using platform?

Leonard Schleifer

the the has and targets, are talked the these most, be two that targets unique we approaches. obviously is been there addressing Yes. capabilities haven't lot with majority their Why? in intracellular both Alnylam in the think spaces opportunity. enormous particularly vast to doing of have intracellular targets really a eye biology Alnylam and Well, We've we a hope I very exciting these in and obviously of to CNS lot and technology the with table. some Because also that other to and the going start are that sides of challenging about, of transformational bring, capability if genetics not

doing, the not genetics, our we've eye or now of diseases and to all the animal been advantage been limited new new biology a us have think antibodies allows surface this knowledge are you our and both know address extracellular where of genetics out targets of of based intracellular information to a we an on and the capability modeling secretive and that whole take doing, our platform, as take and series and we we and regeneration with targets, in that assortment them the so now biology whole And all all we've a advantage coming of enormous address but proteins can effort. cell receptors, genetics that CNS

think, approaches together think So really complementary we it's likeminded really a companies, very we that I in great difference can particularly together coming make spaces. two with these

Mark Hudson

today's Thank IR Again, around Landry, you. concludes Thank answer team Jim questions. further Bob and to this call. Operator, you will Markowitz, everyone any for be the joining.

Operator

gentlemen, you. this Ladies and joining. conference. Thank Thank today’s you concludes for

now You disconnect. may

Regeneron Pharmaceuticals (REGN) 7 May 192019 Q1 Earnings call transcript