BIIB - Earnings call transcript Q4 2020

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

Operator

Good morning. My name is Jake, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Fourth Quarter and Full Year Earnings Call and Financial Update. [Operator Instructions] Thank you. I would now like to turn the conference over to Mr. Relations. Investor Director, Hencke, Mike Mr. Hencke, you conference. begin your may

Mike Hencke

Thank fourth quarter Good morning, to Biogen's and welcome XXXX you, Jake. earnings call.

Before to release everyone section including today. non-GAAP we to go GAAP of measures will discuss financial financial to encourage begin, and to the our a GAAP of find related and biogen.com earnings the financial tables, measures the we I reconciliation Investors that

beliefs. risks additional Dr. detail. materially. our Research are current Sandrock, in I our that to statements reconciliation of On non-GAAP the and Our results. now X, will reflect subject website Development; for our Tables joined These will call and statements, forward-looking our of on internally. are that are you SEC encourage I results how certain We’ve to risk actual consult be this filings to expectations factors our based includes the discussed McDonnell. and X business discussions which ongoing to our and financials non-GAAP turn uncertainties the GAAP GAAP believe X out on may to a and and financial and related Mike our I Al represent slides and like CFO, EVP, Michel Officer, the today's We Chief we we Executive financial follow by our would the over provided Table better call, call. making also in manage I posted Vounatsos; results business point economics to am differ Michel.

Michel Vounatsos

years, also to role. time, the excellent the the thanking promotion. well-deserved and start us. congratulation Joe for into Hencke, morning, for contribution have I same his and thank XX his everyone, stepping would by joining during delighted for Biogen past to I’m Mike to Good Mara you At like

last U.S in announced review week, for July extended the to has the the timeline we’ve FDA X. As aducanumab

continue and the our to our review support committed to as it its We completes believe application FDA are aducanumab clinical We data. the we of results stand working with approval. behind

XXXX year. for a society due industry. at COVID-XX Let Biogen to for also what And and was I of uncertainties of year delivered. our team me the now both am proud the review large

billion year year-over-year, X% increase a XXXX, as non-GAAP the Biogen entry. we experiencing For representing the to of full generated $XX.XX TECFIDERA erosion a revenue $XX.X Full slight the the XXXX in generic are revenue, share, a year full year decrease U.S due XXXX. earnings were impact in versus of

our against strategic review me let progress our Now priorities.

of royalties were versus First, full the X% year decrease prior a $X.X year. revenues including OCREVUS billion, MS

number and U.S despite number the TECFIDERA these the our Excluding believe the ability in overall, relatively year and of We improvement well, trends one XXXX. competition, U.S. we TECFIDERA of prescriptions execute terms to global were full MS product results revenue our COVID-XX. Despite stable leadership two QX challenges for in has VUMERITY, which the for U.S., see become new product versus during remained in COVID-XX, a and MS pleased to of the maintain erosion launching the and strong in revenue both new the the increased in demonstrate

full generated year versus SPINRAZA global stable versus was QX of X% a $X.X prior QX. the Second, decrease year. global revenues revenues billion,

SPINRAZA dose, the treatment remain been that continued There as a enhance other potential growth are generating to While will data the in unanswered by of exacerbated inform to believe as And foundation committed on competition the the remain are important options. the exploring to evaluating a to SPINRAZA patients treatment higher RESPOND SMA. to which of response initiation patients recent offset of SPINRAZA outside for This SPINRAZA. the with DEVOTE was in U.S., that sub-optimal committed study study COVID-XX, is facing well the of has the further a approved outcomes We the in increased this testing we relevant therapy. remain further by treatment clinical questions with care includes choices. gene We impact U.S.

Third, COVID-XX help We million savings of performance of innovation. despite continued with €X.X XXXX, growth billion X% generated for and the which in impact, that represents $XXX access create which Systems XXXX, solid estimate new revenues Health European biosimilar approximately biosimilars delivered year-over-year. the to headroom use of for should Care expand

business we a of made remain U.S., where, R&D EU towards referencing important savings. billion We potential LUCENTIS ready $XXX SBXX, growth if for was in are the with positive aducanumab future expected progress biosimilars to expansion to over U.S for filing XXXX next the Fourth, submitted filing our in year in We geographic when aducanumab also and it over and generate years in biosimilars for launch the approved. the Japan. year very regulatory U.S., organization. is Last and the X

the pathology approval start aducanumab of formulary are and Our be of the believe MRI ability beta, patients the approved. that teams the to capacity, have sites processes. ready should evaluated amyloid confirm are specialists, availability treating there several to XXX capacity in infusion We U.S

Beyond programs year aducanumab, and Phase Parkinson's we depression, in last biosimilars, including addressed MS, or ALS, disease, X. advanced XX across for new clinical

potential first-in-class new collaboration serious Parkinson's and disorders, depression for Denali, such disease. entered we access with Importantly, therapies Sage strategic as providing and neurological to

depression significant provide year in stage in expect adds in XXXX, allocate we both us X to across flow portfolio. programs data cash X. Sage existing and Phase including depressive stage Biogen's late in eight readouts readouts multiple with continues Fifth, our programs late four to flexibility mid synergies Overall critical asset capital. generation important offer and would collaboration postpartum through depression disorders expected Our Phase with with major diversification this to

and year billion progress we return franchise a biosimilars, to strategy. maintained and SMA for significant allocated In building capital Despite shareholders XXXX, MS, COVID-XX global During $X.X we and TECFIDERA productive leadership we business have the businesses in of challenges from core a very XXXX portfolio. made for and our company we multi $X generics, executed in our pipeline. across roughly approximately to the as development have our have enhance was billion towards summary,

company be reset we top company year the grow we we a for will the lines, with both believe can but XXXX bottom Mike believe long-term. As the financially and over outline our on will the guidance,

As maximizing shareholders, I committed turn now we more update Al returns for we demonstrated to are past, will patients. on R&D. have we call to to innovative over our detailed progress to our in aim in as for a the bring therapies recent the

Alfred Sandrock

and life Michel, changing everyone. innovative, their in for good to like potentially therapies thanking my and begin for I'd Thank developing you, to need. patients discovering R&D by colleagues morning, dedication in

of across a Biogen. for We a building in progress significant was of Phase year result their therapeutic As of multi XXXX franchise XX work, number milestones key X with made a a filed areas. now hard or either programs toward portfolio

we patients the before a our pathology at early to may the slow Alzheimer's whether may aware designed around inevitable even proud pathophysiology X-XX benefit in are more treat disease, of initiated AHEAD to than pave Alzheimer's the Alzheimer's of be that first filings the impairments. that disease. clinical Moreover, in the BANXXXX filings evaluate that of completed world the a treatments hope of introducing the trial, Eisai the disease that introduction collaboration first these We people decade We partners they're from way in aducanumab of multiple underlying the suffering after with regulatory work of decline aimed have will at geographies. therapies cognitive

bolstered stage both and companies, we Denali, leading Finally, development Sage internal and collaborations early our neuroscience Sangamo. late through including with and pipeline

evaluated terms on a of measured reduction effect as increased for are scale in Clarity March. in present ADAS-Cog amyloid from that antibodies X benefits, further earlier molecule enrollment aducanumab thus on The The in anti-amyloid placebo BANXXXX and quarter, for a that These demonstrated randomized me dementia. with the double-blind results about FDA. Phase optimistic Nevertheless, donanemab details composite in on amyloid by another to XXX clinical plaque seen trials produce approximately antibody also plaque trials first trial X the now third data that in potential the been its the in were produce being controlled COVID-XX related in plaque molecules measured forms fourth Alzheimer's clinical that progress the These the line of effect therapeutic now Eli from these timing we to as clinical donanemab Alzheimer's starting as show of that that disease. X to studies XXXX the and benefit. target for daily target to Phase antibodies in produced readout aducanumab our patients of the Phase Let donanemab, amyloid mitigate is Lilly distinguishing were aggregated Thus, target data centiloid top is turn to of a its AD/PD disease the QX activities with currently after we that released well results anticipated BANXXXX by Alzheimer's amyloid of the results target plan aducanumab of to comparable dosing continued anti- an as We belief these the reduction antibodies. was a-beta made recently meeting upcoming the Phase strengthen X concentrated show with plaque reduce the what remains Clarity robust and in in amyloid may and amyloid at robust Recently, in trial. forms unchanged. of the of amyloid plaque in disease. to living. consultation removal decline has clinical antibody results challenges These indicate

targeting which anti-amyloid addition misfolded, number hallmark when is therapies, to the pathology. tangles, of we of continue another principal Alzheimer's pursue a of tau, In neurofibrillary to approaches constituent

that prevent the the of the from this antibody tau half We study brain expect our data to the of anti-tau year. spread aims first gosuranemab, Phase of X in in

of of scientific a an with of oligonucleotide resulted was dose present multiple and reduction recently treatment tau. generally BIIBXXX study dose CSF learned tau effect. a collaboration to the well-tolerated meeting. in Phase Xb BIIBXXX, tau antisense total all in forms and phospho-tau and from aims durability disease mild reduce Alzheimer's at dependent plan to patients, that the have also that time additional baseline a production upcoming with ascending details We we in In targeted Ionis, We

finalizing we currently into disease. leading X are in tau, advancing plans that across and are as advance other targets Alzheimer's of Phase preclinical industry disease. amyloid BIIBXXX summary, a as to the Alzheimer's an study course We stage, In the seeks in pipeline alter to well

progress Union, significant MS made for we Turning opinion includes and a bolstering States and have application EU. of This the for in the marketing in positive in in a PLEGRIDY the to intramuscular United our approval subcutaneous the franchise. of VUMERITY TYSABRI the MS, CHMP authorization submission existing European

a for interval integrins alphaX targets utility by to evaluating the extended recently expect we clinical treatment readout for higher effector efficacious alphaX dosing integrins with highly We preclinical MS antibody study. has NOVA our of efficacy of binding MS. reduced midyear. effect a of affinity, The proved been that BIIBXXX an TYSABRI predictable entity added targeting that pharmacological Additionally, the study, BIIBXXX, pipeline. is a molecular and demonstrated relapsing has a TYSABRI, new in Fc function

first Our therapy. of intent regimen TYSABRI SPINRAZA enhancing as benefit and RESPOND patient of recently including that response the all of neuromuscular will clinical the patient in interval to In aim which is of the maintaining suboptimal had study, optimize our to learnings therapeutic announced safety, a so patients gene the who and disorders, efficacy the convenience TYSABRI. to effect SPINRAZA in dosing have continue high we evaluate dosed while to dosing from the integrate extended we

year. extracellular on sufficient study Based In can the were SODX recently patients secondary in in did X evaluating to alpha-synuclein doses in central movement a Phase X system. higher last engage the Phase our the with or disorders, the which the in We currently whether we enrolled greater of the to trial half ALS, evaluating in learn to Parkinson's efficacy the not believe look the have the that we forward data meet Phase we In were in readout provide that continue an second than ALS, BIIBXXX CSF of dose. samples to primary person to enroll disappointed also this SPINRAZA we DEVOTE in doses the patient and trial of disease study, tested X nervous we approved BIIBXXX, X is Phase endpoints. the

the can Phase our future disease. recently inhibitor for that BIIBXXX, DNLXXX, in target a that which of announced detailed engagement As study Parkinson's results data discontinue we future a set Nevertheless, we have reference inform of at believe small -- scientific BIIBXXX used a study to study decided molecule LRRKX known studies development as and scientific clinical present a meeting. result, high-quality to completion plan a be to future at the Denali pathway Xb provides met goals. otherwise of and

We in TMS-XXX an bleeding of up stroke, window care and we exerting reduce of expect the of the events. of extending to XXXX, and in TMS-XXX plasminogen potentially which in completed to are stroke. risk over expected Parkinson's of mechanism modulator additional or ischemic enrollment standard for the of readout is or initiate and of the to In hours the the the Phase damage. X.X is X about simultaneously ischemic remains first acute includes late TPA stroke TMS-XXX reduce the end XX stage plasminogen this clot, half believe recombinant significant facilitate TMS adverse tissue clinical anti-inflammatory patients small disease window of may trial for the by risk hour beyond, of of result excited currently to This therapeutic site a development of from at X in in while the effect targeted hypothesized help the the QX TPA, upcoming molecule this thrombolysis year. year. tissue advantages of We activator, or action selectively

reasons, these believe a potential agent. thrombolytic TMS-XXX For best-in-class we represents

enroll by the of edema cerebral patients caused Phase by the pandemic. the to the posed BIIBXXX of continue infarction, hemispheric COVID-XX for X despite in challenges treatment trial large We

therapy believe SKYLARK lead therapy postpartum business both. zuranolone and with a for accelerating multiple number potential of disorders, Sage, neuropsychiatry, collaboration X for X response we to highly development the are be into that for productive we've asset, in innovative first-in-class Significantly Finally, leader psychiatry. co-initiated depressive we our MDD oral the WATERFALL, has entered year, Sage's includes MDD, episodic a prevalent when We into therapy and collaborations CORAL, Major the Phase which anti-depressive Phase look to had therapies. expansion PPD very executing access in for or forward or that treatment zuranolone on quarter to disorder, first-in-class a provide standard front, upcoming a potential PPD. rapid of with MDD; readouts depression and this and a

efficacy efficiently a goal Beyond zuranolone, Phase to with technology ViGeneron's in we AAV development in in intravitreal potentially entered compared of Dr. which readout through retinal as by collaboration, XXXX. transduce inherited of clinic sub-retinal retinal via of we area Craig cells we capsids for will a we Furthering the ViGeneron currently collaboration the comes also therapeutics laureate, enhanced aim to to in proprietary commitment Institute the injections, significantly Atalanta with could injection Massachusetts, entered with to tremor, started based University coverage With via therapies surgery. Mello. performed our be recently, developing collaboration from treat SAGE-XXX this ophthalmology, the collaborate into on on the with Nobel and study RNA that offer at More expected retinal essential into diseases. a Therapeutics early X use gene

as Huntington's platform HTT treatment to This with of disease. As Atalanta, part our targets, ViGeneron ongoing of Massachusetts Infirmary, recent well with the proprietary utilize CNS treatments capabilities for assets multiple this our ASO disorders. including Ionis branched Scribe, collaboration, the siRNA collaboration with the our and in its for including Sangamo, with retinal combined develop collaborations gene Eye for and Atalanta will long-term and efforts our potential gene collaboration inherited of therapy, complement development as RNAi and extend therapy our Ear

progressed modalities drug key the the market technological transform with to and edge may genetically well state-of-the-art therapy on patients. therapies R&D employing targets. XXXX, Additionally, goal gene neuroscience accelerator of field pipeline, cutting of bringing the the Biogen challenges against validated focus we to a solving lives therapeutic In gene a that unit created in assembled more

eight of on year pivotal remain including transformative And the to result, a Mike. now we I of meaningfully believe promising are to growth call change pass four we therapy for believe clinical potentially for patients, the the We ahead As Alzheimer's programs. time entering will well-positioned neurotherapeutics course opportunities ability with are we optimistic first bringing anticipated, the trial over disease. their and readouts lives in a a we to the us. impact including of

Michael McDonnell

long-term. continue the declined $X.X at revenue versus billion, XX% review billion constant to mostly now actual grow year despite from for versus morning, leadership year for versus billion, currency. year and was cash and We by of the including both our prior quarter XXXX. with business and over the for of our generics the versus and X% Total maintain generics constant in actual and Total constant another currency. will challenges for full fourth Thank Total as currency MS financial prior multiple at $X.X had I capacity businesses. and decreased to OCREVUS the U.S. position the and the the to X% Al, TECFIDERA execute of you across revenue quarter driven the This OCREVUS at MS the our royalties prior actual quarter royalties year global This COVID-XX driven you, both by actual generic revenue for full TECFIDERA the the of remain U.S. performance the continue fourth guidance Biogen we entry year, the $XX.X XX% solid X% $X.X TECFIDERA year billion very including entrance share prior strong significant a quarter, was of also well, with revenue decline the constant currency. everyone. in for and and in decline declined currency. good financial both financial of U.S also core decreased Total

a competitive both relatively the the demonstrating MS revenue fourth business fourth and market. our resilience Excluding TECFIDERA prior in year, Global revenue $XXX including [ph] million U.S total quarter for quarter the versus of TECFIDERA, the year the $X.X was the year royalties, full XX%. in patient continued full OCREVUS X% MS revenue flat with TECFIDERA X% declined increased fourth U.S., Outside year year growth. versus quarter revenue of year, and $X.X of the of for the increased of prior and the million $XXX XX% full billion prior versus declined billion revenue of

MS several During global the year in the dosing. million see throughout patient revenue as and revenue pleased to quarter. of grew well-positioned the subcutaneous for were VUMERITY growth interval $XX quarter, saw fourth $XXX year play administration we X% was in in we to continued important year We treatment $X.X the billion of progressed the full relatively full revenue is increasingly was role continued an quarter VUMERITY trends. prior and TYSABRI including fourth versus million improvement and TYSABRI of believe global extended year. important initiatives, the flat

Moving offset as now fourth see we is at the growth larger SPINRAZA SMA. million emerging markets, revenue decreased revenue constant which actual from SPINRAZA decreased by XX% currency. currency prior quarter SPINRAZA Global $XXX partially exacerbated U.S., year COVID-XX. an versus at prior by of versus by with and the the prior to year U.S., Outside XX% the In the competition, X% maturation versus strong grew year impact XX% the European markets. of revenue in

revenue currency. versus constant revenue the and full the billion actual year outside Full prior X% year, at $X.X of X% revenue currency U.S global at SPINRAZA the and year decreased X%. XX% For year decreased grew U.S full SPINRAZA

Al, has of have care. very a foundation Michel you profile and impact new had to be and a heard competition SPINRAZA on SPINRAZA, safety and and Although as efficacy COVID-XX an strong we continue will believe from

of X% currency versus declined Fourth quarter at versus constant actual prior constant revenue at prior flat million the Moving currency. X% of of biosimilars at and Full $XXX was $XXX year grew X% year currency. revenue grew actual and currency business. the our million to year

and We XX% revenue new in pressure, new $XXX from biosimilar biosimilar developed year RITUXAN. of relatively the by within prior Our Europe. in the year Europe in to million with continues and by anti-TNF other decreased decreased continue and full by prescribed the we erosion well the as be accelerating and XX% of products to revenue anti-CDXX well COVID-XX clinic in Total the geographies decrease COVID-XX, the commercializing from negatively a $X as BENEPALI our to reduced with for due fourth be grow royalties JV products. anti-CDXX leading revenue Total number versus continued in and in to etanercept other Bioepis the believe due have is a XX% of increase XX% and opportunity as a continues be quarter impacted treatments impact we and The COVID-XX. slowdown provider to decrease RITUXAN. Despite OCREVUS flat one biosimilars the business pricing prior a product Samsung OCREVUS XX% continue royalties of biosimilars. revenue across from U.S capacity impacts as to to versus RITUXAN billion the in decrease the year, in revenue Europe,

was to are to revenue gross to XX% Fourth was of of margin. mix. margin versus due the of well margin and RITUXAN, XXXX year declines Gross in product now quarter margin The to high products both higher XX% fourth partner as in due in gross XX% TECFIDERA as XXXX. our corporate was related which Turning the quarter XX% XXXX. full revenue costs the versus for decrease

SG&A Moving and approximately was $X.X billion. quarter expense QX year, related related $XXX $XX non-GAAP of was approximately million fourth $XXX agreements Scribe, was of for launch ViGeneron. non-GAAP $XXX versus now QX collaboration to was non-GAAP XX% expense to to million, R&D with $XXX the million was including million and QX rate non-GAAP tax year aducanumab. million $X.X year this Atalanta expenses. Full SG&A to including XXXX. approximately related external flat includes billion, non-GAAP our Full preparations effective In R&D aducanumab.

Our in full XX% tax XXXX. approximately rate XX% was non-GAAP year effective versus approximately

value total During $X.X we stock company's value XXXX, million quarter, shares of the of XX.X shares Throughout million repurchased common total a for fourth for repurchased we the $XXX million. billion. of X.X a

there XXXX. the of $X.X under in which remaining billion of share XXXX, program, repurchase authorized XX was December As was October

approximately share year in the was the XXX guidance non-GAAP full the recent and count Full quarter shares quarter $XX.XX, was per we was the marketable our and XXXX, debt. versus were full in for $X.XX. for net diluted In range. Capital diluted year per share resulting free in $X.XX in increase with million flow in billion securities, $X.X cash the most ended XXX the in for and average billion. expenditures billion from $X.X million net above year generated $X.X cash debt, prior $X.X was approximately billion weighted and flow approximately fourth year cash earnings operations. billion fourth and a We shares Our year. $XXX earnings $X Non-GAAP million share diluted

Additionally, year. billion undrawn facility of of the our $X revolving was credit as end the

Let full me year for guidance XXXX. turn our now to

Changes and $XXX these We number diluted year be XXXX assumptions, and based million. per expect note could this is It $XX.XX $XXX is full $XX.XX of between a are uncertain. and and to non-GAAP results. expenditures revenue million that to materially be between $XX share; our impact $XX.XX billion; capital critical be between to assumptions important billion EPS which currently guidance on to in

immediate U.S., guidance approved we aducanumab expect will in Our June is would the the If assumes approved an decision. uncertainty by in the U.S aducanumab FDA's be remains X, launch. although on

in titration the months those treatment. revenue result will However, of patient in initial less per

a would As in XX% result, a of of not be revenue U.S., or A we size would modest XXXX, thereafter. separate we commercialization, revenue expect is only in net item, profit line for and SG&A. book aducanumab XXX% which share in of Post booked the R&D ramping part would

a decline assumption. sharp half TECFIDERA slower XXXX U.S guidance the we business unsuccessful first erosion during this the we while our expect is our in of than if are date has anticipated, and been legal our addition, to of appeals, In

put in that $XXX of was erosion at percentage. reduction related QX expect in license recorded U.S. which certain gross with significant gross the on We margin manufacturing XXX% will these one-time expect to the related RITUXAN TECFIDERA, from pressure products in we Also revenue the Along margin property, as XXXX, high also of in we reminder, revenues a million intellectual margin. our of

XX expect XX billion We programs which XX of R&D now X or investment in total continued including non-GAAP remain $X.XX our a grown areas to pipeline, across our programs, filed. long-term will $X.XX Phase which expenses and has are committed growth through be between to therapeutic We in billion.

stage Importantly, mid Phase we readouts expect to pipeline important in eight X. including year late four our generate to this

not billion will We approximately an between collaboration million million Of aducanumab. launch estimate expect this would and profit This of approximate SG&A. sharing, be post $X.X commercialization non-GAAP would expenses of and the part billion. $XXX amount, and in be reimbursable of includes be reflected support potential by Eisai SG&A $X.X $XXX investment as

In significant of manufacturing note we is if results have not important could that is to capacity our aducanumab, addition, approved. allocated it a to XXXX aducanumab portion which impact

We remaining share rate be and the of development non-GAAP variety assume tax and activity. of to portion expect $X.X the our between factors utilize a our we XX%, of authorization XX% for a depend throughout we will year, will XXXX this on repurchase including billion business although

tax or have any care XXXX XX, assumed any from Foreign not business net impact health of December exchange we And effect rates potential or transactions. development or reform remain potential as to are in acquisitions for impact year large the activities. from included of hedging

Going guidance closing back we full over the call to now forward, financial his plan our turn each year update quarter. to for I'll Michel comments.

Michel Vounatsos

transformative impact well XXXX and manage the demonstrated and continue the you, Thank in as of franchise strong on for make XXXX a company executing TECFIDERA generics Mike. to our strategy to year portfolio. we build as resilience execution Biogen to a positioning the multi

We leading an Alzheimer's disease. are industry pipeline for advancing

aducanumab by an waiting are early important in June. expected We the U.S now decision on

are belief in X. one we about of approval therapeutic our stronger. never of We targeting supports Phase optimistic aducanumab in described, been plaques and BANXXXX AI the has approach our believe the that data As amyloid

anticipate begin also tau with ASO. and of the pipeline new tau as late a areas are assets We such XXXX and with Phase include an needs, three by approaches stage clinical These year. in eight this readouts complimentary X Phase extracellular across targeting an we ALS, X expanded and medical targeting with pursuing number and therapeutic pathology by the MDD tau or intracellular pivotal of four stroke four We programs with and mid unmet to significant characterized end PPD diversified with readouts antibody an Sage.

MS, In we well milestone We important across as the interval of this launching subcutaneous planning potential and data on also are for expect are we middle the extended as our of launch TYSABRI PLEGRIDY intramuscular in significant business year. the dosing year. core

for aim our to build we to we meet the scale the long-term, of need medium patients. As to digital further capabilities

the our to develop of of to therapies innovative shareholders aid effectively Apple cognitive excited reiterate progression to potential are capital collaborating Alzheimer's bring part our to stage the disease, with decline. in efficiently, disease may and allocate vision to commitment our diagnosing for and maximizing over As earlier digital returns long-term. in to want at biomarkers I that lead we we patients monitoring to continue that This and appropriately. demands be

in demonstrated superior investment capital make. as returns an as the have well will we optimal we have we the always from structure for past, strive As to aiming

I like to long reflect commitment Biogen's would responsibility. standing corporate to Lastly, upon

dedication holistic developing diseases, serious we and to At not strive the patients of much therapeutics is serve. Our society society improve but only view from extends broader Biogen, further. a novel for we and broader the suffering to limited take patients to health

who more employees could inclusion. all dedication of have in achievements to on to access demonstrated and as passion well making and realized thank I a as closing, In climate our future development our and patients' the and around participants would past caregivers impact be commitment. and to the in world and invest a health, clinical programs positive we life physicians, not Now, equity continue than without our and ever, diversity like

the open for now call will questions. We

Operator

the Morgan may Please be line line. And from of muted. comes you Stanley. question first Matthew, Harrison Your your unmute Matthew Instructions] [Operator with

Maxwell Skor

suboptimal How therapy? line This design for Harrison. around about the Max expectations sorry long enroll are what define do your it will that. the how to of is Can to on you. Matthew take Thank on you Oh, elaborate the RESPONSE response gene study? the And study? Skor you

Michel Vounatsos

commitment It mindset in the you treatment. also answer. for have on will was the SPINRAZA terms the demonstrates question. Thank for we our clinical I the basically best practice SMA in inform patients. of the foundation good care having our as modalities and of to benefit Al? based It that for new of

Alfred Sandrock

see the on future, RESPONSE on study other we Hammersmith scores. improved will INTEND enroll a RESPONSE for be yes, determination may based It's SPINRAZA. based, XX The in be suboptimal the measurements is also study adding Yes. But and scale, advocating milestones on for physician based example, and are such we'll to patients. a suboptimal as motor And CHOP X-year of about that by response. whether score look it'll

Operator

move now Terrence from question. Sachs. with our hear We'll Goldman to Flynn will We next

Terence Flynn

the I decision Great. you had at Michel, two Thanks a approval in you can, know broadly. any to specifics, regarding include see pricing talk Do price just on probably anything not point questions. level? read and if versus a your share from the you're can biologic you drug care give you I strategy one. Good And aducanumab going more a just for early payers? primary here any you. but to perspective guidance. morning. then maybe high specialty this was taking your as I provide wondering Thank just can part this

Michel Vounatsos

represent we decide getting the But that basically, is the two best belief Concerning had And there. on, have, guidance this best which engagements stakeholders. the the assumptions there we reflection may see very moving business we basically price, these reality in that are are. it's main not speak. we forward. are which on basically that large dimensions. is how with we the We Providing while many the are we forward, Even moving business

The functional living. clinical potentially one first but of aspects one of and functions, equation. daily activity on is also This of the terms the in side is meaningfulness, cognitive

a U.S. $X.X per is more one The the cost important billion of which element the XX% too patient, we of not is nursing this on $XXX,XXX age these that wide our the we more the consider in than are said, for second than a And specifics. are mistaken, engagement main early give patients of the if society, year. home getting nowadays in million. the topic Alzheimer's more XX, I The in there, caring $XXX than By I’m more costs but as and its to cost price to of and year are

Operator

We next move will now question. our to

go Please ahead. Leerink. SVB with Goodman Marc from hear will We

Marc Goodman

how to they could morning. I'm on and just On don't data know. with it's they going understand for hard FDA long already all gotten, close how possibly working it's much given understand need, they been us else -- adu, the what your Yes, we're what trying good have to and relationship

in they on then SG&A, Was there of how more Just gating talk the launch? is if that any if trying just of was the in to that? data just going asking wondering And the approved spend not the you. just you're place? committed actually helpful? us clarity secondly, that the was of half I that the half half is much going for? situation of understand around from there type to of Just any of of first second was is give how could were year? color middle So would that you be on on study spend year? it's EMBARK year, to the that Meaning to any the be million adu Thank the in can just be Or all $XXX the you about going take to, --

Michel Vounatsos

part SG&A I aspect. the data aspect, the for part on the and first question. important Thanks take the sorry, second the on will great come -- back the will Al data

basically only concerning potentially So important an to product. opportunity the launch SG&A, we such well have one

we a the and by opportunity deliver deliver value could we major meaningful to the patients It's to are sought million clinical disease for We Al? what multibillion win. the to product So functional to able in for patients potentially affected U.S. launch the a be resource company. XX these first and basically,

Alfred Sandrock

to the course, which to And And under amendment major during that a that the led FDA. and review normal all recently, required requests been we're And from analyses had one the there a review. saying PDUFA clinical we've information more as Yes, led are process, data. of submission delay. along additional that we

to the provide Beyond on want detail much that, specifics. don't I to too more

Michel Vounatsos

a the sequence. color So on second bit part of Mike will provide on more your the question

Michael McDonnell

Yes.

So, morning. Marc, good

points a event the we think I we that receive gate of spend of in couple don't approval. best as it's note. Obviously, we'll can the

XXX% we obviously, You maximize mitigate. be a the would not would of but be and to expect mitigate meaningful would able costs, that portion to able mitigate those would should we we we amount that

Eisai, The in with just other is rate of U.S the of to is U.S., all costs at that agreement the reimbursable would XX%. the remind the which are we for point that that aducanumab in I on our subject incur substantially

out you the that's launch. accounting sharing And $XXX pre reimbursable through a million differs complex, the million when that and at that and P&L guidance come our the the little $XXX so about that look of on bit because gave, would collaboration on a there's in would be bit And that a was that, our reason in we is than SG&A, different you it line. different post is would expect why line ratio

collaboration is Some of netted That's the that Eisai schedule. rest reimbursement the the a and But of to come through at actually million that reimbursements remember. it economically, $XXX important in are line. then end XX% day, the

Operator

now move hear in the caller please. Evercore. to queue. with our Go We'll ahead, Umer We'll next from Raffat

Umer Raffat

how that basis Xs? the XX-week for in results, and much from my was just the weeks. of point Phase the you. that example, XX I Al, curve just do Thank dose be EMBARK were weeks with the off And Phase at, that with X? you curve last you of that a that. the to two looking titrating coming emerging XX weeks XX efficacy I comparing the on interim would data first Or what you're the versus overlay when first Xs so is guess Thanks initial taking through study. EMERGE about for look data Phase question. how you're I'm understand in I'm patient-by-patient first the first ENGAGE thinking the redosing I you guess are thinking challenge curious the in wondering

Alfred Sandrock

we're enrollment. We're still partway Hi, Umer. EMBARK. Yes. Thank through Yes, you. enrolling well,

X to of are an that that plan. that enrolling analytical half will year. pointed that just important that the addressed need you issues in right at first But, hopefully so yes, as is out good presented the soon first study we're or some completing still issues and this be the months we those first, You're enrollment or meeting analysis recent should be It's the roughly. the patients. in of But

Operator

on now question. to from Cory Kasimov hear with our We'll We'll move next JPMorgan.

Cory Kasimov

at question. the what half follow-up show guess, hoping BIIBXXX just you're to then anti-tau Phase can you. guys. a of the out you to ask this coming if first able are Thanks you'd up kind the antibody of EMBARK morning, this I the provide on if be And that's to them? AI it you pending us taking I of the for looks frame remind Thanks. here. design for read your kind X where Great. or to Good FDA information, taking question. Is in wanted requesting here was needed Thank trial -- just

Alfred Sandrock

endeavor so. asked at requires are And that still request. to provide for they trials Cory. -- or will whatever are thanks, Yes, so we will Yes, FDA still if looks that information their in ongoing, enrolling do we

in patients. In extracellular a is looking terms largely in substantial is progression shown decrease an BIIBXXX we're stage what for of tau. effect early have Phase to BIIBXXX, X on trials Alzheimer's in this -- has

a -- that spread cell. spread to is hypothesis cell from hypothesis tau so going of in tau and block to prime disease. And Alzheimer's It's we're the the that like of there's a

about Alzheimer's or to outcome the measures. progression course whether the we of typical X-year, the of going using not disease we're So see over affect clinical

Operator

Credit the Please to on ahead. next moving Seigerman, Suisse. our Evan caller Now queue, in go

Evan Seigerman

taking much for you the Hi, so all. Thank question.

earlier, how talking I'm comment reset picture, the So of XXXX earnings do But and of aducanumab, I'm made really mainly aducanumab your should outlook understand a that beyond? about if trying revenue about you be kind and a and and you. being Al, on significant other grow XXXX there comments, are referencing to Thank referencing. drivers predicated year. thinking taking out we your in

Michel Vounatsos

Mike?

Michael McDonnell

prepared lot the we said XX the very XX other programs, do to term. for we aducanumab much is got grow But the opportunities. the remarks, very that got ability over also of Thanks And including Obviously, question. as a the Phase company believe have longer in We've Yes. we've the we in catalyst. X. interesting

point is four a in we X. talked same. I of rich. readouts are the XXXX, in Biosimilars, expanding would very in X our existing which including I about, you As to products, would markets. lot the say international The Phase pipeline

think a we others. I great have and is Sage addition

the have we ability believe just company based grow do term is catalyst, longer pieces other aducanumab we for obviously, have the mentioned. that pipeline but to I the in what the that the on we and the So,

Michel Vounatsos

many we readouts So expect this year.

a why of X, of being company as I in the year data with reset, Phase Even there terms somehow And transformative four PPD. financial is is if for that's on Phase terms MDD based certainly epidemiology is and which in the unprecedented the So Xs. and qualified transformative. four potential largest readouts

it's the are stage, in ALS and they which So positive and And PPD, Phase we late hopeful. EYLEA we readouts in But is MDD, beyond X. in for had studies and there [ph] -- well. randomized this can business is that. those, aducanumab, on sitting beyond cash are pipeline we we we to on core And continue the pipeline. this solid, count Financially, progressing and resilient and very we have complement

So there believe. to are of plenty reasons

Operator

caller, move go to We with our will next Michael Please ahead. now Yee Jefferies.

Michael Yee

confidence the brought people for question. Thanks the follow-up over you good and design, Hi, that the as believe endpoint. obviously to Al, very this his is a to also possibly they had ask, used they scientific just Whether I for a And Lily. to morning. comments growing wanted interesting different placebo. a data around but regulators, community

comments Al, follow community about on, people how of as to it some who you're thinking even those just in that relates are Alzheimer's and could you a-beta. the with outspoken pretty maybe So about

Alfred Sandrock

plaque they humans to supports in and Lily get confirmed Yes, stages. started preexisting this animals had publishing began they they When it's anybody pyroglu-specific the XXXX. they to achieved imaging. the the amyloid that the same showed back they of on thing by after -- this that to Alzheimer's that had that the and would would the go hypothesis that. working I PET amyloid have think in disease And in plaque the on get into early they an you helping now that to in support get antibody to amyloid use antibody, in targeting found concept remove --

effect to study. composite seem somewhat a also they I use because of it's they great IADL, that I They a see think to decline. did small clinical and show it's think which measure an on ADAS-Cog

a couple or XXX patients, like XXX it's patients. think hundred I of

of disease. important endpoints we more had is Alzheimer's And use being it so, as the a they that field composed measurement all endpoints for sensitive the to But of endpoint. the in recognize

it approach. body suggests of the with adds that amyloid plaque plaque the So, the to that to and right the think remove get antibody right I targeting evidence is to

Operator

question next Stifel. take Paul will our Matteis with from We now

Paul Matteis

And you just centers can expect you do this make usable to be first much elements if number talk so of beyond of so, Thanks year. that six taking kind small you lot. where key was real could had capabilities? in on approved? studies real-world for kind wondering is you in the Is these I if what great. more a aducanumab? the about refining for MRIs the case of actually this of question. Hey, the in academic are your core I usability world you in that some a if end of the to Thanks Specifically, something think have intrinsic

Michel Vounatsos

Al?

Alfred Sandrock

requirements monitoring approved, for the is require But that timing ARIA, discussions useful and will and we quantity Yes, do the will MRI is approved. if world. with it's once regulators the so monitoring MRI be around aducanumab further there expect

Michel Vounatsos

mentioned obviously as sequence, is the mind an to targets. to probably we larger that in amyloid that most earlier, we starting the treat. Keep and substantial. time pyramid there have Concerning obviously are and launch will will is to expand And are hundreds over ready high-volume be that getting most beta done, these already confirmation important Yes. down centers with are this the

Operator

come with from & Company. Our Phil question Nadeau Cowen will next

Phil Nadeau

decline taking Thanks One like my In in 'XX. a there was XX% SPINRAZA's trends, Good QX 'XX QX on versus U.S. question. it for financials. about looks morning.

You in and Thanks. competition if of the competition impact also could the lost pandemic quantify subsides rebound versus those much and the might once so will more COVID, Curious COVID that trends. permanently? and patients you then be referenced how

Michel Vounatsos

add. are will watching we for this will I carefully. you Thank the And question. start then And and very Mike trend

pleased $X.X XXXX COVID. First for overall SPINRAZA of revenue are all, in despite billion we with

the as Patients dosing. So the of scared the team. in centers, is impact go from input so they the are to the COVID, delay majority to U.S., the the per

seen is the last alternative reasons for of very the towards and Some seen the demand accelerating peak seen year. also, rebound seen then to for return for treatments SPINRAZA dose to last in of in a sites but to that have effects. And following efficacy, those. of efficacy, decline spike we've the side some SPINRAZA least, patients of We've COVID some we've exists. least, not in been reasons closed Mike? perceived encouragingly but the deciding or to end a And of us, of for limited And launch, order patients. September, switch capacity switches not or we've staffing

Michael McDonnell

more describe growing I Not coming in lot as, attractive, a pandemic Obviously, makes you of we can health exacerbated Yes. U.S. to that. because a a is the oral an which of would that COVID, we in avoid the by idea facility. U.S. are to that say it care the add to competition, would outside still

So, the current that an switch off would our to becomes an to from an oral somebody less an conversely of that in environment, injection switch idea it's in prominent oral would situation. and more injection a little likely that somebody

think competition saw And treatment will of efficacy that do fourth become it profile, in all the safety much important -- and out impacts we the remain once exacerbated a exactly, day, the I and of both. bit the U.S., important in end believe parse get How is continue through believe at in little will particularly is the a it to the the quarter of continue is we to to that the we pandemic. each we point its really attribute option, but it we very SPINRAZA it to by hard So COVID. would

Michel Vounatsos

important for hopeful SPINRAZA. this is remain Again, we asset. So very a

an part remains to patients of convenience. of well research. and utilization two data the day, into experiencing will of rather and than As rates continue remains progression we it's better out drug the two SUNFISH reflected label the extremely perceived said play, the times, and the product invest the vaccination, this one remains, many documented efficacy end we hopefully with be broadest innovative with disease a of -- SUNFISH our in At

Operator

ahead. Olson to now Jay We'll with Oppenheimer. go move Please

Jay Olson

thank for and morning question. the taking Good you

Lilly's X Phase the remind finding profile, aducanumab please specificity profile and Thank Can how you compares donanemab. for PK for to positive the us about you. read from across donanemab? data spoke the You

Alfred Sandrock

Yes. is This Al.

binds the well it form on plaque, Donanemab So assay. aducanumab And it It's the present if amyloid of brain. actually thought seize of as the aducanumab a-beta, fibrils. aggregated soluble since binds It efficiently initially targeting concentrated to and binds amyloid of as in the plaque, in a is both which insoluble to as And to the removes such, pyroglutamated the forms a-beta, plaque. was dense plaque. to kind core. are early forms in plaque will, discovered quite plaque, based the you both part immunoreactivity oligomers of by

that in plaque So it way well. targets as

ways different plaque the of targeting essentially. So,

of characteristics too much PK, the an PK of has don't similar I of half other antibody. to it's monochrome know suspect It two since et terms In life about but I roughly roughly donanemab, antibodies, cetera. weeks,

Operator

question. to move now will next We our

We Please ahead. go Truist. will hear Karnauskas from with Robyn

Robyn Karnauskas

Good job. taking my Thanks guys question. for

donanemab. Al, on Another one for you,

that unique to clearing have it mechanism, the given that potential mentioned duration limited dosing. had to I after And Lilly of levels curious just competitive the assuming high do could profile? of CFO with plaque landscape the aducanumab? So was intermittent as can competitive provide clearance how you see the And you how competitive do think think about shape approved, landscape as that dosing the -- being aducanumab Thanks. is up

Alfred Sandrock

going Yes. Thanks, interesting. Robyn. be to It's

accommodate That as And tested listen concept as it'll and removal, FDA similar plaque that's at in of more may to of dose, things on time. for these which seem something relatively acute that something with hopefully Committee, particular, think there a associated say I When which other be studies. period and is, but and has changing I intermediate BANXXXX. soluble and I benefits will piece to they well interesting BANXXXX, think after you a or something have maybe options, therapeutic perhaps market plaque effects. be of seen with in side effects stopping that is thing be effects, about then synaptic regain other can the the remain that after future It's -- down-dosing after to there's I available heard respect been antibodies, may with think short patients with in restarting is being effect multiple it's second and evaluated oligomer of a patients. to learned after more may an be large untoward The that would Advisory removal, dosing across the some also aducanumab, multiple neurodegeneration associated patients have more will including function, drugs, be aducanumab, one you donanemab. one.

Operator

like have Looks final question. we one time for

We with Syed now Mizuho. from Salim will hear

Salim Syed

on aducanumab specifically. one Thanks as all color Appreciate on for as the Great. color, Al, me just well for guys. all well. the donanemab

So back lists, when the now go antibodies in and mechanism is the helping FDA the you're I a there made are the That the level is distinct an donanemab characteristics to anti-amyloid had case. impact seems like line signal a on docs, pretty point briefing their considered in eminent that of was cannot And et this the and as They binding at in have this AdComm it a beta differences the class. strong including cetera. action, quote, be molecular FDA that saying including docs.

class be Should is antibodies I'm So, beta-amyloid how at reconciled. people getting a looking single curious this as just all or not?

Alfred Sandrock

I plaque. that But really a That's make antibodies target and this comments my point really of not first generation of did in question tried morning. good amyloid sort the the to No. prepared

bound such that -- on were plaque pre-existing a antibody, amyloid XXXX antibody, which solanezumab, if an monosoluable plaque. they And to Lilly the was antibody plaque-specific and get concerned monomeric remove paper not For plaque, the read will example, a-beta. you to the

plaque-specific they solanezumab had antibody. while even in Lilly development, So a on working began

those what think have been antibody. not that I documents you And just to, it's so, anti-amyloid might've that's FDA that pointing an

in to and patients. have will plaque target those You pre-existing have remove plaque the that amyloid

issues also bapineuzumab, as aggregated as And It with as to soluble forms led was bapineuzumab amyloid bound aggregated. dosing. of well think I nonselective. well as that monomeric soluble insoluble to

we early I they I shown for that's assume better. should bapineuzumab not kinds may this reasons, so, patients, have that that think of I efficacy solanezumab think remove what right? and these target selected so, plaque next perhaps example And we the amyloid and another is carefully, generation not antibodies but in plaque think studies, Look, meant is stage of the clinical where efficacy. will that early humans. you all from for donanemab see And if those you And robustly target study the learned

Michel Vounatsos

Okay.

XXXX a day. So will we believe call. all Have transformative your to to and be good you for a for thank attention our want year Biogen, I

Operator

conference ladies may you you and We this today. will that, participation disconnect. for gentlemen, conclude And for do thank with your now your and

Biogen (BIIB) 3 Feb 212020 Q4 Earnings call transcript