BIIB - Earnings call transcript Q1 2021

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Operator

Good morning. My name is [Ashley], and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen First Quarter Earnings Call and Financial Update. All lines have been placed on mute to prevent any background noise. After the speakers remarks there will be a question-and-answer session. you. Thank Instructions] [Operator like the now Mr. over to would conference turn to I Hencke, Investor Mike Relations. Director, Mr. begin may you conference. Hencke, your

Mike Hencke

Good morning, and call. welcome to Biogen's first quarter XXXX earnings

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

of ongoing X our provided are Tables and includes in business results. a Table believe reflect better reconciliation our internally. to Our financial GAAP financials the and We GAAP X, X we financial economics non-GAAP results and manage business how non-GAAP represent of the

like making current expectations website are follow differ on subject We you joined Al by have for our related slides forward-looking based of Executive actual also risks today's Development; that on These beliefs. the that to Head am posted additional I materially. uncertainties we filings will point CFO, certain and statements, to our Michel McDonnell. and our out Vounatsos; call, I Mike which be to are statements our would and discussions this call. and Officer, I and detail. SEC Research the may to risk our discussed our encourage Sandrock, results On in factors Dr. consult Chief

the will turn we that you ask now kindly limit over reminder, a call, one portion the during question. to the As to I of Q&A yourself Michel. call

Michel Vounatsos

our joining continued serve on and have operation you priorities. morning to Good focus everyone, advance and execution thank us. With strong for a and patients we strategic

results company, first be operational together driven with first by performance biosimilars revenues will $X.X quarter MS, performance non-GAAP billion $X.XX. that the across solid during know we a cost pleased financial These management. and with of XXXX our ES continued researcher quarter SMA, of with were and total strong QX are While we for

aducanumab regulatory a will change we PDUFA significant FDA will the growth anticipate a in the opportunity. value to approval, to June be creation an the launch and approved, receive are Alzheimer's U.S. decision aducanumab ready therapy by If disease represent and first We X should of the we and cost date. meaningfully

has in the functional of for team in preparation working been for months aducanumab. potential the Our U.S. launch cross

have XXX Alzheimer's potential of that a of evaluated ready and We identified more care that the shortly patients key than to will have sites infrastructure We sites these necessary believe patients. for treat be after approval.

Eisai, that with health questionnaire. a hope to will cognitive collaboration treatment. awareness of enable maximize health and people of to team benefits by evaluate and powered at Together patients. working with in is pleased platform a to aiming the sites support take responses to We against us brain Alzheimer's along to capacity action increase our digital seek the we these an memory absorb identify in Services. BrainGuide Apple, order with is other aims of the to care currently which were influx upon Our sooner empower to based to Web people BrainGuide of BrainGuide, development Amazon Alzheimer's to biomarkers

Brazil, adding submissions submitted to aducanumab, Europe our We by highlighted an and has to Japan. Australia, be COVID-XX also filings access broad ensure recently including Switzerland, I are the approved we launch regulatory earlier to pandemic. population, additional that been critical Canada, to the should working am facilitate issue and to that a equitable underserved pleased outside U.S., in it announce in

year. approximately TECFIDERA continue and $X.X OCREVUS to on of products progress our worldwide U.S., royalties excluding overall MS demonstrate MS progress, to towards was broader revenue, in X% our TECFIDERA including the patients increased first, MS our the Turning priorities resilience versus entry of aside U.S., Putting the prior strategic generic billion. the QX number our the business

in growth current the guidelines. environment, to the which oral We a MS profile our U.S. and strong the testament our in were very We number competition current the this revenue new now one products our in strong product well. ability VUMERITY. product pleased VUMERITY, believe COVID-XX see is plan, mid-last a performance treatment well-positioned are year believe based to MS for of we our execute of on to versus is Importantly, announced launch to terms accelerate prescription Validating the team's

advance are new the TECFIDERA unmet in a regulatory MS. help China. address continue we approval recently that received excited remaining approaches medical We also need in Furthermore, to to

and Germany, we of an while for launched TYSABRI expected quarter, we and regulatory offers the in we first EU, in with profile, launch formulation we tolerability This intramuscular believe an obtain a EU, in U.S. await in the U.S. improved decision which the approval administration both PLEGRIDY of the subcutaneous

continue of important extended to year. also advance potential use expected with the dosing middle this We interval TYSABRI, in the of data for

SPINRAZA last remains perform the leading treatment of U.S., market the revenue Overall, impacts with Second, versus growth the for SPINRAZA we been to $XXX competition SMA year. which a foundation of that Outside discontinuation care. generated the XX% it SPINRAZA first encouraged while by very quarter revenues facing decreased versus we remain exacerbated SPINRAZA SPINRAZA last of see year. in global to well been will and million, were continued U.S. COVID-XX has QX believe is QX of of

$XXX of Third, million. revenue delivered our business biosimilars

that launching of We innovation COVID-XX Europe. capacity develop of right biosimilars the in continued are to countries X To clinic Bio-Thera will for Biogen quarter, biosimilars immunology has ACTEMRA, we gene we continue Fifth, to we Fourth, reduced biosimilars grow data cash in therapy and mid-to-late pursue at continue readouts tremor, new to and starts cash reported in currently capital for new the build progress RTP plan performance a state year. treatment We additional a operations stage this and approximately impact facility We our multiple we aim pipeline. as art proposed additional products. headroom a to our pleased Carolina. modalities. the create as flow patients in key resulted remains business this development. and Solutions referencing slowdown with in focus generated with and with million in meaningfully to to million manufacturing for have North expand our flow expect new end, in a continue to footprint. by therapy pandemic in of and our of financial announced essential to globally this BATXXXX will the BATXXXX, free Phase recently strong continue flow. cash to Phase China, in To generation end, flexibility collaboration allocate this which global area commercialize commercialize we Biogen recently the in our Gene site seven XXX us represents X on from significant provide announced QX. $XXX our We outside

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

Al Sandrock

good and everyone. morning Michel you, Thank

major quarter this forward number always, postpartum by advance depression, thanking to disorder, Biogen milestones like team readouts seven I'd to ALS, anticipated we year, and a our look to as We As for the achieved start choroideremia. in work depressive programs. and key their we R&D pivotal this of trials additional including hard continue

additional our in regulators and Brazil, Canada, Michel as me with filings submitted they Starting pipeline the to geographies, with Alzheimer's mentioned, review first Australia. continue and have EU, filings and filings Let disease, in as prior quarter the quarter. turn for now key in made we with now we engage Together aducanumab to our this Switzerland, U.S., across regulatory aducanumab the advances Japan, submitted the data. we in seven

lecanemab Alzheimer's Phase clarity the disease. Turning to last readout We or in early QX next collaboration BANXXXX, recently partner the Eisai look the forward enrolled in patient in study of our the year. X has to

was dependent The baseline mild-Alzheimer's Phase we dose total Additionally, reduction detailed that both year. well-tolerated phospho-tau Xb antisense meeting from disease and of this the and CSF results tau effect. from of to study reduce study at is extracellular. resulted upcoming later to present in of BIIBXXX durability tau-targeted Xb AAIC intracellular forms Phase a of demonstrated all oligonucleotide that time and with the and production in the plan aims in a BIIBXXX tau BIIBXXX generally

finalizing to in BIIBXXX Alzheimer's advance a into X plans study Phase We disease. are currently

previous to new MS, our risk the of when dosing. portfolio PML. as incidence analysis the data that of in PML Prescribing we the updated An EID data showed or a week. presenting across extended of that are compared dosing from findings this standard lower Moving interval TYSABRI at EID, is Program with with XX% supports associated AAN TOUCH reduction This of used interval meeting an showed with

as quantified physical, standard comparable MS, that may dosing interval NOVA newly data AAN, quantitative we XX being activity, meeting, mental social with using were qual, reported demonstrated subtypes biomarkers diverse as clinic. data dosing, of image MS electronic that from dimensions, MS with that in world neurofilament, position MS a MS of In aim more and holistic and disease than as instrument, high such key across of XX,XXX validated state we to MRI that by improvements showed which reported measurements assessed MS collaboration patient on can patient extended of new well around mid-year. health and of PATHS generate range or use the to to view line to and collected study, we interval with being maintain Also the is clinical make Europe is in PATHS discoveries they scans, we another as led the date A outcomes. as population records MRI are the have from study life PATHS. We aspects collaborating leveraging in health, MS More quality gain disorders. enlarging PATHS a the efficacy study lead clinically at leading the we assessed new obtain Biogen analysis being data using with to expect Siemens. which stages dosing pathogenesis. of measurements continue real generate social TYSABRI and MS neuro top rate a in as from insights quantitative are developed the such patients and key effects efficacy a of At of data in use been about TYSABRI interval by of methods, data as results advanced seen meaningful approved in drugs of of on how mental of its affecting ongoing MS to enrolled Moreover, world by by to analytical the real learning, validated lesions the to presented a showing currently evaluates and modern extended machine TX standardized software, through assessed U.S. PATHS, the AAN the neurological patients that instrument MS centers art prospective hope

The For eight recent first presented months, found follow at OCREVUS. patients results We greater indicated almost that randomized symptoms improved with self patients. or therapy. a that XX AAN XX% quite was VUMERITY a using individuals X.X% study treated the the XX profile VUMERITY rate remaining with of The to the tested, improvement X-week adjusted study Also TYSABRI adherence that than compared of of events for real interfered assessed Phase the and GI that at at due will a XX% of was to treated of believe retrospective to regular that demonstrated multicenter VUMERITY extremely is domains the X.X%. EVOLVE-MS-X, differentiated lead adverse being of VUMERITY administered was treated activities, patients. to treated high, patients patients bit GI study discontinuation low for that of and overall tolerability analysis GI questionnaires. world These TECFIDERA of with VUMERITY with of of on XXX persistence only treatment publication TECFIDERA tolerability X those as

in leverage our as space. antibody to build established anti-VLAX to the seeks MS BIIBXXX, remaining to our the MS. pipeline of remyelination addition success efficacy aim to as generation oral our program BIIBXXX, the in address In high unmet our next well our treatments, on TYSABRI need oral This includes that inhibitor we BTK

as in the testing study higher enrolled DEVOTE meeting followed AAN Turning an A this safety are of dose The the efficacy. well-characterized currently for to cohort, greater SPINRAZA. profile of neuromuscular the consistent its up five update dose disorders, patients XX with dose approved were ongoing profile of openLabel on Part Data months of the the we week. safety higher to evaluate presenting from milligram development the SPINRAZA continued potential supports evaluation a the emerging at safety the approximately we for

released major therapeutic observed that of in depressive milligram Safety openLabel in data severity cohort later month, of forward analysis We the study, depressive of a and events to an supports two XX% X the Phase treatment us approximately similar XX with the study. containing were believe look of SHORELINE to half as study cohort, event achieved data first evaluation at more zuranolone also additional readout previously SHORELINE to positive quarter. complete and CXORF during ASO neuropsychiatry, for an XX with The Phase including patients with expected additional disorder. the XX in to of X been the week study Phase the therapeutic Therapeutics Hamilton item XX treatment, following dizziness, X participants scale XX% major both initial the zuranolone treatment interim data. potential by the In anticipated in for supportive a We but the data more depression. one-year the naturalistic required Sage year. cohort also of of patients enabling conduct treatment of an that added escalating the has rating In readout further the completed of an milligram zuranolone cohorts, consistent showed to waterfall more the dose, this the of ongoing BIIBXXX, response adverse cohort the somnolence, cohort study response of than these profile SHORELINE zuranolone. zuranolone effective be milligram frequent and reported XX-milligram evaluated milligram showed ALS. XX% is and most the one in positive now XX XX-milligram were The index. to of in disorder the sedation cohort, the our a in last to of zuranolone, we additional milligram two-week events, Adverse XX demonstrated in seen next

of In primary SAGE, clearly trial be the profile somnolence in to dose, statistically turn disorders. in could from a met In baseline, to as reduction placebo but significant like movement this the collaboration endpoint would known limb consistent in demonstrated recently concept previously efficacy XX% receiving patients Tremor of reduction tremor shows the to with BIIBXXX, BIIBXXX data. components studies, in was going test in milligrams. dose established XX. with whether and I in patients designed essential that the XX% tremor incidence pre-specified Next, TETRAS also corresponded from day or announced of with Rating on discontinuing at proof upper of a dose X an upper we also a BIIBXXX lower determine to safety score SAGE-XXX, to the our reported compared of established was but compared This Phase Scale effort XX% placebo. a of limb high-end XX% tremor BIIBXXX not essential patients treatment. essential to the at amplitude or reduction Assessment This to baseline to range XX%, tremor, of XX

complete, interferes SAGE movement which with support disease, believe activities unmet plan Xb Parkinson's BIIBXXX. now of safety The essential clinical approved and were Phase with in X development the is most we The treat molecule inhibitor goals significant. been need next social more steps Phase patients and with essential issues living continued engagement. in In tremor new closely biomarker the no than use hampers working this essential small There five We studies LRRKX tremor, a their development help daily drugs currently that done limits and of have of to are for achieved, BIIBXXX. for common which have of practice. tremor tolerability own, in can and disorder drugs be BIIBXXX, their believe We tremor to used more decades. of to are the

clinical with Denali, disease previously we stage this in the patients collaboration to our As partner end expect announced late Parkinson's of initiate development by year.

depression, believe the will pivotal excited end there's organization quarter by including I R&D additional the year. Our major expected call Mike. over ALS, of the readouts the be and year, about number in We readouts disorder, with of depressive first pass in the of now choroideremia. important delivered postpartum a to seven much to milestones

Mike McDonnell

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

COVID-XX XXXX, X% year. $XXX Normalizing the growth. the patient U.S., prior for approximately X% increased in quarter outside MS including business MS relatively Global market. the in of total declined a year. Excluding for XX% Outside versus royalties TECFIDERA to of shipments million of demonstrating resilience prior competitive accelerated U.S. revenue U.S. OCREVUS of of revenue $XX continued of due million TECFIDERA our revenue the with $XXX declined flat, first the were quarter first million versus TECFIDERA, the revenue, QX

product improvement $XX now first in in share the revenue number million trends. During X% and million revenue the oral prescription of first TYSABRI prior we terms the quarter quarter global of U.S. quarter, is was one year. versus the new MS VUMERITY the declined $XXX in in VUMERITY saw continued

XXXX, approximately revenue the for grew by Italy. Normalizing shipping saw in adjustment $XX X% million, of due to increase days pricing the revenue in in X% TYSABRI combination in reminder, As as dynamics patients. extra a and benefited U.S., global these QX TYSABRI of we a a year-over-year,

well-positioned continue we the administration, an MS interval important treatment role several We initiatives, subcutaneous including progress increasingly play and extended important is dosing. TYSABRI of as believe to to in

X% we decreased XX% U.S. due at decreased prior patients In $XXX continue year X% at the now currency, versus SPINRAZA year the global see SMA. in to the impacts to pleased SPINRAZA were exacerbated quarter Outside currency although revenue competition growth we approximately to to $XX Moving in year. constant the year, first and SPINRAZA XX% Global prior million the of XX% versus XXXX. million, of as of shipments revenue versus prior by revenue versus grew actual the impact SPINRAZA of QX including prior see timing the from COVID-XX. U.S.,

business, Normalizing was Moving of currency, to the now revenue due of our QX for flat accelerated XX versus first decreased currency. year-over-year. million prior biosimilars of in shipments and year XXXX, at million X% $XXX revenue to XX% constant quarter approximately actual COVID-XX at

OCREVUS one of to Our believe and by within XX% the Europe. XX% COVID-XX. year, well RITUXAN increase revenue the first continue biosimilars and continued U.S treatments in business prior versus offset impacted decreased XX% the biosimilar geographies product commercializing continues be due $XXX approximately the across a BENEPALI anti-TNF the new Europe, in impact prior decreased of have reduced revenue well Despite to leading as million a other to prescribed capacity the in by etanercept the anti-CDXX and be royalties. to quarter COVID-XX, provider new as we year. pricing pressure, in to number opportunity Europe continue versus slowdown we partially be as the clinic We continues by products. negatively in as Total to grow

RITUXAN erosion biosimilars. We expect of due continued to

XX% high now to due QX both revenue, down prior to TECFIDERA XX% continued first in and which products. The are margin in quarter gross the XXXX. reduction and margin of of Turning XX% primarily margin of in margin, quarter was gross in the gross versus versus was declines down RITUXAN,

gross continue margins. We expect pressure to to experience on downward

expenses to expense R&D and non-GAAP first was sheet, quarter the Moving million. balance $XXX

$XXX the was to Eisai. quarter First of the of approximately was of quarter reimbursement effective approximately rate aducanumab, preparations million non-GAAP first SG&A net XX% XXXX. In XX% approximately related first non-GAAP including tax from quarter our in million, $XX versus this for year, the launch

the for common the stock we X.X of quarter, During $XXX shares million first repurchased company's million.

XXXX, portion XX, authorized a to XXXX, and there of under this the repurchase year. in program share throughout billion was March expect of As the $X the remaining of remainder of we October utilize

Our in we the shares weighted was the was per million count share million for approximately $X.X generated debt, in first first and marketable approximately quarter. In ended flow share quarter $XXX operations. diluted Capital $XXX from Non-GAAP million earnings cash flow $X.X diluted in in net securities, approximately in quarter, We average million. billion XXX $X.XX. with expenditures were billion the $XX billion resulting cash free the and $X.X was in and quarter debt. cash

quarter. In the of addition, undrawn the our as end revolving was $X billion facility credit of

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

remains full-year guidance which despite to billion revenue moment. explain XXXX billion unfavorable will $XX.XX dynamics, in a I Our currency $XX.XX at

$XX. previous $XX.XX non-GAAP guidance are increasing between We diluted $XX.XX to to our range range to a of $XX from our of EPS

assumes foreign XXXX expected X to activities. dollar million. due $XX in guidance is that full-year of to the of headwind an XXXX from of we primarily to of despite our of our $XXX the March $XXX guidance are January U.S. Our currency It of million through revenue of net hedging reaffirming for unchanged guidance XXXX. the March guidance, effect million XXXX that XX activities remainder approximately strengthening revenue hedging XX, capital of exchange year, to net This financial is will note at the expenditure remain as rates important

launch. the XXXX, the to uncertainty is aducanumab approved in X FDA’s in will on although the If remains Our of an decision. by June immediate be expect guidance assume approved that continues U.S. we U.S., aducanumab would

months result, However, per we would as in a XXXX in will patient only dose for in initial ramping and expect thereafter. result revenue the modest treatment, aducanumab revenue titration of less

TECFIDERA continue U.S. RITUXAN business, of U.S. We significant the well our erosion rapid as as expect erosion in to of

be decreased these gross reflects high We margin dynamic. full-year this expected be revenue percentage. XXXX QX that margin billion non-GAAP SG&A will gross and now that and expect guidance expenses SG&A billion, pressure of We as billion. R&D new between XX% from $X.X potential due on and in we will second between in billion investments put launch. readouts, quarter, our will beginning the reflects which margin $X.X that R&D our $X.X revenue, $X.X non-GAAP and This Note products expectation collaborations, will was increase and program aducanumab both the our expenses to prepare for the

approximately estimate part collaboration SG&A million as of an full-year of Our potential profit sharing commercialization, be continues aducanumab. would support SG&A. not $XXX include the in amount, investment reflected and to reimbursable Eisai by of would be post Of approximate this launch million and $XXX

our a expect of variety We development factors, depend the a throughout of on the will activities. year, repurchase including utilize this portion we although remaining authorization $X billion will share business of

And potential We turn included acquisitions have tax Michel or any transactions our business his that, closing or development back healthcare or I'll reform comments. guidance. impact for over from in potential not call from now the large with to any impact

Michel Vounatsos

XXXX for leaving mounting. demonstrate By track year their remain Thank the Alzheimer's dollars. deprives for year. per of many Biogen first and will year. the approximately strong and disease for burden at approximately the of people million creates billion on at of the be the an a large. of and can transformative in milestone the their XX, in believe home Alzheimer's need with $XXX caring make to the cost Alzheimer’s nursing per society to and This for we patients of Alzheimer's tremendous for $XXX,XXX Mike. XX% be resilience The cost families, cost potential year starts we of of company. cost to you, unprecedented quarter continue of over U.S., and over probation are execution a independence. a U.S. patients half potential patients, with And disease aducanumab course in approval society a The aducanumab age a Alzheimer’s of unmet approval the

including we expected four aducanumab, want disease, over look our our we work seven such efficiently in ophthalmology, to areas shareholders and range mid-to-late neuroscience of stage as bringing portfolio. multi-franchise effectively, demands as and maintaining this to depression, to I that managing pipeline a advance long-term. we a our readouts to capital Alzheimer's stroke create maximizing patients We continue to Beyond reiterate Across These continue therapeutic year. to the commitment the to ALS, and innovative Phase operational to and allocate X. while returns costs. therapies discipline forward

capital will an have well demonstrated we in always from past, returns we strive the aim investment have we As to the as make. optimal secure, as super for

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

with purpose extends address advance society broader not At we Our much humanity. patients Biogen, to dedication the and but diseases, developing patients and challenge to science limited work to only is to long-term novel the for facing therapeutics serious urgent further. suffering from

critical and world like employees to our we we dedication actions across ESG across would thank that our accelerate closing, physician help have to underscore and development a making to positive who to I have than we all participants corporate clinical decided on this impact around these governance Now, priorities into the an our more scorecard ever, continue caregivers in commitment, issues. ensure programs. company. the environmental, the and To incorporate social, In of patient’s strengthen demonstrated lives, to the metric

commitment. are be and through passion could and without We challenging achievements living not realized a with our COVID-XX times

questions. the now will call We for open

Operator

Jefferies. first Michael Your ahead. from [Operator of go Instructions] comes Yee you. Thank question Please

Michael Yee

comments MRI you could and potential uncertainty optimistic morning adu, you. the monitoring maybe be just guys, and does you've if of there the Thank for some smooth? Hey, sites good remain if question. that logistics that that thanks done lot about there's comment fairly so nature, things and will confident pet get you for approved, you've you work could I make know of approval about was reimbursement both a around and It how the that done quite are I this work and just and a payers? sounds you like with wondering about

Michel Vounatsos

question, Thanks specialists we focus terms first and many a availability since assist was know that influx processes patients. that Michael. large of team of are U.S. the anticipate there if the infrastructure bottleneck. for the of and diagnosis capabilities advice identify in of because a of very to the the care We in and months The will be, approved sites

care, So, more order today. and to we to many of in anticipate the approximately around on ready to country all identify worked prepare treat, We the have had XXX the but sides those works. we

and monitor a we and operation a fine team [formula dose cross who ability the in-charge what? the are am the So, the the including is medical where engagement And progress the pleased welcome releasing], each the as managed review with team readiness. of functional with pleased terms in patients, to this I has the So very we work, scientific the to work started done the processes and such to of patients, the patients, sites, time those I diagnose the obviously we with thorough to patients, and launch U.S. by and was in are leadership.

different overlay only physicians, bridging, of the patients digital we pleased that with the some an and but passing stakeholders, capability [awareness new also reach are also services. contact end-patient and the is milestones. building] towards are We I am not

CSF nor that we believe I is price, PET not neither far, path reimbursed are U.S., so in a know, you forward. U.S. in there, the Europe, there are the but think Mike. amyloid we reimbursed As Concerning CSF in is

others with and many aducanumab the a stakeholders considering pharmacoeconomics, know, have engagement burden and with thorough, disease the the times the will clinical different We have and that of engaged meaningfulness bring. ICER, in U.S. including beyond. we And done you

with for And So, we because the Eisai fully launch. And gift pleased ready. edition in the also progress. I'm are such must a from team And three appreciate the months readiness. were the that for collaboration a like ready team, launch is actually, never think this the I I

Michael Yee

to Yeah. Perfect. you. Look Thank forward it.

Operator

question take Please from We'll Ronny of next go Gal our ahead. Bernstein.

Ronny Gal

market have is, getting the the taking I'm going to your stay thanks will market everybody you're – you that on the for I I [usual if prosecuting the win successful settlements, appeal got extent you morning, to TECFIDERA, few those agreements or That that impact to Good in Hi. are on a or able discuss the how – call. exit the know you they basically an patent], will can you wondering if appeal? products market? and and were to one if the

Mike McDonnell

Yeah.

So you the could for any we first the Ronny Mike. Thank at we as appeal XX expect on time this April sit know, it’s the And, half do in now. you question. you to hear we And generics are on There that really as something year. here said, as worked many come of news team overturn decision. know. try and to are win legal market, winning obviously, good that to forward the our very on push this be a successful, be hard this would has the that And would there. appeal, on there extremely from the we appeal extent but To

type would react? to would the so a would generics steps news, in It up And get good we navigate from would It's financial happen. have come how potential to, to get market we order a it little be be that would through of have to before there would now of that you know, calculate go and the where of the are premature to it bit hard predict, and immediately. in number on finalization that benefit, actually you be would additional quantification to we hard to with, situation and would the a know

our So, knew I of like. what news, would says. have we in in And would that would we it communicate evaluate very we're would terms it very what believe to, ruling looked more be course case. as good soon hard, the as benefits, of and that, we sort good say potential day working obviously, and But and we

Ronny Gal

allow this sharpen do you a just that bit, any settlements will have on generic me market little stay longer-term, win? any even if you Let to the

Mike McDonnell

can, Yeah, of we that Ronny. that's know, something on specificity, with comment not kind you

and where, – more it know, we'll overturning I You and very very to hard you and appeal that. something this one But again, communicate what we apologize team exactly we're for legal a we're hopeful great this hear know, on soon and that's yeah, very again, is all working have means.

have market in really we the we that see the generics reaction we’d the the and to of know, look have and could are before at the that. answer ruling specifics to You

Ronny Gal

Right. Appreciate it.

Mike McDonnell

question. Thanks for the

Operator

of Goodman from go comes Leerink. Marc Our next SVB ahead. question Please

Marc Goodman

Thanks. you States, Good talk are us a SPINRAZA big of on Yes. us, that the there? maybe booking Is the some morning. outside regions underlying just color what's that China, you and you sales? and know as on Can about TECFIDERA, opportunity? more United the you view going that you at give trends just, And help then something can

Michel Vounatsos

the for question. Thanks

pleased We and to we U.S. some ex-U.S. COVID, of discontinuation face the convenience. with the the compounded of are [indiscernible] performance I'm you due the in with performance also the modality the the effect if, enhanced even perceived the very did SPINRAZA pleased and with also know

from resilience learning so coming a momentum growth European the emerging there Europe and we to see to that strong are and see We in very apply can U.S. the ex-Europe. in geographies. can fast markets, And a of lots of very are core

very So, pleased. all-in-all, am I

of decrease, with fear think institution [indiscernible] the age some where set not dose of [difficult I part the the basically market, visit all is the gradually reinforce above vaccination, basically pandemic moving five. [indiscernible] the all switches. know, or of limitation forward of that is limit data the adult issues] improving that will product to of toddlers rate the largest that the toddler the and which for the continues faced the reasons increase, the the because have weight that to with we young terms we efficacy, while the and young in adult of The is

with good agenda priority have of environment China, So am the you the allocation, and in about on in Concerning diseases pleased where Biogen delighted less in nowadays, am very learning were and we should so approved emerging rare long, TECFIDERA, so will for pandemic. of product it's I know, the that. the for momentum. economies not where resource China ex-U.S. in second probably terms you a know, obviously, I from U.S. the benefit an the

the there market my I this fundamentally two previous already of I the for As world. four into And that believe during company long-term the posted is was in you know, years number potential with my family.

epidemiology the one is is So, with emerging similarities with West. the demand of tremendous. And rapidly

extremely of for is with X% low. The patients. of rate the So, more diagnosis XXX,XXX than still is of treatment but incidence rate MS, they market. are and than It's lower less the the [DMT’s]

a hopefully. with So, high, great and time the gives disabilities Biogen. to is establish are opportunity rest it China bit TECFIDERA an for a important together portfolio the market with of more

[with We managing Asia-Pac China. from are Japan]

a partnered on with We a biosimilar. Chinese have company

rest, geography. focus the don't good invest XXX only than questions. we in China, the it's you an the it's we great So the but And on beginning. lose a momentum more Obviously, team, have people. for Thank

Operator

Yatin Suneja take next of go ahead. question We'll from Please Partners. Guggenheim our

Yatin Suneja

Hey, think about, two-week durability you dosing Do period? might durability, powering zuranolone; guys. we I talk and have you. on my waterfall should after expectation you you know, and question. maybe you the upcoming for know, the from XX beyond Thank need beyond importance Day you Thank to structured endpoint? study? primary taking can the how question the about how a [indiscernible] be The of the

Al Sandrock

will there's Day the Day XX. so secondary the durability, primary And, XX. Hi, efficacy Yeah, this if And, you at endpoint is the you two know, is Al. know, key endpoint is you a more score from XX between at what efficacy HAM-D does the ways importantly, to in on perhaps stay or separated XX the patients. Day it that. on happens treated is, look One and placebo Day at

treatment, SHORELINE, entire needed data shows of XX% that most one important from latter look treatment from need think precedents, to need durability will to at. at of I think the one And about additional then course, be is prior you at at additional comes for treatment the who responded patients the the I initial so, more than former. the which But that looked course both most And key if year. an probably

are of that So, both think durability I important. kinds

Operator

Umer next Raffat ahead. from take We’ll Please go of Evercore. our question

Umer Raffat

Hi, would questions. I'm done through XQ versus just $XX repurchases understand to thanks I would taking over been magnitude XXXX thing, and And and were but just better, repurchase Michel, I the I'm to XXXX much billion XXXX. can't trends that necessarily trying realize at drop I in process so XXXX of doc XQ understand a looking better. specific like just that the to my for XQ Michael, understand in around that's billion between specifically the XQ worth there? correlate thought love one done to we

Mike McDonnell

it’s the Thanks for Umer question. Mike.

say the be utilize a in buy continue we $X accretive said. committed investment and to comments. the $XXX as repurchase did and as to that, we a of a throughout and year, stock we So, and very to couple buy the back I very you of billion stock would our the rest quarter our million authorization portion know, will remaining we see to continue continue share program, we back

availed U.S., for to profitable I that's a a base rapidly. think to in you Obviously, cash the billion. you shares product if of repurchase, generics Biogen’s years, look order know, prior say there. entry million of flow And opportunity was revenue TECFIDERA. have that of the something for on great levels I do would that that a large of You we've the differentiate back total five XX highly a certainly value ourselves of now $XX with And eroding pretty

don't that, quarter. cash free flow of to during the end still even committed of we had There we of a level hand very hand $X.X meaningful we remain cash of but that generic now, flow, amount differential than prior share and various the at the billion on had is And a level prior cash periods said, cash to repurchases. of to excess situation. a have the we of in the more obviously, lot that we So, do have free with we with time, have on

million number. what a robust the still of continue meaningful opportunities. is to can confines pretty within will remain very very we BD of XXX a evaluate do, And pipeline So, we we committed.

we a repurchase BioThera that And will continue with in do probably to to opportunity continue the to and excited investment will that. biosimilar in announced wherewithal We have invest those, that we about, you saw shares. we're we

it, So, read because volume investment. a I too that accretive the not we into as committed something we're to much as continue wouldn't sign being a see we're to very that

Operator

Please We'll of take our Morgan go ahead. next Harrison Stanley. question from Matthew

Matthew Harrison

space just of up. know, and studies, what is that's if in seen you comment could Thanks. just tau, your some was readout Great. the of you Al, on coming we've given confidence level from you other the wondering Good morning. I what

Al Sandrock

extracellular Well, prevent negative trying of And right, Roche our mean, that tau tau, you is about which do the think hopeful. to to cell-to-cell. remain Matthew. the that us essentially it's tau I gosuranemab but target antibody, targets with an know Hi, make results Yeah. you’re BIIBXXX, that, we talking spread antibody from you're tough

testing from several data of stages our plus results large own And the Phase doses. the seen a yet. haven't in we're Alzheimer's. XXX patients We study, it early X It’s testing

as looking seen we're of scientific tau. in Phase time and excited this reduction Very found we dependent the it's I no results in it's antisense to tau Phase tau. X It's a a we're I to good at affect in sharing my comments So, intracellular decision prepared mention go, that to forms the and a approach that'll it and very in because different different dose approach and did study, to meeting. X. tau BIIBXXX both about results robust terms go a should expression, the extracellular think enable an later those decrease in and production of of using year forward CSF,

Operator

take question RBC will Capital Markets. Brian our Abrahams Please go next ahead. of We from

Brian Abrahams

safety thanks taking you both guys, would benefit requirements a be what the think the for preparation for in maybe latest would guess start so I world your On who my question. as Thanks. studies, most and setting? patients on need to monitoring Hi, views you and maybe remind us, Phase aducanumab, can much on what well for those of again centers in real risk have optimizing management appropriate monitoring, X as adu?

Mike McDonnell

almost the asymptomatic. less or X to are – them you is likely them Phase The many. terms the for trial. that X don't get treatment obviously exactly trials, treat, on the And I headache were down such they But you main extra the most ARIA by cautious how adu because which symptoms our remind or symptomatic our you I get ARIA-E first the time longer done as risk we need the with scans ARIA-E. used trial, in of monitored believe the year And were standard when And six within yet. when very of nine And get as sequence and the will were the was We think had we depend need Phase of if were that scans. with in we that readily in you'll the associated about we label, I'd we of discussions, we’ll in monitoring of to ARIA-E. Brian. MRI would to all adverse event that's mild, Hi two-thirds most – say were asymptomatic. have being generally confusion. don't many the goes

sites standard private So, practice because And every access center, almost I it's I think to it's the think clinics sequence. I virtually event. readily dealt with, all, said, I – readily mean, managed and even a as MRI, access adverse – a have ready

going major monitor to to a So, problem it's think I for ARIA. don't be

Operator

Colin Bristow question UBS. our go Please take from next ahead. of We’ll

Colin Bristow

Hey, good the morning and congrats quarter. on

enrollment reduced around But enrollment X,XXX I the it slow drivers arms On from aducanumab [feeder and was just color the could the of X,XXX. could wondering, data most do your this? you believe – planned enrollment if for from you I us placebo you any rates on have a give arms I expectations? the to you give versus Thanks. us some Was the [EMBARK importantly, wondered the trials]? trial],

Mike McDonnell

as to were don't track. part arms. remains enrollment patients, though, who actually that eligibility I'd feeder reduced. not But were said, was on whether on on EMBARK. medical Yeah, requirements for as the data say of to the predicted, by the investigators enrolling, that the remain have many rate total enrolled there thanks is you in differential as track. I patients requirements, And number from of as enrollment And main is eligibility that enrolling for the of different met be on were the well not interest reason EMBARK the enrollment enroll high. or noted, does the seeking that I patients was the question. as the of there's it's level And

Operator

Credit Seigerman next of from Suisse. We'll Evan take our question Please go ahead.

Evan Seigerman

my for us on of SAGE-XXX, [indiscernible]? arm. the in discontinuation high the you touch for commercial just And very you recent a to had you thank of question. readout the what can primary, asset result] did I data this Two in you. rate on successful all, somnolence the we taking trial? a [statistic remind wanted Hi the while acceptable how plan pivotal in you a things, treatment Thank is to rate mitigate see

Mike McDonnell

and now result. will, I stated was that, met, the thing primary tested range That's I I major endpoint obvious Well, you're since to is correct dose SAGE the think for The of my my high-end perhaps want colleagues do we a [maneuvers] whether up reduce in that. other at we congratulate comments, to at a the which as would maintaining adverse can as mitigate key dosing titrating, easing dose, such may algorithm, if the the the while some dose, be approaches efficacy. looking There you other see and the to subgroups. events to include of potentially changing

In definitively. thing terms of what's acceptable? that's a I think tough answer very to

with doses that patient between they drug. perhaps what's situation, that to doses that'll choose patients issues think see themselves there'll the from benefit accept benefit them the patients the tremor. going be risk. a several I allow have for this one optimize and of versus And every can that to receiving with on day, day-to-day the It’s they the a drug tolerability at they're looks in decision and make the probably

Michel Vounatsos

X, of with or the so team XX% and than that do the discontinuation. think have approximately symptomatology I initial this try is to development, better of mindset what Evan, stage to XX% this we at seen Phase

to the fascinating but So, better. you the all it's is should about asked. mindset benefit It's that do risk, you a question try

Operator

next from of ahead. our take go Jay question Olson We'll Oppenheimer. Please

Jay Olson

study consider question you to experience aducanumab, strategy. aducanumab will that will TYSABRI? subcu taking to substitute for replace My subcu since was your can you thanks your subcu my us you as of how a Do TYSABRI or question. eventually and Hi, remind a And your IV from form about apply a complement IV TYSABRI about aducanumab? for subcu of there TYSABRI plans subcu is

Michel Vounatsos

the So, question. thanks for

is slightly current favored TYSABRI, environment beta versus high the excited depleters. are by eventually We is cell momentum the a that we behind efficacy in mechanism and very see

dose the mostly media Nova is was [stigma] and we and study risk You opportunity PML? extremely of the data Subcu to risk we should really and limited. hopefully prescriber’s TYSABRI on PML, always with tremendous extendedly interval the know, for optimal the the light with of of of an the frequency the because landscape dose generate readout the data of Probably the infusion is shed around and When is it centers? the we a it's enlarge look success, target. treatment. And at because which the it Is TYSABRI, the both.

the combining the dosing. of efficacy are opportunity accessing Here subcutaneous we high with

should and for to use the position TYSABRI. be the in we enlarge So, targeting a

Operator

take Please Meacham Bank next of ahead. question We'll America. our of Geoff go from

Geoff Meacham

Lily be good I We're materials down what imaging factor. the have just in quick guys, Alzheimer’s something you be just if was for real provided Thank did on assess just tau could implemented thanks road details tau, regulator, for to Hey, I and the to just from any to [adu], your that EMBARK Al morning is that wanted more view disease able the question. to guys the sure On And studies? curious think getting wasn't of study. you your the severity, you.

Al Sandrock

we June remain Yeah, additional would for we submitted data Jeff. major PDUFA of affect Hi, obviously track on and had the date that X that. if

comment to PDUFA date. by to we us, them. say with you know, with meetings that submitting want track continue And what for we're, have decision So, to our everything's but to on regular interactions don't that, on a other FDA on than except we the PDUFA

stage BANXXXX. maximally tau the tau, aducanumab right as using if tau the potentially certain, concept with is as disease very from imaging well concept. pet, could terms donanemab at amyloid patients there a Alzheimer's essentially you are would that showed and lowering of such In stage interesting that patients of agent you of potentially pet And benefit they as choose look novel amyloid and an and to

concept. I So, interesting think very a it's

that could I that at study, further it's to something again we with potentially useful. be think and but look something need it's

Operator

Sumant our Please question take ahead. We'll now Canaccord. go Kulkarni last of from

Sumant Kulkarni

taking Good for the morning. question. Thanks

you’re labeling stage thoughts aducanumab, deep in what perhaps Alzheimer's APOEX so latest variables? carrier are on than more genetic by FDA of limitations or your patients, of of adu, and review perhaps status or disease of any Given the other other oriented expectations specific

Mike McDonnell

sensitive types can't Yeah, in could, process. fact wish still review. just to of our And the that I those We're I the middle you questions. review answer I of under I'm know, we're

I discuss to So, with be hope day soon, one to able that all you.

Sumant Kulkarni

you. Thank

Michel Vounatsos

today. to operation We in I for want joining flawless to our on you guidance. and the all Biogen order call on remain thank execution our deliver focused

focused of important in short run, on our also the And with velocity for are decision a important We regulatory we with the good a day. excited are [pipe]. Have critically obviously readouts very aducanumab. and

Operator

you. Thank you concludes Thank call. the That for now participation. your

You may now disconnect.

Biogen (BIIB) 22 Apr 212021 Q1 Earnings call transcript