BIIB - Earnings call transcript Q2 2022

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Operator

Good morning. My name is Katie, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Biogen Second 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. Instructions]. [Operator like call now to turn to would over the Mr. I Head of Hencke, Investor Mike Relations. Mr. begin your may you Hencke, conference.

Michael Hencke

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

the GAAP reconciliation to we begin, section includes in including and measures represent our provided X, we I that X non-GAAP measures everyone a will GAAP tables, go Before and to believe reconciliation financial We a Tables our of the our better X are financial encourage Financials business how related and financial non-GAAP of internally. business today. of and and the the find the to to biogen.com GAAP earnings economics results of release discuss results. to financial reflect Investors Table financial non-GAAP manage we ongoing

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

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

Michel Vounatsos

both execute steps path second our and guidance. and shareholders time. full well you achievements be year believe for thank for financial patients over the value to we and are raising us. quarter, to joining continued everyone, critical creation renewed our morning, to our Biogen drive on Good are We pleased in

Review First, for U.S. accelerated under disease. early pathway Alzheimer's together granted Eisai, the lecanemab, we're in with for Priority approval the

And decision Phase in next FDA expected to January parallel, we X readout by forward year. the upcoming of look fall. X expect We an the in

we Study positive in potential Sage, additional study there We major evidence supports the with was not without PPD quarter SKYLARK performance. supporting data disappointed a come Pursuit trials does together second depression. is The on now to Phase in and recent BIIBXXX focus zuranolone. will controlled discuss a postpartum in disorders. randomized zuranolone in our now four Additionally, I priorities of however, with of reported R&D, believe were call, substantial outlined body depressive near-term positive positive will the the Phase opportunity Mike the innovation, while schizophrenia Priya X significant in review learn our we is we not setbacks, X last study for will our second that positive. in operational and progress of

First, we on rebalance risk focus are see our where we while continuing profile the programs sources our greatest aiming potential pipeline. to the R&D to across also

in For example, SKYLARK to positive of regulatory following the filing the we postpartum zuranolone Study. accelerate depression intend

in believe Alzheimer's that have ALS. and a inhibitor in such an antibody disease positive success BIIBXXX, some we addition, In as XPOX programs we BIIBXXX, anti-tau molecule terminated small R&D lower

base Second, our costs call last we implement on the are on cost execution. order to productivity further our reduction align track measures outlined in with and to revenue focus on maintaining our our while

next begin the BYOOVIZ, referencing market, the markets. first focused growth year. launched our the U.S. encouraged are outside we global launching of SPINRAZA. also by are This Biogen's focus entry business. are we biosimilar launch China, with just driving additional LUCENTIS renewed the opportunities We emerging pursuing we first Third, a early where growth in we U.S. biosimilars into includes on to the on recently key in Fourth, biosimilars U.S. expect BYOOVIZ

second the joint bring more our of Bioepis to more own to in sales have aim expanded pursue we the the geographies. biosimilars an of completion to our business now the as biosimilars interest Samsung on quarter, products With we venture ability patients, in

and We capital continue two the to We advance value allocation our remain EYLEA Parkinson's programs Alectos both ACTEMRA. referencing collaborations in to and Phase entered we during MedRhythms creation and on disease, focused MS we Fifth, which pipeline, biosimilars quarter. with includes into evaluate X new opportunities. and external continue in internal

to quarter returned the shareholders repurchases. also We approximately $XXX share during through million

antibody pleased to which EU We for medication patients U.S. by or a Priority our the follicular and granted approval collaboration potential refractory in for the was CDXXxCDX a with progress the in are for we recently with The of with recently also relapsed Genentech mosunetuzumab, Review FDA, in mosunetuzumab approved lymphoma. forward BLA bispecific look the

the across these potential to R&D addition recent areas have progress time. we in made growth in to over advancements help have drive Our

This to over not portfolio advance continuing to as all build the create a course, sustain deliver will includes disease, of depression and is programs followed all Parkinson's are Of remain the to and the company. hope, diversified the XXXXs. we which other and in time. work why areas late our as Alzheimer's such results, and committed multi-franchise near-term appropriately in and by mid- We taking to pipeline strengths opportunities stroke we of disease balanced we lupus a advantage

in an the the our for shareholders. filed I for our we which to sheet our both progress capabilities, manufacturing Priya or now our in over our patients portfolio, update our call balance X on and R&D. serve includes and programs recent to pipeline, Phase talent, strong will results deliver Our XX turn

Priya Singhal

a continued R&D pipeline. good as and start by to would and Thank Michel, to advance you, thanking like for team diversified everyone. I and Biogen dedication the focus robust morning, we their

new aspects that Review lecanemab Michel toward disease, for advancing believe and we several quarter pursuit the accepted disease therapies was X our fall. of achievements Clarity with Starting this evaluate exciting R&D study under designed BLA are past the prior As with expected build of lecanemab in utilizes assessments of meaningful I the key various progress early Phase X mentioned, Michel has to Alzheimer's balanced results granted function. patients. clinically FDA this readout cognition for upon Phase had the steps Priority study for the Alzheimer's accelerated pathway. Clarity mentioned, and as is Eisai to designed study and AD also approval an continuing to The

Alzheimer's robust AD the different us of Eisai study disease potentially The benefit quality-adjusted Clarity results, disease. mild, may with with outcomes results also compared can of long-term addition domains trial disease. This completed FDA to approval. results should for clinical believe by design, potential the of and timing X.XX, a baseline that individuals XXXX. The the Phase of standard as Japan study, approved, formal alone, the of results in for the U.S., agreed Given clinical allow experience by disease from traditional could average, X.XX the in if this of on with and life file These anti-amyloid results Alzheimer's totality of further on lecanemab. that X cost and of Clarity confirmatory of an in informal to severe into simulation possibly QX allow disease to lecanemab, preliminary end the lecanemab, the removal treated moderate may care, we plans additional X.XX translate first AD of understand care to progression and lecanemab respectively. and Clarity to analysis years to Last years of pending serve suggest this that AD to when estimating quarter, reduction based effect verify amyloid become on published modeling Alzheimer's approval Eisai for EU lecanemab treatment traditional lecanemab, antibody of has analysis standard slower the

molecular and year. Beyond initiate a to tau, BIIBXXX, advance lecanemab, that our modalities. expect where targets this is later This Phase study we includes across we continue biosimilars ASO diversified X targeting pipeline to

and new that depression during of after observed estimated of medical occurring and X the Depression, women year. together been met common to of results each zuranolone, common most treatment signs announce Sage, further day significant need zuranolone complications Phase zuranolone is and SKYLARK Study States hurting The excited X-week positive as very at we SKYLARK the Moving the X, depression. course with of oneself in in in were improvement primary depression are demonstrating date. significant an Postpartum positive needed. zuranolone affecting a reinforces statistically from its of the to XXX,XXX all infant options and key X This Phase Study placebo, with XX. endpoints to This anxiety, pregnancy, the clinical unmet United has postpartum primary to X thoughts compared day secondary day approximately in X area one's postpartum profile or desperately X or mothers where and suicide XX of second endpoint sadness, symptoms XX of endpoint study PPD. in is an the XX milligrams at of a associated neuropsychiatry, are thoughts is with

Drug zuranolone potential are results in now alprazolam, With milligrams. with zuranolone in meeting. potential the of MDD advance the single and lower study results working XX showed CNS Sage Abuse XX filing College and we zuranolone milligrams X the to of at results we milligrams milligrams SKYLARK to the demonstrated Sage milligrams for which recreational was of that study XX and of Dependence on this in half X and milligrams a the as the Problems year. in of X.X complete U.S., expect to Study quarter, Last second also PPD with abuse presented comparable annual hand, alprazolam zuranolone in depressants. compared of regulatory Human users Liability The this of X.X

severity. neuropsychiatry, in Phase zuranolone XX TALLY the Also in to the that to MDD were schizophrenia we events XX were BIIBXXX study of primary reminder, trials PPD BIIBXXX studied meet were did disappointed milligrams. efficacy a between or adverse in the with in mild in doses X As endpoints. not and cognitive arms secondary moderate treatment impairment the associated CIAS, its or Most

efficacy drug program have levels while measures XX-week the functioning, and entire lack Given evaluation we demonstrating primary period, of to the discontinue in expected BIIBXXX the of CIAS. the and during observed decided across consistent cognition secondary exposure

We at are scientific continuing to and data analyze upcoming to plan detailed results present forum. an the

results and of the initiated versus the our we on of and who month, analysis The designed SODX-ALS, placebo, a tofersen X XX-month delayed presented that had was SODX-ALS. initiation a participants strength to tofersen reductions and originally progressive and data measures function, sustained decline XX-month Furthermore, in the of during life. marker results and new initial X-month for from VALOR of new in the in Moving X open-label neuromuscular neurofilament, these tofersen in the and ALS. respiratory tofersen slowed that open-label believe extension treatment injury to genetic VALOR in and Last months to This of Phase observed form slow of originally led in disease controlled a participants rare earlier portfolio. in of encouraging VALOR the We of progression tofersen potential randomized progression start build evaluate upon axonal extension. of robust showed period study who support analysis during across study disease its trends neurodegeneration. placebo study -- reduced further clinical quality tofersen to

updates mutations is engage biological function. with in Denali initiated of LRRKX, an designed we to to By for disorders, movement kinase small we global for of we and the continue disease, a Parkinson's underlying sporadic Parkinson's BIIBXXX LRRKX and estimated the account Therapeutics. result Study familial Phase We implicated with will inhibitor of when are target Parkinson's BIIBXXX, roughly lysosomal and hyperactivation disease. X% in developing appropriate. in disease to In X% these that molecule LUMA pathway are regulators collaboration data, inhibiting LRRKX provide Xb in

administration we worsening have LUMA patients in once to LRRKX without therapeutic people evaluate For more whether Parkinson's daily with believe LRRKX both disease may is clinical pathogenic disease versus Parkinson's can broadly, and a The pathogenic this in study BIIBXXX placebo designed in mutation. potential variant. slow oral without reason, BIIBXXX

BIIBXXX we We objectives course of quarter inhibiting a efforts R&D people also and therapy this we a evaluate in may year By In LIGHTHOUSE sets significantly Parkinson's both pathogenic potential with the disease well patients worldwide the conclusion, alter and treatment There to and areas the Study safety LRRKX, progression. no of disease continue X the our therapeutic in across Phase against approved executed to disease. disease confirmed suffering are the anticipate that deliver to and from have XX LRRKX prioritize programs. slowed our first-in-class roughly later designed initiating efficacy million variant. Parkinson's

insights Michel already As And this an made decisions inflection process both points. from effort. prioritization we scientific driven is will ongoing this several resulting that have be internal mentioned, by and

in mid- has studies best-in-class Alzheimer's Moving anticipate Parkinson's initiation now exciting zuranolone in towards will disease readout over the to and deliver significant areas These include I both late-stage unmet milestones. U.S., to the the therapies pass lupus. of and MDD filings lecanemab the remainder in call Alzheimer's, and opportunity therapeutic Biogen characterized several regulatory of XXXX, to of patients. and first-in-class, by for Phase we need X Mike. the These where to are PPD

Michael McDonnell

and quarter actual year versus the and decrease and was some of of Total Total XXXX revenue million Priya, everyone. highlights TECFIDERA Non-GAAP I $X.XX, diluted was all revenue the increased second U.S. at billion, our Global otherwise noted. update note second for $X.X currency. quarter will you, was of the currency. share the morning, versus our X% of a XXXX, which XX% are X% financial quarter decreased unless Thank the actual in decrease a at at good currency Please revenue currency in of full TECFIDERA comparisons currency guidance. provide $X.X XX% per constant performance of actual and that constant X%. at a X% at to second of billion, prior decrease X% revenue was the quarter. earnings financial second and royalties OCREVUS quarter currency. MS inclusive constant $XXX at for

TECFIDERA monitoring will to of primarily markets TECFIDERA channel in point, Germany. do by several generic closely. Outside XXXX. have decline we the year and as situation throughout U.S. was due to we generic Canada in competition this the and of and U.S., this impacted that aware in However, the dynamics modestly At applications we are approved the be Europe, such was expect

new a at currency may be we XX% increased the were risk. to granted XX% reserve against Global still constant the revenue possible assert and at be of to it's grow the but in and continued EU infringing to in rights patent all U.S. pleased that Importantly, actual currency. $XXX VUMERITY patent million VUMERITY it at

the trajectory. is pleased U.S., launched in are now markets. with the We VUMERITY Outside XX

flat at $XXX and offset volume contract pleased at declines, our suppliers we was and TYSABRI by X% revenue revenue potential U.S., patient to was with Global see by constant currency the continued States, modest currency. actual In Outside working manufacturing supply million United currently the launches. therefore TYSABRI are any of We impacted country negatively favorable pricing. were growth. partially delayed constraints have additional decreased

We are for a referencing the filings and aware FDA that biosimilar to been submitted have both TYSABRI regulatory EMA. the

high XX% upon impacted by the EU, Interferon was approval IP, at our currency in the occur therapies. revenue Interferon U.S. but U.S. $XXX prior in to seasonality continue continued could at shift from decreased XX% dynamics next XX% actual We at and could XX% of at a the will currency, injectable due and platform Versus the to and biosimilar to enforce increased Global primarily channel launch revenue actual and in oral which efficacy or constant quarter, currency year. the million constant

the the timing of decline encouraged Global at markets, revenue certain at quarter. $XXX impacts. versus Moving actual during negative in of U.S. the at SPINRAZA X% and we're dynamics revenue to the negative and U.S. well SMA. and currency, driven and million, revenue XX% U.S., currency at Global of SPINRAZA currency constant pricing the by driven by in the U.S., as and XXXX outside currency dynamics shipments as quarter seasonality impacts the some with fewer the Outside competition XX% discontinuations decreased first competition primarily X% SPINRAZA currency. to declined actual In see constant was currency

X% biosimilars pricing at at Biosimilars constant Moving actual $XXX negative impact increases currency, were more Revenue pressure. to by our currency offset volume million currency. X% business. of than declined increased and

XXXX. biosimilars revenue to expect decrease continue year versus to We full

modest in recorded We launched and stocking. to some quarter channel have due are initial revenue pleased to we U.S., this the BYOOVIZ

with million launch contribution anti-CDXX of more of revenue to XXXX. BYOOVIZ in Total As than declines Revenue was from more RITUXAN meaningful continued we which X%. reminder, expect due $XXX starting competition. decreased royalties XX%, gradual a by revenue a OCREVUS increased biosimilar offset

Now on to the and sheet. expenses balance moving

MedRhythms related related included to This quarter operations of million, Second quarter ADUHELM. compared million the million, $XXX payments. was $XXX $XX second $XXX upfront in in and second payments non-GAAP This in R&D million to the million to Therapeutics. XXXX. including of which expense $XX is Non-GAAP is approximately approximately XXXX, $XX Alectos compared upfront quarter in with million million SG&A was to $XXX including

$XXX Eisai by interest which other Second collaboration includes from million, collaboration profit $XX in quarter GAAP sharing commercialization related million, the million of was primarily $XX million other was net to two partially related with expense income Samsung sharing by which ADUHELM a of of offset Non-GAAP items driven of was profit to the $XX U.S. expense included expense million, Bioepis, $XX expense. of note. reimbursement

gain recorded on joint the an our venture. billion sale stake equity we approximately Bioepis in the Samsung $X.X First, of

addition, conduct subject an tam principle admission agreement fees not plus and to we in and resolve litigation estimated to XXXX. a agreements documents. the recorded is in In of relating This to does expenses, $XXX to final qui of prior agreement million, negotiation settlement any related and liability disclosed previously to principle include

the million make quarter shortly within repurchased months. million. to of $XXX for Free soon we in stock agreements XX second we the Capital from We million. the expect during be after finalized, as which million are $XXX the to quarter, were cash $XXX cash was the $XX generated flow In company's payment possible the million. expenditures next and as shares We common X.X operations. flow expect

inventory building Eisai. over raw months $X we as we inventory June $XX invest in As financial aggregate study capacity, as July, lecanemab to in subject X growing notes negative not with very position We securities procuring XX, in a XXXX, senior debt. undrawn expect billion development marketable inventory If materials sharing quarter in-process also repaid XX, debt, and work in of expense to of note, and principal or Overall, cost expense does the the we to of and our Phase net a facility this on ended receive billion. revolving are to and approval, $X.X regulatory billion the $X related June billion $X.X with Of we an In would utilized strong the September we in continue at financial time due production. including associated $X.X hand business term. cash with billion and lecanemab we is with with million amount significant remain approximately research plan of lecanemab. coming to that cash over the long credit

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

remainder revenue billion of primarily foreign full range range $XX.XX. better-than-expected range of rates, This in increasing billion guidance for $XX increase range to cost remain $XX.XX We $XX.X to $XX previous of is $XX.XX the of the as guidance from to are from previous exchange result full our assumes year billion our our July to a our and year, to effect guidance and new of management. diluted of a activities. hedging increasing will EPS performance year of non-GAAP This that continued $X.X net guidance topline $X.X to XX, billion of a

revenue included headwinds not currency we our in our which some the of year. guidance were Importantly, the despite EPS meaningful are raising and ranges guidance beginning at

continued January EPS July impact of to as April the in $X.XX guidance transact. to as most declines biosimilar to XX. between to in due Specifically, we to fluctuations XX. the revenue predict. currency in XX primarily currency this TECFIDERA a which to guidance approximately due EPS headwinds X, competition $X.XX in is X guidance This due are U.S. May currencies erosion relative and on subsequent of revenue strengthening to a through of TECFIDERA to scenarios approximately experienced million of due for from and These a headwind continued $XXX headwind which revenue addition other the This reflects generic generics fluctuations to issuing April to million RITUXAN the of currency of assumes well we $XX in financial to due EU, dollar and difficult to U.S. range our Further, is recent revenue have entry. to

optimistic share number will our generics of situation. of We throughout the guidance of continue long-term date, us the We business the believe assume on authorization the across to pleased to results of are portion are delivering well we release utilize In raising can and billion the value repurchase small assumptions. a be a opportunities of we core year. financial important of we have $X.X that remainder monitoring for to about and we our execute ahead for focused We and year. our aware remaining the potential create for see summary, that Please guidance shareholders. launched remain are press are

open now questions. will the We call for

Operator

with first Capital. [Operator question of comes the Instructions] Brian line from RBC Abrahams Your

Brian Abrahams

XXX. we a a that maybe this -- you on, XXX noticed little programs, So earlier that discontinuing bit have XXX, and including discussed been and you bit pipeline

on Just assumption pipeline wondering any your change the that, misses bar if on anything if maybe of X to you go for might and approval its to with -- respect your no-go lecanemab primary this could maybe whether study prioritization risk if comment decision endpoint? how Phase on that and reflects philosophy in imply pursue

Michel Vounatsos

give some color. will Priya

Priya Singhal

Thank that question. you, Brian, for

we've embarked focused is But internal mentioned So the we've scientific portfolio. quarter, R&D external well as last disciplined as inflection and of prioritization on points upon a it insights. as dependent very

I is potentiator is is endpoints. we an where in development not from CIAS, the we saw we a cognitive we specifically meet expected the that but And want because did schizophrenia. of which discontinuing BIIBXXX, associated impairment with points amp just exposure, We you readout shared made had about or -- that TALLY up will which that So pharmacological secondary on with be primary up pick BIIBXXX. to

programs carefully, well tested that So really higher very resources we data, success. have it of applications, at with and that other about reconsider we but look to it's believe the to we the probability ensure time here think that allocate the hypothesis

that down we with it. we Neurimmune. that partnership did for Biogen closing it's with are also an BIIBXXX mentioned, So With at addresses antibody that announce question. And anti-tau you development that our

be we post-translational antisense this affects BIIBXXX BIIBXXX, on So forms example, from are I we of our next that will which would questions focusing, is that oligonucleotide trial immune. on ask tau. all you year. to Phase But steps And late-stage, perspective, for new mid-stage X later starting our direct a of further

significant how because endpoint that's statistically trial. versus at what of as results prioritization. that It we So as X to AD extension which being addresses the has, is a finally, Clarity and believe, placebo instrument secondary the lecanemab. along endpoint as address a look meaningful say and just I'll CDR forward presymptomatic difference a think that whole we're Alzheimer's, the open-label well our Sum clinically would be of right all thinking looking and does of the lecanemab, and utilized bar also It primary addition, our program have for that's we with for we're well-designed around we a endpoints. primary subcutaneous. comprehensive And it And to Phase patients maintenance Eisai we in on well-powered, about in Boxes,

So for just think the will I wait we data.

QX As XXXX. it expect we along positive by have filing said, to Clarity AD, be should we with the complete

answers So that I question. the hope

Michel Vounatsos

may of I to and for are delighted and with data ADUHELM. waiting add, filing if leca And progressing zuranolone the also we be more

Priya natural the And always trigger is what is probability pipeline, of have to on our materially it's that and point try this natural select all, -- inherent there risk It's of expanded neuroscience, earlier doing. that inside. we success science For first pipeline. we increase and with and based is

Operator

from Harrison Stanley. We'll take next our with question Morgan Matthew

Matthew Harrison

wanted up follow to just on I lecanemab.

single you p-value that from study lot discussions review feedback in Or is do FDA the a is, So the key going here? necessary a explicit have I've here, regulators been with using issue? be the guess I on the confirmatory that the a getting to around question

Michel Vounatsos

Priya?

Priya Singhal

Thank you, Matthew.

in also, study, expecting So results Phase study, Phase for are the approval just accelerated lecanemab using be X,XXX study. is step study to underrepresented in CMS filing We it's an It's the is similar we analysis. which a XX% about primary XXX will futility the of a Clarity is powered. subjects. has for readout currently, this to which This sometime back, pathway completed X with this study. a interim included. year, fall is the has AD, and or quite -- XXXX. no There X just of is well the the population believe And population It global

approval? whether it regards We a confirmatory with that traditional have this agreement do Now read it for be out it the to study Yes. can can believe study. should confirmatory we positive, be

So what I we believe. do believe that, that is exactly

would an addition, CDR briefing that just aducanumab on FDA document, a inherently statistically they effect. stated the such meaningful remind accept I'll Sum meaningful the a change as of instrument Boxes In us that of clinically significant had as the in evidence

cognition function this we So And it important. right CDR is is of registrational combines validated, that clinically Sum really is is and accepted a It primary Boxes quite confident the endpoint. feel both endpoint. and and widely as

fact So point, at that powered. well feel the we quite are we good it's about that

see the Of the wait to I that course, we hope have results. to answers question.

Operator

We'll Colin take our next question from Bristow with UBS.

Colin Bristow

Congrats on quarter. the

be that given new is reasonable in and to in are after known? could you're And the able the search, to if not time CEO of you trial how you update lecanemab the company within a it that just trajectory, expect And an So outcome important where provide is is until place the to the would us this on CEO a process? just now on line? give question,

Michel Vounatsos

obviously, Board question. the but very at stage, to is for on this that the report. But yet nothing this From Thanks And at the to important I members we'll this week a stage, our But reported. earlier and progressing my it's hear speculate with search be there not as more event. discussion nothing Chairman, is planned. lecanemab,

Operator

with from next Jefferies. our take Michael Yee We'll question

Michael Yee

to then And proposed drug about to market? gets same for commitment and thoughts question investment to for to lecanemab, investment Is zuranolone, around a that that that SG&A that? do works a that as actually around point have reimburse the if whether to into and XX-XX How there works I had and -- secondly, as how think we decision your XXXX? relates spend net is thing. how a

Michael McDonnell

Yes.

So of arrangements those are both XX-XX.

XX-XX. will you and we both to launch those support, expect in we of certainly cases, products, successful both costs that be So share of would building infrastructure hopefully, the

around of midpoint Currently, $X.X managing implies So Eisai we're then, $X.X cost particularly about with we're the that And course, items on those versus Sage committed OpEx. both our to. infrastructure progressing on, and on key commercial that measures billion of very the and year, the we've last beyond. focused XXXX as working a XXXX guidance products well billion very to are relates for planning closely two it

Operator

our Raffat Evercore. with question take Umer We'll next from

Umer Raffat

you subgroup your a carriers data How but that the secondary perhaps intend to primary the submission? like X or active? a ɛX do FDA ADAS-Cog impact if ADCOMS Phase would APOE endpoint work, does like how approach lecanemab not set And or is

Priya Singhal

you, Thank Umer.

is And there say well. that be and So other step endpoints everyone Eisai readout, possible Biogen in could near and we study confirmatory other think at serve are gantenerumab potentially And readouts to endpoint FDA data And for as at a also that we agents And the primary data back would two the is said a is -- term. but that have are be the of the also scenarios that anti-amyloid as attention draw we we other are, other the I in that that on readout have have the obviously, I we scenario, two One I readout looking of these to donanemab, maybe outcome readout. one the end, already, totality the negative. end spectrum, knows. because it's with of a really study. we that obviously, positive the will there secondary I can have as several do And discussed positive -- we agreement the this, will believe important. we with have --

the There So be you some really, how anti-amyloid what -- like readouts to that scenarios, will mentioned, several be think difficult early a mixed about and this very Alzheimer's and these I they mean be in disease. bigger exactly question speculate it for Alzheimer's perceived. could is hypothesis might

So mix there I to the that but data could say would permutation the important. scenario, think I totality the be of is going that several combinations, be

tough outcome But focus ensuring scenario So think of what be on will also readout our allows very speculate currently, fast for engaging, to it have it I at which could with is guidance. all of the track course, us this me would study, this. for clear to that consult the we on close point, because and we And are to. breakthrough what we data, collect mix and lead the be FDA then the FDA a this has and the designation, product considering

you. and I close contact, Thank can will that's be we tell what you. So in

Operator

our Marc from with Securities. take next Goodman We'll SVB question

Marc Goodman

keep key in there? to has just the you there there? What be business? the How us are pipeline can big are sense You the are Just the size where some to us opportunity going products growing growth in a products is growing? give to look in years? we that What X, forward that business of Can yet it how that's to referring this emerging been growth have launch that is markets. X help

Michel Vounatsos

So is this the before provides is element Mike that in epidemiology pretty gives -- West, important mature color, similar the in emerging in more the markets.

of So world. to this our portfolio is part relevant very the

is we even see Middle afford, feasible thought willing and that outset uptake America, to of second able based in have see We in on bit expanded is very is if East, And the is at good the few a Latin opportunities. health with years strongly for co-pay able SPINRAZA. was a in best Pac, the we incident. and the and class these a education since to we the footprint are in that so to Asia of Asia very Pac, portfolio very also our care. far, population, a we access The lower point uptake number very experience that it that MS middle emerging our But see good a

good opportunity. a So

team. professional this but important is We also of a the in world. everywhere, have part Compliance very

Biogen with partnered, we So very to where performance good and Biogen but between have directly a where have we is very is a that date a momentum. secure balance double-digit good we strong Mike?

Michael McDonnell

But base and in as But XXXX as And opportunity around a not huge something being a contributor pleased number particular, on due with a revenue I in to a small to very there's being majority Marc. would China, uptake call gone as the markets the the from In not we been Michael of said, to sit MS other Yes, out, revenue respectable we're pricing years excellent think, growth growing a our I there. overall, SMA. SPINRAZA China, lot would couple of here seeing one that is dynamics say I has well. add, that beyond. Brazil. that's international we're that's

hopeful meaningfully we're can years. to that continue So grow for several it next we the

Operator

Goldman our next We'll take Richter question with Salveen Sachs. from

Salveen Richter

provide on Could us updates of utilization? how could on branding about any you a Schedule IV pricing impact and how thoughts you're thinking zuranolone and potential here

Michel Vounatsos

in the I'm delighted many people. major to and study is had meet We postpartum, disease by so the second many in fourth affecting study depressive opportunities constituency So first, to are we encouraged disorders. see this data. very

it's So mistaken, million as incident every not relevant. said, for in I'm the million, XX year. so to than PPD more X.X U.S., close Priya an If

relevant. So extremely

near on market with understanding the have to and patient in with know session there. we or come segments are opportunity the due We we a that soon to we'll yet hope where to between market have can. back a and the as the side not you and progress in on of efficacy. the the are way that making to naive this of effects as the treatment future, we'll price, the -- and I different dedicated together to an the stand, positioning lot journey we Concerning lack we'll massive update be we of Sage you failure

add some making our are We this nothing homework, stage. but -- to yet at

Priya Singhal

the I you, Salveen. question. scheduling can address Thank

about process of approval if is the robust, DEA that end just So a quite X and say schedule. at they I wanted takes this designate the -- months step will the typically back, will and you process, they to

in At liability X we have, comments. already opening IV study, the also is could get. drug. have data and potential their there has what ZULRESSO, we of is mentioned And Schedule you know as Now do present, human could my completed schedules we which a potentially that I be abuse that background Sage the

a for potential So that and -- abuse low it low for we means Schedule is to do typically zuranolone And possible is it at point, is what IV. believe Schedule IV get this dependence. risk for

drugs category that And currently and this XANAX, is expected Darvocet the we Ativan, in The other believe scheduling. others. are this

Of data we be, we I have but through what have. with to it. at go will that see the to expect moment wait addresses course, the hope the we outcome that's to what the process

Operator

from next our with Securities. take We'll Robyn Karnauskas Truist

Robyn Karnauskas

my voice. losing Sorry, I'm

know goes I outside immunology. derisking the current portfolio maybe that, you've within now pillars question and with you've that and I you think about decision had then pillars, about current also staying maybe lot X was Head would are think the along hire going those talked just So I what your guess about of a neurology make And CEO? to wondering, you months that about it? you the final that R&D thoughts the and given if after of

Priya Singhal

I can question. for started. the Thank get you

at strong just robust. got our vision a stepping -- and And Biogen, and a have multi-franchise pipeline, R&D, we've So is I back, portfolio. diversified we towards believe, quite

We our of have to more the actually we want in with discovery our be to that multiple targets and programs that in look platform diseases clinic, exploratory at the address pathways and and the portfolio, in about think many biological want we may where modalities. leaders we we

as we oligonucleotides have. we gene access therapy. well We to as that's could to antisense the because So strength modality be biologics, agnostic small have molecules, other

a portfolio. how at So level. about R&D we think That's that's our sort of high

is core space neuroscience. This Now a It's within have. absolute about spoke hard would an that, that acknowledge. very you I strength we

think we we Alzheimer's. would atrophy. both as could space with And success with we zuranolone depression. this sclerosis And have acknowledge success with certainly, had multiple well in in have but all of I we've it, spinal potentially, a muscular as lot

about thinking indications looking neuroscience are that got PPD as filing at we and a both the are large focus a we product increasing in GABAA in unmet we've pathway for MDD addresses. for and potentially our that is potential now with So neuropsychiatry zuranolone this where need, high other

really much our just MDD this and zuranolone portfolio two prioritization. So that than important with well and immunology, we're Shifting three over more as we could trials, at specialized PPD, X have to and products. in looking is be Phase really

we BIIBXXX, in UCB, then first-in-class, have our We but could we also also collaboration it and be SLE. biology for grown think our we erythematosus, the with have So X. which best-in-class where for Phase home with Dapi lupus pathway CLE really understand cutaneous And well. the

a There, this That's SPINRAZA. is for have So leaders is our else currently. in which And in where core follow-on and in the with Type within and potentially again, that then we where think finally, portfolio could are just other specialized SMA, BIIBXXX, externally have retain ASO Alzheimer's, else for thinking our understand comprehensive sort discussed SLE are once-a-year and Interferon we focus I'll indications about signature, depression a of indications? say in BIIBXXX, opted X already we neuroscience, be can dosing. leadership potential example, a do with we we CLE. MS we immunology

So could really very that be very, important.

we think as that we MS, to We are inhibitors. BTK accelerating And as much we have can. where of continue

peripheral So we have inhibitor. BTK a

have data make will also and We at the continue a central decisions. emerging and we to BTK inhibitor, look

as readout, a fashion, gives approaching And -- of mentioned, this and The are portfolio. BIIBXXX diversified as that and with call we how I data allocate else flavor and lot do team we how in are R&D [glutamergic] thinking area that would gather very we soon you we digital prioritize? pathway and had have one the our this Michel have portfolio, MedRhythms. example, a a as will that of that we would Beyond our increased mentioned, I the this BIIBXXX of there. made the foray out now for to Similarly, would the that? from is a systematic be we we that entire I we're R&D with we resources it's as doing it. zuranolone, a we've just very focus to we We've well. with therapeutics. also very biosimilars and core what to Biogen a really What So doing altogether hope think this is

Michel Vounatsos

to what the the important together, And in is we neuroscience, to strategic chain, direction clinical in the and have to set understand research, capability. pretty is immuno, key we were throughout for bring Priya. the that within and as specialized in are Priya And you, company where customer very emerging that Thank capabilities to development digital clearly early ago value X from believe years the engagement. today, throughout that well commercialization therapeutics compared diversified said, we biosimilars we us

we addition? XX how a The a opportunity products. with now Board. file Phase new programs And an is and permanent derisk strategy the X have to XX and CEO is of the have in on. this R&D We do revisit started work Obviously, will of together Priya Head in question what to

Operator

JPMorgan. We'll take our Kasimov with Cory next question from

Cory Kasimov

for minute. Alzheimer's a to back Going

do So has for think this recent with data? for of that's initial the they face accelerated any And if pending, X convene NCD ADCOM lecanemab indication the the the on how in the about primarily PDUFA an for given obviously, FDA based the study, importance approval you of Phase January CLARITY and relative application?

Priya Singhal

Thank you, Cory.

mentioned, -- firstly, So approval that you and accelerated step X to date for data, filed to think pathway the I we that the PDUFA the is with Cory, as according first just back, January XXXX. have X, Phase

filing the it first will AD be the what positive readout XXXX. in this approval of the of will year. the communicated has be quarter Clarity by it should traditional will And completed be of Now by end fall -- Eisai for

not information the data do at outcome. matter have for think we -- have do have that there the and will addition, not At In an We advisory the will we that an this the totality moment, be that indication the I indication. moment. of committee

hope I what question. aspects on I addressed that's all can -- your tell I about of the that. you So

Operator

next Olson We'll with take question Jay Oppenheimer. from our

Jay Olson

did you Can consider not endpoints Phase X about other And meet would BIIBXXX indications? BIIBXXX TALLY study why in secondary a or you talk the primary for the trial? in

Priya Singhal

Thank you, Jay. Great question.

can negative schizophrenia. -- positively thereby, impact hypofunction we that's the -- the associated increase and are that very hypothesis NMDA that the And increase was working AMPA we domain readout impairment back, yes, NMDA the impact receptor and to memory with with cognitive hypofunction BIIBXXX. disappointed testing just memory in connectivity step domain potentiation for were synaptic working So

the And the was were hypothesis. we looking forward that So to results.

Of or met course, not endpoints. secondary it has primary

in Now trials, compliance you sometimes neuropsychiatry the and the trial. adherence right during don't have

this have And exposures So PK at readout. carefully the was XX-week very looked such. and a we

-- was very looked expected we duration. -- we through confident trial that, have have throughout quite for at exposures this the quite that where we high have and a So compliant XX-week we feel BIIBXXX highly the --

trial, we So us well-run the pathway hypothesis can have NMDA tested rich well. collected we want that, think in we other extremely a pursue give this how very potentiation we that potentiation have Having said the that to and as leading [glutamergic] AMPA an of data on to was set indications. leads might believe that we neuropsychiatry

So carefully. and will unfortunately, We we replicated. not but trials, yes, data at looking be evaluating carefully, Phase very that this was, is something have that we very are did I that early

very and there XX, trials. in was numbers subject was small patients, Now schizophrenia but duration respectively. the in volunteers One these are was shorter X healthy and other and were XX the

So very small trials.

to our and high-quality look yes, continue this meetings. also So we'll set, data this capabilities and in medical it at and remains presenting your increased focus We we've very focus. believe question, area, neuropsychiatry we'll upcoming at to area high of be an

Operator

Phil take next from We'll with question Cowen. Nadeau our

Philip Nadeau

it at timing after to feel question approval, be but full about launch specifically another an or the Mike, be Biogen to up What follow there's some accelerated would step product? Cory's does resources come within it infrastructure Would A behind likely putting of build Mike. the NCD like how after and true at lecanemab directed point. of does seem approval launch? now

So commercial the when would program? Biogen for feel infrastructure comfortable in really investing in this

Michel Vounatsos

suddenly and work to first are the a with filing launch, close we that and of say during to global XXXX. in and like partners Eisai our collaboration not would I we that place U.S. in, jumps Mike half a we EMA launch, before take So in at anticipate approaching Japan the full

And a an approval approval that. So we is global as this potentially a full know, there be accelerated and sequential a here obviously, will after Mike? between launch. process

Michael McDonnell

Yes.

Phase just early covered but say date the I in Phil, readout and question, lot of in terms fall of III Eisai PDUFA of 'XX. we the of is think it in a that lecanemab reminder, The a XXXX. would for Michel January the I as that expect

antibodies -- currently know limit you the significantly the market accelerated with does determination coverage written, for opportunity as As national approval.

Eisai very we as necessary too can as infrastructure it gradual think we'll that's take felt each we say and something resource decision. would a timing Eisai commercialization launched. And ready. to rebuild in right with when align need we learnings and the as that with we're closely its take quickly decision make appropriately. at ADUHELM resource we And of like very commercial of ADUHELM on. so lecanemab fairly we We feel fashion can, from obviously, was is again, I'd was gradually time And as Michel we'll where when closely said, the large because down to that, more gap will the We'll the lecanemab. partner that infrastructure the the to did phase and we for I that, it

Michel Vounatsos

quality think correlated data. cognitive of believe. a without ambiguity we decline I clarifies the plaque it a is very If removing of than what that on arrows will the be and with and any the that confirms I the with slowing line reinforces the data much think dependent faster hypothesis, down the

Michael McDonnell

thing Yes. question purely And ties an the is asked standpoint, it the that Mike from other and Yee accounting bit earlier. back little this here, to remember to a

item costs, of one-line lecanemab. for will as our the everything revenue revenue aggregated a reminder, share a reflected and XX% will be as all be Just

Operator

We'll take with Geoff our America. of next from question Meacham Bank

Geoff Meacham

lecanemab. previous Just some to on questions want follow up on

to wasn't just on how U.S. regulators or discussion you were you some a about but give your talked of risk/benefit with had able the if have guys Japanese insight already, EU much ADU discussions from bar? I You there. the prior sure opportunity have

Priya Singhal

you, Thank Geoff.

that in the of communicated So that -- previously have of been have Eisai be QX Japan, Europe line. This well positive. similar Clarity they In with been should that consultation. be the process. communication, completing we regulators around in Japan as will they they the line has very XXXX, AD actually in both in by is, post in And as world, part its are readout the to of communicated line consultation the communications and Eisai filing with time has end they course, all have communicated prior U.S.

should process, expedite Japan to be in the Now the prior the positive. really review ability process data the consultation has

taking also place. that's So

and on Benefit risk the us the designed instrument. the always all everything to drive clinically a give -- will answer and discussions, that on track trial submission. So complete to validated well-powered an the is we set is believe up well

rest -- the on We, we of believe up data. well. is course set will So depend that it the

Operator

Evan We'll take our of Seigerman question next with from Montreal. Bank

Evan Seigerman

to potentially But see from the AD think CMS know trial ahead on revise Clarity call. I'm that I Medicare looking the Just discussion to the to of do a lot needs you up NCD? what to that is essentially population. in access trial, the there's wondering, open sufficient

Priya Singhal

Thank Evan. you,

we data of studies before -- this to important that approved be of that may -- reiterate kind final antibodies that would covered in kind indicated be answer with for it prospective CMS be So I that the us directly, approval a full NCD registry. think I that collected comparative could and but before in

initial designs study may good point depend is to these of randomized which trial controlled good This designed is on well because and Now trial give that powered that that evidence is what the degree approval. feel a FDA made, on there we the set led about well interpretation aspect, the us quite we and left to they part well of open strength next in here readout. to think rigor up that the is of

a CMS forward we full potentially that from has chance would Clarity is if that level forward would coverage. -- reads the they it that trial positive, that bar the that the high meet put NCD there of evidence be that NCD in out So could put the that believe has AD and reconsider for

the level consider of at of to designate looks that are is two frame, aspect and what how coming there high CMS evidence. influence also readouts sort a other as same in The their here they which could guidance time other

but it's my So us this this. Phase depend it on at clear will point, data is molecule, personal X to not on interpretation each

a design, CMS in Clarity Now believe the has the memo. set of could they level robust as it that Eisai forth NCD evidence announced, meet high and by has

of do under evidence high mirrors think that CMS it population to that could the safety, I represented population. efficacy reconsidered. include level would be have think the So And we

In the dissimilar would and Clarity CMS comorbidities that say population from also the addition, not medications has concomitant in I very population. the AD

I So bode up things set think well. these and us well they

think depend final will data. on I outcome the

Michel Vounatsos

also and subcutaneous There what a to that is underway. design, the has extension the to opportunities there add beyond with new ongoing will management trial Priya And for an is life preclinical add said, also information. population earlier solid open-label cycle some formulation

Michael Hencke

our conclude for that everyone, Thank And you, will today. call us. joining

Operator

conclude will That participation. appreciate We your call. today's

disconnect. You may now

Biogen (BIIB) 20 Jul 222022 Q2 Earnings call transcript