BIIB - Earnings call transcript Q1 2022

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Operator

Good morning. My name is Cecilia and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen First Quarter 2022 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise [Operator Instructions]. Thank you. to conference like to now would turn over the Mr. I Head of Hencke, Investor Mike Relations. Mr. begin your may you Hencke, conference.

Michael Hencke

Good Biogen's Earnings First you. Quarter Thank morning, XXXX Call. and welcome to

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

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

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

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

Michel Vounatsos

for Good Mike. joining thank morning, us. you, everyone, you Thank and

focus our performance R&D, Priya priorities. operational execute Mike objectives strategy will our We and and in quarterly on on I near-term continue the and business in core progress while recent quarter. to review our first

the ADUHELM. disease. few decision by effectively Medicare all Let comments coverage Alzheimer's beta to amyloid denies recent me determination start beneficiaries This targeted therapies for with national a for access CMS on

ADUHELM. commercial disappointed NCD. will very We And by our for result, eliminate a are infrastructure substantially we final the as

to U.S. resources continued for minimal including the We manage program will patients currently free a retain drug in programs, patients treatment access on

funding the continuation of and We our activities IV initiation to study regulatory ENVISION. of for continue Phase R&D study expect certain post-marketing our redosing the requirement and EMBARK ADUHELM, including

data be regarding antibodies as actions FDA potential ADUHELM and Eisai by may the committed engagement this closely In upcoming lecanemab. are of with informed with on expected further as class for readouts CMS. to well parallel, we launch of working Additional the

are number DTNF TECFIDERA, Biogen in We of in are the of business on our now and zuranolone, challenges, including is shareholders. in facing forward including a U.S. generic near-term all [ph] interest to execute biopharmaceutical such the broader biosimilars base looking lecanemab disease biosimilars the recognize advance our best launches SPINRAZA for cycle, We as that to XXXXs we capital and, and the company over our share profit lecanemab, deploy for well. we we and business opportunities course, the potential part will business development product such lupus Parkinson's can of other areas and and help stroke, growth of potential the see as return new in mid-to-late we life and pursuing new Further, additional believe from of as declining challenges. work challenges be driver zuranolone time. pipeline, and a additional grow These RITUXAN in as These that competition erosion

the is company's product provide there visibility better future. we long However, given CMS light recognize more and today that the we cycle are of clarity into we to must do decision, business and in in a

actions priority implementing the now. share me we are Let

will which Approval Priya Accelerated the rolling be the Alzheimer's This data in will the are In by second maximizing First, we under Eisai, prioritization XXXX. submission focus disease, plan part complete of with the year. our to U.S. this quarter we R&D in of in expected Pathway for of discuss. during prioritization process on together readouts probability lecanemab informed the key with increasing the goal further success,

are Based we study, for by to plan full recently rolling to new of MDD results addition, U.S. fall. trial and expect first full of In disease approval expect opportunity potential of the submission the anti-amyloid an In and with zuranolone first zuranolone for filing the important a complete option readout for on the we of the AD, of to XXXX. Alzheimer's with We second Sage half for CLARITY submit III for this in working the FDA in the as initiated XXXX the the this obtain lecanemab Phase neuropsychiatry, approval advance become to quarter lecanemab MDD in complementary to antibody the we PPD.

mid-XXXX. the III forward mid filing Phase Phase year. PPD, for schizophrenia II study associated with year anticipated also look with in early neuropsychiatry, this PPD SKYLARK expected cognitive impairment next in for in readout associated in to readout We we the Also expect BIIBXXX an

beyond implement and reduction infrastructure These the previously commercial elimination as communicated to and continue we pipeline measures other costs ADUHELM base. include reduction commercial productivity fund our of as revenue our align supporting our while will promising and additional we to will our with opportunities. cost above Second, substantial further cost measures initiatives well

in in to business, certain products -- a in includes and we East. as our its and term, Both in have America development, the in half. such growth Bioepis, emerging in to on of Third, China opportunities. may near referencing NTMS launch portfolio peak the This include business SPINRAZA biosimilars Latin our drive we of life on renewed LUCENTIS growth and key are more launch U.S. currently of coming focus executing plan past with cycle. continued are markets development pursuing international preparing We local the and Middle slightly although both the also the we the four opportunities markets, programs

debt, flow and fifth well priority fortunate balance billion the capital net as of a Our strong of Biogen is with modest is as cash $X.X in have near-term end sheet strong to allocation. as cash the quarter generation.

initiatives challenges faced -- the towards incremental by growth focus cash repurchases. been to months cash while create revenue XX the the we summary, significant. company to share continue designed to through forward, the Going the have over last opportunities shareholders In continuing to return plan deployment past of to

committed all of and, taking capabilities, portfolio, our have, expected pipeline, from includes course, advantage our our commercial the balance of Phase are to our manufacturing that we XX strengths our to us. filed performance which including talent, sheet the We in III is strong deliver on programs

been promise proud me achieved. of thank such I colleagues. dedicated time want have call period. Let colleagues for to a smooth so transition. to I my we R&D. Priya with on for an the has I during at an this and their lead Directors turn this progress value look Biogen support for work challenging will with for and all to a talented that potential noteworthy Board now during forward outstanding of working successor that I time many will period be saying a of closely over the creation, by honor company conclude update in it leaving with of am through and I recent my very and to our

Priya Singhal

everyone. good you, Thank and morning, Michel,

on Biogen's portfolio. a with sustainable deliver are we As Michel the vision our that on mentioned, focus goal pipeline can ensuring dynamic prioritization a of R&D of enhancing multi-franchise

areas profile disciplined in be adjacencies. select different core including invest emerging by well encompassing to neuroscience pursuing within therapeutic well approach external therapeutic in investments with as scientific our a and new manner, data, internal and informed those opportunities in readouts. a R&D external This We as continue risk/reward will potentially as will as

programs. partner we accelerate, As strategy, certain or part terminate, divest to of choose our may overall prioritization

and In outcome will R&D positive increase the modalities, of clinical being concept. genomics, addition, will we continue share to measures. functional of novel advance goal in The proof I capabilities key probability now success accelerate reduce development risk, biomarkers disease. Alzheimer's such to Starting as the of with clinical quarter. the highlights patient identification, achieving and

which the than less less of allow disease to Eisai X forward injections rating XX% a study. filing with a of are and Phase open-label SUVR in increase Xb with extension, plasma defining extension that a Furthermore, at to lecanemab Alzheimer's prematurely with Eisai presented through tau people two March study clinical addition CLARITY benefit compared study, discontinuation information and subcutaneous from ARIA was dementia amyloid meeting may in on safety rate Phase end biomarkers the per gradually biomarker the biomarkers lecanemab X%, in back Phase baseline Notably, changes correlated will showing pathology, evaluate participants by treatment study. annual where re-accumulation receiving changes of and kg the that with initiated of IIb was study and open-label a infusions. reduction in amyloid CLARITY these ARIA-E sub-study observed Sum the the lecanemab core were to biweekly peripheral ongoing preclinical in in treatment lecanemab Alzheimer's Eisai of continuing lecanemab AHEAD the specifically is in and ratio presented of the upon of plasma dosing This scale, decrease the of IV respectively. subcutaneous We incidence Biogen the in study, impairment, than the data look the included currently XX-milligram XXX however, In clinical as XXX, core ABNXX This of disease phospho-tau reduction ARIA prior and addition important peripheral past the brain core also Phase X the in progress suggesting time-dependent and ARIA-E resulted XX the efficacy these [ph] stopping cognitive or measured amyloid to pathology. which this the U.S. to evaluating to further reverse Boxes. of change additional as in an symptomatic evaluating AD larger assessed at began by to brain dose AD ADPD co-related lecanemab was study. in in dosing of consistent that PET of the and from XXXX. with lecanemab

to slow O-GlcNAcase tau tau OGA, molecule of treatments tau or an BIIBXXX I of to of study the lecanemab, catalyze a potentially small of thereby we inhibitor across O-GlcNAc oglicmulation ASO, inhibit aim and believed post-translational includes protein. modification Beyond BIIBXXX. new actively removal pursue disease. enzyme the of increase II in and to the our tau decline. initiation molecular clinical inhibiting aggregation Phase BIIBXXX, the continues This for is of Biogen targets By in planning to OGA, Alzheimer's of the Phase study dosing

to our EMBARK As post-marketing ENVISION. towards of working initiation we are Michel in requirement aducanumab, data and study IV the ADUHELM Phase also mentioned, with continuing redosing collect study

initiated to drug Biogen application neuropsychiatry. rolling of to the that MDD. we FDA in submission for the and recently Moving zuranolone announced a Sage new

well symptoms trial primary to co-initiated Top zuranolone assess this designed response in Rating who the ADT the placebo resulted placebo significant co-initiated period Zuranolone the a versus ADT. point and study care endpoint. with treatment endpoint X, at day and endpoint was controlled most filing from that trials of antidepressant line to X-week the III excited also primary the as complete is well with as showed were full to We that from well compared as a in of the change Hamilton a depressive Scale. MDD. We large blinded XX-item has the expect earliest time measured, naturalistic by SHORELINE CORAL disorder ADT, with as over events to the major adverse statistically was rapidity moderate. co-initiated reduction announce an the ADT with in initiated depressive randomized baseline zuranalone important reported study study, standard in In measured in as Phase now year. secondary randomized repeat half with CORAL as zuranolone MDD, key generally mild to four delivered insights second met milligrams The of XX prospective on in results total, study treatment the tolerated on positive when as Depression treatment-emergent or open-label zuranolone

treatment with antidepressants, While these consistent questions, from midyear from consistent reduction ideation; a study standard zuranolone look rate to an PPD and depressive treatment III with to address is forward gain, early profile year. to with positive depression. we due PPD Phase bringing postpartum next to optionality symptoms by to suicidal forward designed suffering of and well-tolerated course rapid see associated filing anticipated of observed mechanism of study action oral dysfunction potentially and We a that in different profile data sustained look HCPs III low a tolerability were a SKYLARK readout to that Phase in compared a patients. as care in may the a events ROBIN provide taken and for short rapid This of needed; zuranolone adverse patients can depression. sexual that includes be in potentially the expected of a addition onset, the effects weight without new discontinuation to antidepressant trials to We approach or flexible

measures ALS. We did primary exploratory the in start Phase multiple for with the significant endpoint Long-term function, open-label June. and from genetic data ENCALS study to life Phase observe who VALOR. follow-up achieve the interim change across least at includes of Moving extension form of present survival of while SODX previously new upcoming the a ALS, tofersen the be the of versus VALOR for a ongoing presented. VALOR signs of on III analysis from meeting week study disease on not year reported one progression from will We quality integrated and data at to ALS, the ALSFRS-R This statistically plan participants at secondary in reduced had a of its placebo. of and III opportunity rare of We strength, that data analysis SODX-ALS XX endpoints. did interim

also continue the also in people approximately tofersen Program, from global participants with Access a Toferson to for mutation, confirmed a than which while to supporting countries. date XXX We SODX-ALS recruit dozen with includes presymptomatic more study evaluating a SODX Expanded ATLAS,

We for steps regulators engaged tofersen. also potential with next remain on

erythematosus, to an to milestones of with to or In for Biogen actions the advance study taking program. in we late-stage of Phase significant for pivotal with will contains we total a steps As are planning suffering see, clinical disease, several that both in a call summary, I patients believe addition diseases Parkinson's pass in that now enable molecules late-stage key stroke filings, diversified and III disease of Phase neuropsychiatry, Alzheimer's to well X continue is pipeline from a Mike. first-in-class in you potential important XX as to and ongoing readouts SLE, include initiation in with either year regulatory important programs recruitment III lupus expected of as number a cutaneous XX filed. in for need. mid- next the milestones These programs BIBXXX delivery studies XXXX programs will can R&D over starting and best-in-class unmet we as lupus being

Mike McDonnell

Thank review unless performance good comparisons note otherwise full revenue everyone. that year you, for the around will some the XXXX financial I Priya, versus first the quarter provide and noted. Please financial and are morning, key year, for Total our highlights quarter guidance. billion. prior all the was $X.X

business TECFIDERA global impacted MS inclusive the revenue. OCREVUS of entry was royalties pressure generic the billion Our and $XXX $X.X U.S. pricing million. first be of revenue by impacted to outside by in VUMERITY quarter negatively continues in delivered U.S. was

the were TYSABRI towards VUMERITY's trajectory up In with the are pleased are X%. launching injectable patient revenue continued growth. XX U.S., global to the modest markets pleased TYSABRI from offset therapies. in oral the to platforms good in favorable U.S. efficacy declines. see than progress this the high outside U.S., due U.S. year. We pricing or and declined shift by Interferon XX% from revenue we revenue making to the Outside benefited increased global more that to volume continued

SPINRAZA discontinuations over SMA. at full to sequential now levels X U.S. decline grew some in receiving driven channel revenue by SPINRAZA primarily was revenue XXXX, were negative although quarter. in starts certain currency revenue driven in by U.S. a markets, of competition the the positive X%. quarter the partially uptake of new global and see dynamics QX U.S., as versus In national versus to growth driven the prior U.S., China slowdown declined the patient the encouraged offset reimbursement revenue was strong by outside since this of seasonality China. X% highest initial by shipments Outside of first performance impacts, as in solid in Global continued dynamics, Moving we XX% the years the and as was timing the well

to declined Moving X%. business, revenue biosimilars our

this venture. In joint currency biosimilar April, completed by offset stake sell pricing While than equity the our pressure our volume increased, and transaction more negative impacts. in was to we

the anti-TNF ophthalmology As reminder, unchanged. be for a programs substantially will economics and

the In months. launch preparing Bioepis addition, the are in U.S. we to coming

XXXX. a due Total versus gradual revenue expect in in increased pricing to to competition. contribution revenue expect starting by prior to We royalties full offset partially anti-CDXX meaningful the revenue launch Europe. continued Overall, being biosimilars in year revenues due more decrease with RITUXAN pressure biosimilar year grew with X% we OCREVUS decline a

impacted million by million reflected collaboration capacity these margin charges. First is of share in was sharing line. negatively inventory $XX profit Note as approximately $XXX charge quarter idle charges write-offs, as that for well a of gross the Eisai's ADUHELM

expenses was profit share million, SG&A was also balance sheet. of to $XXX the ADUHELM. costs to reflected these sharing the Eisai's approximately $XXX million. including in $XX expense now and related R&D QX Moving are non-GAAP collaboration million line. Non-GAAP

reduced collaboration sharing cash to $XX were Samsung of also $XX reimbursement JV negatively net first from Bioepis. of related net of debt, partially the and debt. to by the which the sale million. flow generated million, $X.X timing from quarter approximately and our profit was billion expense We We flow billion quarter, marketable securities, with Biologics. of by million quarter free $X we our approximately approximately payments. includes ended billion Eisai, sharing approximately million Capital million cash Samsung $XXX impacted and operations, $X.X by received certain profit subsequently $X.X offset expenditures net billion First in million equity in $XXX which from $XXX with in $XXX the our operating In was cash in collaboration expense

of as term. long the in with in significant business financial end undrawn we very strong revolving quarter. and remain the to over the $X cash credit a Overall, position growing was capacity invest our Additionally, billion financial the facility of

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

reaffirming U.S. X strengthening are from of April $XXX $XX an the full hedging January to This net resulting guidance the billion. our activities. in dollar revenue estimated year through headwind approximately We reflects billion of of million, revenue currency $X.X of guidance XX,

non-GAAP to guidance $X.XX We are of that of well EPS of strengthening diluted of $XX, the also year mentioned. inventory an despite as I the just ADUHELM reaffirming full dollar related our impact approximately impact write-off to $X.XX the $XX.XX

due announced Although of revenue erosion cost offset the write-offs our competition RITUXAN guidance today as to generics of better This the the as base financial inventory believe the in business as the in well largely to prior U.S. our quarter due the not continued This impacts. entry. biosimilar assume can currency also potential continued either TECFIDERA entry well measures as headwinds, revenue these TECFIDERA continues to guidance generic in assumes we did in the or performance EU in additional of guidance XXXX. second assume declines

yield be coming addition in savings initiatives to expect annualized measures, to when reduce are from as portion inventory already ADUHELM to We gross the will initiatives these compared implementation the Michel which to decrease additional reduction targeting productivity cost billion, years. products our These savings. total expected million well charges expected This reinvested with discussed. high-margin This annualized $X additional guidance in savings communicated previously reflects strategic the which margin to in the as over in XXXX. revenue brings $XXX of the initial approximately approximately measures million a and annualized $XXX percentage of approximately

April between guidance. previous to R&D is the $X.X billion mentioned, SG&A guidance remaining impact which will see billion our assumptions. expense be prior and year. expected repurchase $X.X authorization net is of This non-GAAP and expect of as year, a rates reduction exchange effect just to strengthening additional billion, remainder primarily Please utilize quarters. we for portion activities other assume share $X.X of does a will for $X.X Non-GAAP the guidance fourth our of is year. the of due important the throughout further $X.X which third press $X.X hedging of measures $X.X decrease weakening unchanged expense throughout We be foreign that billion, the and XX contemplate remain the which from expect any billion between is we from and We assumes billion cost to that in release billion, of the to dollar or to which the guidance not

now business can we near-term We'll on summary, call the now priorities, continue creation in are value So drive of operational a to open our quarter this execute questions. set for time. focused believe objectives over core which on and we

Operator

question Please first comes Your Matthew Harrison Morgan go Stanley. from line from Instructions] [Operator the of ahead.

Matthew Harrison

taking is the could the for of Board looking hoping was in Great. Michel, wishing what Thank you. for the here the best well terms on timing Good terms comment thanks transition of as in the CEO transition. as all the in I morning, question. successor, and you you

Michel Vounatsos

X.X every Matthew. despite this Thank priority guidance. the during and that Today, it was the as and you, had. term momentum our transition good team approximately I've as look facing. years history, is as a to the and reaffirmed you we so so a key given to can we a events I my if going we tenure I've could posting do support cycle will deliver. to competition continue at is professional lot, The continue life are that that well the the business in

We ADU anti-amyloid are is the unfolding. still come. the to about about story and excited readouts the exciting -- And

And continue. everything heard, will that will opportunity decisions. about new very we've have excited to the best space story the in including So I'm that inform readouts

while So think good CEO It's have and assumptions. have the event. very pretty years, that company basically who in with somebody Phase and a with you an important the timing? else biosimilars transition to support of the one specialized of after III health, to I assets the But is ideal a with not a strategy comes some the I'm we that is there the X.X stage And always is and well is that in I the are digital think company revisit at immuno all positioned. being Board natural neuroscience visible sure.

coming on the the my continues. It's team that about good Business transition. me. with Boston and in be future everyone potential in also. end and person team on Asia It's partners our week So be the in key and team for my And to the and York. PMDA will our meeting days will the be of company. a I meet company, I support I the smooth meet be think of traveling about and involved. at again all will partners with this on not you in focus New will

will So continues, I at the top it last business the of the and be until second.

Operator

will take question from Raffat Evercore. from now Umer We our next

Umer Raffat

way Thanks so question. much because Hi at sorry, what in had guess I'm on get is $X SG&A guess for we SG&A the I next you OpEx taking a the Or back you simple to just leader MS, are were my cost guys. trying medium -- headed to was when I'll overall Biogen, And confused term? but second. partially but was truly billion to guidance is focus unchanged. Because the the just think I maybe where cut, a over actual $X a was just on first about think for only but MS I marketed cost over in was started coming savings? SG&A it guidance cut, covering I'm revenues, I billion.

business? X.X the have I'm goes saying much. can necessarily of and see substantial SG&A market the some you is we is very you And SG&A little a the Thank but meaning revenue billion, higher. of billion, And rebasing down to billion. $X.X Now $X not $X MS course, But biosimilars SPINRAZA. a

Mike McDonnell

Yes, question. you Umer, for the Thank it's Mike.

run savings the XXXX. that that call million infrastructure. tied And additional million today, mentioned had ADUHELM a our So number initially we $XXX about rate will the in about be to that expected on talked $XXX last we we that cost the largely

be substantially. will obviously, so And that cut

took about we in that million, is it. guide piece a So the $XXX where of largely significant by down SG&A that

well able a result and things. better remarks, return of expected will currency our the the being and G&A the a with rate. portions SPINRAZA growth. prepared that write-offs initiatives, year. has And say Beyond And achieve as obviously run had cost top we that the and that we would was stronger half initiatives we originally to said bit others that headwinds in revenue. of future was notwithstanding what to that, MS pieces really that and relates EPS of facing. It's we two into the will may order the growth look we've bit little to guidance, and and into as in of being priority overall our certain closing non-revenue at in million I savings the we then contribute And hold reaffirm to to the in inventory $XXX the invest to some expected, at that were as the little place. than is impact than line half performed cost savings ability -- facing guidance, One point as second the beginning between that I about in it were that the the CDXXs the the a to in to same our

color. business. So hopefully, take trajectory to of cost necessary helpful that's we'll to align measures And revenue with the continue the some

Michel Vounatsos

Umer. a couple And comments of to consider,

and DMTs one few SMA, And the very being each in mostly is leader to extremely it Europe. where the class, now and case were business U.S. is was at The those in NTMS first and that second still not Biogen today. one it's being MS of is crowded globally being And this is time the the there that cover, in you started only. that point

on means engaging, have of eliminating. but So we and terms made and ADUHELM we're skills. using in muscles the compounded this this get that of obviously, we all is progress digitalization investment tremendous And made takes point, and, have we the some by the

Operator

Please go from will Securities. Karnauskas from our now We Truist take next Robyn question ahead.

Robyn Karnauskas

question. Hi, thanks for taking the

first the is one just Priya. So, for

how why you more could in referring any think there's lecanemab. you to. about mechanism Can showing data elaborate And know new that versus products. about a that it you think updates wanted suggests did stop talk potentially have you're to decline you You difference on divesting talk in Another if you Thank some it, mentioned, I as When you mention could the is? just you thing cognition. what you Lilly's to also if you. drug? about

Michel Vounatsos

Priya?

Priya Singhal

that for question. you Thank Yes.

first So lecanemab. touch let upon all, of me

I think is from the that that it what the that's the I treatment the what this. of need And II to gap data away science was that ideal is from on label, the duration of shows by we think which is open followed this period in is study. take point the aspect kind really And referred you data I in extension the Phase open-label emerging. to that the

XX So well in XXX. the in field to we direction. the saw as both wrong And is as evolving. ratio, XX There reversal plasma were [ph] biomarkers two phospho-tau a AB in

we So are maintenance how be this are are the I II on doing applied, think in in to address it is trying can they open-label taking this how -- their assessing actually a and Eisai they extension lead study. because is Phase that

So as the asked there's that I domain. more the upcoming follow-up. the seen in public of period for data you is probably that I've a data And learn haven't And me they the in that long-term to what seen I will with donanemab, effects more. I think out think read only speak comparison, we can after

I that can once the to see, Eisai happens And cause what what would we that We and us to happens At think for fair what effect along seen is be lecanemab stopping plaques, data amyloid similar think stopped. of a we a believe, phospo-tau prematurely that, of haven't what relevant to I a with comparison. make reversal. moment, is

do I R&D question. integrated that mean entire we expertise, are areas, we stewards just your we of hopefully, lot then prioritization. the looking of we're that the part was of we're we're are that question therapeutic second our looking and and leaders, disease portfolio, about accordingly I looking step divestiture. looking What internal where And answers areas, are on that our I'll of at at mean we our this? And back our prioritizing good where portfolio, making across decisions being resources. a have by say and at So part and

part in internal driven also and is this readouts. by So external

cognitive for readout just impairment for which zuranolone. schizophrenia. BIIBXXX, This associated and in exciting step a expecting For example, we filed we've for an us upcoming with very are is for is neuropsychiatry

what where have around lupus. to shows we we and see have areas. we we'll will But goes that anchor areas same expertise those So readout The success, build again, us. for

indications. three and data. may build also areas those see expansion as and of We continue we in to consider programs will lupus We out readouts have we

So integrated the very everything on about methodology. and be we're is table an disciplined to trying really and prioritization

that I may have within they -- or divest. Now have is them. integrated This by we that prioritization, utilized assets be partnering we them where by meant what better believe externalizing by may

strategy. addresses Thank that one It's part a R&D larger, much it. just hopefully, you. integrated synchronized, of So

Michel Vounatsos

next the please. take we’ll Operator, question

having to We’re call. try difficulties, technical the Difficulty] [Technical rejoin we’ll

Operator

you, sir. Thank

next Sachs. We question will Richter now go our from Salveen take from ahead. Please Goldman

Salveen Richter

Good my for taking morning, question. thanks

is growth, capital of how strategy In terms much to of drive priority a development? your allocation business

Mike McDonnell

development Salveen, hi, good to the been we has in same very past. priority. have to feel the much Mike we for Business pipeline will the look to about, McDonnell, return and and And development have continues will we And transactions shareholders. question. thank and to at done you be continue we through time, our capital that we as continue that to supplement business a

has be balance development to business a be continue will continue will a and and been priority. to it So

Operator

take go now will question from ahead. Michael We Jefferies. Please Yee from our next

Michael Yee

Thank you.

around the the you you clarify Priya's always table and lines the you terms anything concept consider comments that safe R&D on including just bringing so all even Michel table it on and anything portfolio divesting, out-licensing, on that? on partnering, Can table? to product up but prioritization. with portfolio that is regards is Thank in stuff, whole say would franchises the in Is or the much. to Following of at

Priya Singhal

would science high integration maximizing that diseases to you, by the patients we driven we bring value going and Michael. I with say are and board, be Yes, of unmet to across the that Thank need.

So I the driver, and the would would evaluate evaluations. do I think we think But how all the be we to that's science has options.

said. So yes, exactly as you

Michael Yee

you commercialization and as businesses well? Would franchises include

Michel Vounatsos

some, for for Potentially but not all.

look will a governance for company. the others. the of with Biogen we'll determine and open of But to on on the few support to the that priorities, it's team think I hand remain the partnering upper Priya for be on but

Operator

take We from next go will JPMorgan. Please from our now question Kasimov Cory ahead.

Cory Kasimov

it And ADUHELM's I'm for infrastructure, guys. significantly is say, morning, question. taking lines, is you than to what commercialization remind back too be anything, Or your on simply successful lecanemab wait the those CLARITY about Thanks for different scaling you. for you front data? the III approval commercial is if in Phase your expectations curious, any Good of get along might even long can if AD? responsibilities us full how Thank lecanemab ADUHELM? that until with

Michel Vounatsos

time. we such III details alignment make no in are long based a timing lecanemab. in the Phase long large the will this sense with year. And we do carry such it team, partner a fall But for beyond the full such discussing team the operational So a to of on readout a expect

is So The for many not and keep infrastructure right forward. on is made team, a big preparation the decision. But it's certainly for the afford I there, entire could think months. benefit we class was the moving unfortunately, there the that to that

it's So right I the think decision.

clear. change, just Our sentiment to not for be lecanemab does

Operator

take go will SVB. Goodman now We our next from Please from Marc question ahead.

Marc Goodman

morning. good Yes,

continue topic. on the with Just R&D to

the the factor way has that and that from always CNS. not high that kind and much view all of the has of reward, to CNS bit do really pipeline do start going context just that the pipeline been you. think outside take if mostly, of I little And this stay do within is that And and this management on? that's a going how board now change, away more understand does think viewing how lower diversify projects? change to CNS? you projects how world of change been probably because to you high probability you're you're there's risk risk, I whether how surprising the going much at the look a And is change, things, question. into supportive success to you a the But given change also the you you're from Thank

Michel Vounatsos

about And That know we absolutely. Priya of important very And having say think rebalancing And that. priorities this It's right profile the the more. a risk portfolio. I all question. the somehow it's neuroscience. will and Yes, goes with

Priya Singhal

pertinent Marc. Yes. question Thank really a It's you, here.

stay a X-pronged So -- to I within we're two neuroscience. going by the Number to approach. going one, we're science, driven be think it's

there. and strengths coming zuranolone on on stay So definitely we that readout It's this clear very we expertise, a demonstrated for adjacencies. we But our already our I continuing are within heels. talent think -- and build We've filing mentioned neuroscience. of be very to the important point, with want with at open I pool, are example, to its the as part I XXX to our

in I lupus. think addition, are we working that In

field. So other may And specialized immunology may opportunities space. indications, that's we we the other in potential a consider consider

have that in development, believe maximize space. And continuing we had, of the on by human enhance neuroscience. we we in that's our expertise So one we've way of core you our probability fact, a success lot learnings you all the But space, risk. our and as neuroscience know, of the regulatory our validation. rebalance diversify probability would and of out in which of to genomics, in in we and success, biomarkers, building it, knowledge asymmetrical technical are Because changes strengths given move functional as clinical

concepts. ability the the So increase on probability proof to methodologies, of deliver that we which us are of us believe help these success sort and of our give will

you and integration, biosimilars add our it's digital two-pronged digital So know options. right, pillars, which health. four with also at strategy. about, to a that looking And already We're

beyond in totality. we value portfolio the in that have in modalities. expertise So the terms and narrow of this focus. really It And looks a very totality goes portfolio it's the at -- the brings

available modalities to all have us. We

targets, approaching modality with. looking reverse a to at just of you best say authority am this. of setting, the looking I I and making add we're then decisions to We're that last in of best hope we're modality. how Board So Can I we Thank of to a at way. not We're currently, you We're a at this that at the it asked gives looking modalities part? bit I those. in I exploit want would you. on the setting. how the target have do about how do lot we're that meant prioritization. I and address a glimpse forward what's in we disease management looking at a and looking and kind go

will So that, hope, go I forward.

Operator

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

Brian Abrahams

approval, Good then so And for to initiatives sense accelerated approval changes on on amyloid taking AD with approval know III that the antibodies, need just accelerated transition. your an study its you Michel beta the the of I as agreed could support wishes morning. has much, lecanemab. to you of full whether What's following don't clarify, study? latest whether accelerated leadership in stand that stance for FDA some or FDA the And own Phase But receive the of my you if could Thanks at best confirmatory can serve and approval CLARITY agency? questions. additional a with

Michel Vounatsos

Thank you for the comments. Priya?

Priya Singhal

Thank you.

have for years back, step Brian, come benefited United So accelerated is products approval pathway a several It's pathway scientific very, patients say And and regulatory through and the now. around the I'll States existed rigorous just and many that have several pathway. from highly access. very this

sure don't refinements. I'm to as dialogue, be So potential that there major to But There It enhancements, any is reading who shift. lot learnings right be But could as pathway now, believe bring obtained. are approval I'm could same the I of at a need pathway. the that critical them don't you of sort that in I happen which believe and be regulatory to more remains in products there any confidence know that way there's can accelerated our has are. really a you going I today. shaken point could patients a been

and There agreement with FDA. has And think communicated quoting number serve as is is via publicly Eisai that you that one. the a I on have on from strategy filed initiated been Accelerated CLARITY -- so us, have two, publicly just And AD, well, as -- by filing they say that this as that's Eisai been the has could that, I'll the that I'm the Number confirmatory AD So study, know. and Phase Pathway. CLARITY study. this II based Approval the commented they've

seen. think make approval? the unclear the is to strength as we comment that discussion data, science still as me forward, is this very most CLARITY and think here FDA. Now get really a to Thank the your the depending I AD I data that or ambiguous, is you. get going speculative way difference I would would that it on. approval, is we've that of evaluate thing Because complex, still what and would the the continue could to assess I to And think what the be science the is is And have question the be be emerges case. on could What for think what they to in evidence. reasonable important with to if

Operator

from take America. Meacham our Bank go question from Geoff Please ahead. next of now will We

Geoff Meacham

questions potential a there other perspective, But opportunity R&D to an I from to learned piece? in from there is I just at the lecanemab to further robust of know, assets Thanks question. on adu. mean, and expand on you when you pipeline you that a an to clearly, bring or important are Alzheimer's other lessons to behind wanted to ask you, look for jump how wanted is to guys? the the lecanemab Alzheimer's just be have is having wanted infrastructure kind strategically, I there to

Priya Singhal

Thank you.

in but we that, EMBARK of Alzheimer's all, to can only -- is And very potentially very impact think have these data critical still field. that honored Abeta removal and lecanemab we we committed invest will We agents. privileged product are the not have first X ENVISION. that also and to to disease. scientific I think remain continue Aducanumab, the

remains that So very important.

in disease We invest continue Alzheimer's early programs. to

Very I we to we inhibitor. is of have which tau an sort BIIBXXX, mentioned, then As pathology. ASO, a BIBXXX, which OGA anti-tau is approaches and have our different

very important. remains this So

well. can't which assets are others there other many, speak many pathways unnamed have as about, and which We I targets, yet but have

we remain to committed So disease. Alzheimer's

how from the our learnings We approach taking also development. we all scientific would but on approach, are definitely clinical

to to At science the area. we Yes, I've assets? we And will science are are our way. will development Would looking again, assets. the The open the continuing and and we strengthen other be as So the given drive continue to drive many to scour said, look in opportunities. any the continue the we value external at expertise time, clinical way.

and disease. to you. yes, So that's highly, say, interested we highly would committed are Alzheimer's absolutely -- to we Thank remain continue I

Operator

next We question Please will Olson go Oppenheimer. now Jay ahead. our from take from

Jay Olson

taking sheet. about Michel you. were balance to thanks his if pursue debt take is And Thanks how Thank dedication the be My to you question to transaction, much larger you on? development And for a constant question. would for the patients. to business willing

Mike McDonnell

ended for in billion think Jay, a we're balance April. question. very it's I Mike. received sheet, another cash. our in billion you the from And Thanks the that We Samsung when good place. of $X with look at quarter $X.X We

at we've and So cash on gross look you better two when And the debt. net turns turn hand. our got at of debt part of we're $X EBITDA current billion and than levels, of debt less X

but we I about we over as of XX development of in that added deployed that's bring X.X And with have. that we deals billion is that ourselves to back growth about hypothetically being years. about $X.X last to can done it's goal number business over and time. the goal X hypothetical, saying debt, to accretively billion not the We've as you a a capacity worth think deploy if turn wouldn't, $X our So

adding right some to shareholders. do is or have so cash but in for We much now that hand we prioritize to I obviously capital to with something capacity returning would business will looking continue near be And along be would incremental the say debt, debt got will development we balance. It needing term. that not do on a that we've

helpful. So hopefully, that's

Operator

Cowen We take ahead. Nadeau from go next our from Company. Please & Phil now will question

Philip Nadeau

taking Thanks for of p-value, the detail difference about talk p-value study. And X.XX need you on CDR X.XX? to meaningful follow-on you clinically a single powering in Phase this want Is a Could between success? the CDR-SB? study, on placebo is for What do my trial, the design particular, the Brian's CLARITY primary the I morning. question. bit AD Boxes? endpoint of and to the then terms in a what the sufficient III of necessary what's more Sum or in is and of is if drug Good

Priya Singhal

you. Thank

Boxes. the all, arms it. Eisai on first commented has externally and outcome powering CLARITY study, but actually the of and detect That III of has II we very Sum a several been spoken it CDR had we about was CDR Phase Boxes. statistically of for Phase In haven't significant is AD, is designed of how II to on informed the powered So Sum Phase empowered the different. difference study, has

wanted one cover. that's I aspect So to

relevant believe study Alzheimer's cognitive endpoint of boxes, kind right primary in we the primary sum feel believe, are We for and in functional we is endpoint. of give This the MCI for most that we The design And second patient and the is outcome. has this early confident that to population elements. fairly of CDR is the the that us it the disease.

hard, to speculate very we speculating, appropriately I Now that that won't designed I here. what kind and But important is be review. the study would of feel so is be the results p-value would

relevant I that of think data we honestly, had a work terms clinical highly to in And meaningfulness, There's done that, believe lot EMERGE to of with a and meaningful patients. do we we and KMEs the is clinically dialogue. of clinically have lot external XX% the ourselves. difference

of And lot sure this. a I'm done seen work the we've you've that domain. public So in around

it. comment on think don't can I Thank I that, you. Beyond

Michael Hencke

Operator, I we have for think final question. time one

Operator

Wells Fargo. Mohit We from take will go ahead. now our final Bansal Please from question

Mohit Bansal

squeezing for question a for Maybe Thanks me in. Mike. Great.

share trying comments repurchases. just just your -- So on to understand

need it the of repurchases flow in cash to this as your the back, why are company a a share diversification of good and or is maybe at be buying for that priority as assets, list? given years point couple So a more used not

Mike McDonnell

Yes.

Mohit. it. buy And on of because of business not that and believe way of we So vary development thank obviously, remainder time, we is and the quarter-to-quarter shares But do to any expect to windows, in throughout timing have can that shouldn't we activity, you remains did same the XXXX, a considerations, of the for depending you looking the we the investment. that the a continue other quarter, what But good question, stock portion utilize et during back cetera. billion $X.X at repurchasing RITUXAN, saw our we it a our TECFIDERA be of you do and situation mentioned, of and our But the X that back share at be with about investment pace as allocation, shares us throughout not and we'll operational will be between we obviously BD priorities of as rest and X, good as years balanced repurchase we ago capital see And XXXX. the continue balance will as but look forward because go. X, see to we you the is one key it a smart

Michael Hencke

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

Operator

Ladies participation. today's call. Thank you. may That and you for gentlemen, concludes Thank now conference disconnect. your you

Biogen (BIIB) 3 May 222022 Q1 Earnings call transcript