BIIB - Earnings call transcript Q3 2020

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Operator

Ladies and gentlemen, good morning. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter Earnings Call and Financial Update. [Operator Instructions] Thank you. And I would now like to turn the conference over to Mr. Investor President, Vice Mara, Relations. Joe Mr. begin Mara, conference. you may your

Joe Mara

and Biogen's third you and XXXX to morning, good Thank quarter welcome earnings call.

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

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

to over Now, turn Michel. call I the will

Michel Vounatsos

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

At time, near-term we for TECFIDERA Xth. priority, we on U.S discuss. and challenge, As the this preparing focused you Advisory highest a the our will clearly the all This are is is same know, which in meeting meeting. November aducanumab situation is Committee very scheduled for

welcome him know I to prepared to I CFO. continue, and McDonnell, Biogen contributor of and make be track know Before would new many to forward getting he record to well to a I strong accomplishment of very our like you. Mike's background Mike looks

key developments. recent some me let review Now

First, BLA that, the Priority FDA has act that our has we stated possible, are if plan accepted with to aducanumab and for they very pleased Review early.

the is on event to the As perspective to are share Committee and clinical our marketing data. application we meeting potential I participate actively Advisory former course the the are in U.S. this mentioned, Japan, submitted recent our month, we the Outside on PMDA. preparing early preparing and an authorization approval path we submission regulatory a of and Europe, for following in important with

disease. therapy proposition remained are readiness, the our launch the sites, U.S introduction the for continuing course on readiness, change Europe we first of We treatment have we prepare and potential appropriate collaboration of across as multiple to to ramp Alzheimer's Outside meaningfully stakeholders in in the Japan. up defining aducanumab's to progressed and particularly our U.S., value focused leaders, launch establishing with scientific engagement help

Beyond including small stage pioneering mid This therapies expands in continue provides potential pipeline LRRKX X with broader program, our programs are for disease advance molecule Phase proud we of company, diseases. Parkinson's aducanumab, in neuroscience a brain multiple Also, premiere us we Denali, to and approaches be collaborating BANXXXX our novel to Alzheimer's treating collaboration innovative neurodegeneration, targeting disease across targeting portfolio, tau. inhibitor multiple modalities. a which in

platform, rights using options Vehicle exclusive received amyloid Transport also for innovative programs including We to diseases neurodegenerative antibodies. two Denali's for beta

in Denali, number XX X pipeline, one most now to field, Alzheimer's disease, recent clinical and develop disease well-positioned X we collaboration X under with believe lupus now neurodegenerative recent need Phase diseases including lead dapirolizumab of aducanumab against expand and number pipeline, includes we deep review and with the for and with which deep two, novel in UCB. More initiation or both the fight pegol in the have the are the we common to broadly, with Parkinson's an treatments. assets With continued our program our Phase urgent for

the in committed to a our returns and to demands demonstrated are investments long-term. thoughtful something approach have over that patients, we the aim towards past, innovative to shareholders we As short bring maximizing therapies as for we all our both the

Let me we we strategically points. where know in are see believe as a inflection with several Biogen transitional period discuss we upcoming

the of through As we focused the our manage strong on remains erosion strategy. in TECFIDERA U.S., against execution Biogen

science tremendous the space. We medical we differentiated need core unmet to in to are leverage leader neuroscience. the in as breaking We aim capabilities this address

as to advances better leveraging therapies as imaging intractable are reduce disease genetics, many brain biomarkers, for of risk of such novel the understanding developing previously the including diseases. in help biology, as well We the underlying in

core We financial the business and MS, track opportunities. a believe in new strong of are readouts creation a important we biosimilars, and building and clinical are with SMA phase entering value record we on

for management on maximize work innovation. can our safety the as We potential the cycle biosimilars pre-symptomatic we We portfolio, to the clinically of even competition, to while driver, based to launch infants SPINRAZA greater and assessing a benefits enabled and the adults, for Despite increased well-established in the will and of potentially potential see meaningful SMA. efficacy believe to for serve another from most headroom begin its and has TYSABRI foundation safety us continue to Interferon. life broad growth grow of and profile VUMERITY SPINRAZA has care continue efficacy. MS sustained a including as higher providing profile demonstrated dose

to into new working potential the billion. with are of and global biosimilars two the U.S ophthalmology We China with expand a opportunity to $XX market commercialize approximately

meaningfully by disease potential Authorization referencing about the remain Application as the We long-term company. driver optimistic announced recently to that for Lucentis. biosimilar Alzheimer's prospect aducanumab for the this important launching the change short-term growth first of EMA therapy an Importantly, a SBXX, Samsung will Marketing course of accepted and be was Bioepis the the and

areas aducanumab, wave stroke, such our by ALS. the believe driven In lupus in we ophthalmology, to as a XXXXs, could second and pipeline growth addition enable of mid

XXXX. readouts committed and have of continue nearly end external late Importantly, expand development to pursuing we transactions. our $X just under billion stage X We the In to by mid business opportunities executed of development pipeline. business we plan years, further data expect XX X to

we will number support our new potential prioritize current while the a our for forward, organization introduction portfolio, of continue stability starting the with to Going products preparing of to of aducanumab.

serve will believe a have future pipeline. be We and In well every the of current We on patients are We deep efficiency interconnectivity focused to diligent our as well-positioned neuroscience our execution, opportunity we capturing summary, execute and portfolio, multi for on cost strategy. savings. franchise leveraging to built our we continued

focused value creation. turn on I Al long-term and shareholder we more will progress remain update in the detailed on maximizing call over We have now a recent very strong to balance sheet a R&D. our will for

Alfred Sandrock

in everyone. milestones such decline November the regulatory on working development. the partner like progression to in collaboration in the X. to regulatory through individuals meeting Biogen filings diligently for across morning, thanking their patient of dosed and mentioned, good areas, learn can committee the we preclinical Through disease. our the disease, first world. and tau whether Michel, stages suppress BANXXXX R&D reduce evaluate designed team the you, Eisai, amyloid disease. we cognitive advisory very and the progression programs. aducanumab is program, begin work key and in We're hard of This our the aducanumab, FDA procedures advancing to Alzheimer's Alzheimer's of Starting with I'd BANXXXX also results around by are which business Alzheimer's as with progress includes pathology in making of Thank significant for this preparing pipeline the AHEAD disease, the trial, hope X-XX clinical Alzheimer's as Also Michel early for

collaboration the risk neurodegenerative quarter, also increase LRRKX negative LRRKX This function certain second molecule most mutations common in gene to Parkinson's of Denali in disease. is announced we co-commercialize a disease, with small co-develop disease. of an the Denali Therapeutics, DNLXXX Parkinson's inhibitor regulator LRRKX the lysosomal exciting and and

of the kinase disease. examine inhibition in known without with We patients will and genetic Parkinson's for LRRKX potential risks therapeutic

progression two highly also Our utilizing is therapeutic preclinical Vehicle that slows oral the leveraging This brain platform barrier. a expressed the This uptake which the the Transport programs, with enhance exclusive could transferrin blood-brain molecules us of at disease. by Denali's option designed first-in-class therapy hope is that to of license to is XXX receptor, the the be provides platform. collaboration large

these of anti-beta delivery enhance an seeks to the of programs antibody One two amyloid blood-brain barrier. the across

this nervous collaborating We with a in the on enhancing to delivery system. of platform central be pleased Denali, the are pioneer molecules into large

month, trial that to Moving VUMERITY presented to associated the as at data clinically in the gastrointestinal further our AdComs MS MS-X tolerability new EVOLVE reinforced meaningful meeting the from improvement to TECFIDERA. portfolio, last compared we

of data similar currently while These TYSABRI to volumes, a has symptoms. GI missed dosing of taking of differences at real-world patients regimen. VUMERITY growing to or of TX suggested receiving reducing that symptoms that out X-week receiving of the scans efficacy compared use study, as which ongoing standard brain next in brain prospectively dosing were less an expected medication to treat concomitant interval The TYSABRI to the extended year. regimen dosing extended in contribute likelihood dosing, when to patients reported every patients dosing TX GI being body MRI analysis extended a interfered significant activities ECTRIMS, of daily PML. the with read approved data that standard with the assessed of lower experiencing is and interval work risk dosing evidence lesion atrophy efficacy associated Specifically, compared no or rates on interval in to the NOVA is new showed lesions, Also

patient data Whereas Additionally, there domains. significant domains. improvement in XX of X XX TYSABRI of of we improvements showing reported in patients treated associated with real-world X neuro quality with with OCREVUS, presented life was were in the treatment

meet were Xb to end opicinumab study disappointed Phase Moving we its pipeline, secondary of the that primary our points. learn endpoint did to AFFINITY, not MS or

we remain the to MS nervous the remyelination repairing system, patients. opicinumab. of that have discontinue has potential to still the central Nevertheless, a result, therapeutic a for decided therapeutic benefit we development committed believe provide of approach and As to

MS are including data for BIIBXXX. this set inform to We this in continuing further the to our research study from analyze area, significant

that a prior this to when advancing evaluate evaluate productive the SODX to ability in initiated ALS neuromuscular that disorders, been initiate antisense ALS report clinical I'm patient originally presymptomatic study when mutations Also XX% of Akin SPINRAZA of to could be ataxin-X of than common clinical in designed most that we that plans We TDP-XX to symptom the modifier populations, FDA, of carriers have X SMA, to study Phase a reduction next to in is benefit progression Turning a initiated study as first the disease in tofersen of of happy therapeutic more to toxicity, following this targeting engagement to was BIIBXXX in tofersen the oligonucleotide the of to ALS. plan with ataxin-X. other are Ataxin-X than to pathology we SODX. dose slow or onset. identified population across of onset linked the suggesting to year. our due study ALS study ALS delay in NURTURE for

of made use discontinue would dorsal BIIBXXX due we've also placed Thus update AAV currently toxicity. I gene generation a SMA focus to of FDA pursuit the therapy following the a commonly occur and may hold available mediated will had believe to clinical the will DRG Additionally, technology therapy on therapy. ganglion in gene gene BIIBXXX that The BIIBXXX. on instead like preclinical on we our which observed the and an SMA provide asset decision pathology next address SMA previously to root toxicity, studies

summary, UCB, to and happy that external first erythematosus pegol are to care seeks X approach with enhance This with dosed on for continue lupus dapirolizumab build needs being disease, we standard program -- Lastly, we both pipeline advance a of announce with despite drive development believe is with our Scribe mix in in that neuroscience by growth CRISPR Phase and for to In Denali internal leveraging to agreement deep potentially patient where address edge systemic ALS. to have organic and pursuing recent in patients' collaboration our Therapeutics external collaboration. therapies. of and patients we the evidenced this of by sustained allows call programs develop to us We technology source now to we our cutting help provides therapies are value long-term also gene I pass the company. innovation will maximize growth and Mike. of the R&D of collaboration to a active the

Michael McDonnell

and MS a billion, prior during impact. to experience million, of the driven the prior OCREVUS quarter continued financial the Total U.S and TECFIDERA Biogen decline we join the of to with as $X.X U.S., strong entrants long-term. prior year. unfavorable you. solid revenue remain currency look full versus significant I'm royalties of inclusive Good was while you, is recent and multiple to performance in versus excited grow by decline cash Total review TECFIDERA many mostly $X.X in getting financial X% was year outside was also year continue generic the Thank the This execute to growth. impact and of MS position QX for morning, TECFIDERA a X% revenue business quarter revenue very an third decrease I to over was X% guidance. of began impacts generics increase $XXX Biogen now the of everyone. continued the of financial billion, QX continue the the know to TECFIDERA including forward generic provide our the a of in of to revenue, versus entrants representing despite will had year. entry X% to another well. We of an a capacity Al. and the COVID-XX with our update quarter the patient

an VUMERITY TYSABRI strong quarter, had the new a of We number differentiated to home versus increasingly is improvement million, QX believe well-positioned saw growing X% We MS. extended several TYSABRI with an versus GI treatment tolerability believe for administration, are and growth global the an be We quarter important year. infusion given can we including its pleased working year. subcutaneous see the Al X% an And for we option $XXX on starts. interval patient of During were increased revenue option global mentioned. prior in play TYSABRI an important product to including the for important dosing. prior as in profile, initiatives, VUMERITY role of trends, continued of

U.S., revenue as a SPINRAZA on XX% revenue Moving to stable versus additional competition. quarter versus now prior was SPINRAZA by the as $XXX decrease year was of see versus XX% the the decreased the impact third Outside million, the starts SPINRAZA U.S., year In maintenance to and SMA. quarter. an we prior versus continue new the COVID-XX well quarter. as XX% versus Global prior both doses, grew prior and the stable year revenue of and prior

had the efficacy global patients new growth markets. profile impact and strong for we on a COVID-XX an Although and emerging significant competition of safety untreated across SPINRAZA, potential given and and see established number have a very many

of despite patients biosimilar XX% believe one of first QX Europe. largest million and a impacted XXXX. our COVID-XX. an product biosimilars negatively increase continued there Revenue result patients new slowdown geographies. this was etanercept COVID due a returning erosion year to business. biosimilars increased as $XXX with immunology decrease continued royalties other versus from X% RITUXAN. and opportunity in increased to third within million, in a other well to U.S expect anti-CDXX versus XX, prior million. grow OCREVUS continue to revenue approximately QX $XXX offset Europe, QX quarter Total revenue biosimilars, trend -- our estimate the as in growth to to XXX,XXX Moving by a And number the be our impact in quarter, we approximately now as the $XXX the using QX decreased Total reduce to for prescribed was in potentially of versus and biosimilars continue RITUXAN from and XXXX XX% Europe. we to revenue, we are treatments clinic in became revenue across BENEPALI to by the We the have capacity

million core significant non-GAAP reflect expense million million reflect material to or of was of and SG&A GAAP also million of payment revenue. order collaboration revenue. as GAAP or payments better operating expense. revenue. XX% R&D quarter associated XX% are QX now non-GAAP non-GAAP Beginning Sangamo the Denali to collaboration change from expense Year-to-date, excluded $XXX also R&D both expense, the non-GAAP in in Turning with collaboration which to results our $XXX $XXX of $XXX arrangements QX, this performance. in XXXX expense second been QX billion with excluded now Non-GAAP of upfront upfront to with related R&D SG&A were licensing of from and has the our XX% related R&D million expenses. was excludes $X.X $XXX

Within the VUMERITY although aducanumab, launch TECFIDERA reallocating are U.S., fully as support support continue resources to to we as well of broader MS our some will the portfolio. we

our which are upward for addition, preparations up create In SG&A. pressure ramping aducanumab, commercial some we will on

third approximately However, from reform to our effective as we manage ensure quarter as adjustments TECFIDERA. This non-cash current remain XXXX. approximately tax this driven diligently continue tax by related In is will we increase prior tax year organization. year Swiss XX%, the always, primarily increase the XX% QX across well expenses was deferred operating of from rate our in unfavorability, GAAP favorability to efficient due as an of to primarily to year,

our an in approximately XX% of tax For of third increase was XXXX. XX%, approximately the effective quarter third XXXX, quarter the from non-GAAP rate

net a quarter repurchased $X.XX, a $X.X non-GAAP decrease in was GAAP of billion. income of EPS GAAP We for $X.X earnings share diluted marketable billion X.X authorized in billion. the diluted in billion the expenditures million $X.X in of In We authorized from Board and $X debt. net our flow was billion operations. of quarter has and cash were QX, Capital XXXX approximately XX, with cash a value completed QX versus total and year $X.X free repurchase decrease $X.X prior net and securities cash a as share Third in of ended versus $X.X September Directors XX% quarter December program. XXXX approximately $XX billion. we QX billion new The was flows shares X% year. in prior was approximately non-GAAP repurchase and per the was in $X.XX, third million program the million $XXX income was approximately of generated and share

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

update year XXXX. me for our to provide guidance an Let full now

last was no guidance and entry in updated TECFIDERA. for Our assumed generic July

entrants at in During X generics market third quarter, prices and approximately of now more the XX to began we least of impact the the discounted experience TECFIDERA with generic approved XX%. than and

Our predict. which the of of guidance assumes pace in of XXXX, significant fourth quarter to the erosion is difficult TECFIDERA

we now billion. expect full $XX.X to result, a between billion revenue As to be year $XX.X approximately

associated that We note, $XX.XX, payments $XX.XX be to $X.XX diluted diluted respectively. to XXXX, quarters and upfront note associated second with impacts the the $XX.XX. to transaction elements year important collaborations assumes between equates September It's large share. to per and non-GAAP EPS as and to or and new roughly business foreign comments. that Sangamo as remainder Denali payment for are predict. the both GAAP the this excludes to and during does that exchange now in of the Of Sangamo Michel for expect also the from remain back of upfront XXXX include call between The be potential hard this QX range rates guidance $XX.XX EPS This third year. XXXX full financial with guidance not have development turn the effect acquisitions transactions, over his I'll XX, of closing

Michel Vounatsos

the Thank while efficiently, our MS, biosimilars, we in shareholders Biogen maximizing you, execution to continuing effectively, appropriately. SMA a core to requires that building and multi-franchise innovative capital and now on our and over bring strategy remained reiterate in business our long-term. commitment to participation allocate portfolio. to continue and strong focused I to This Mike. returns want has across advance of our

aim caring long-term past, we for returns over billion creates optimal the and in By Alzheimer's $XXX for per cost unmet a are need patients, will burden for U.S aducanumab have $XXX,XXX of to year be launch. people of as cost an from and age preparing important investments Alzheimer's are approval a driver growth deprives Alzheimer's approximately the and well will make. large, The short-term approximately in potential home cost The live year. in per a at an at for society for demonstrated As $X.X of structure, per mounting. can strive we and of XX% Alzheimer's disease and Committee an a the milestone Advisory Again, their we million. Alzheimer's cost to approximately as tremendous an of the for the for we medical patients be superior the the company. patient actively always have capital many and nursing independence. XX, with and aducanumab patient would society represent families unprecedented of

we our This accelerating These doing interrelated. we value. purpose in advancing includes science focused the employees, Finally, on to environment, sustainable patients, which an the thing of aim are the contribute pioneer for broader betterment long-term to efforts as all issues and while and right as of all the for organization, believe we diversity humanity. shareholder community, are inclusion, our our

of be For example, to our Healthy am environmental to emissions issues change a I launched by $XXX fuel action taking Lives positive XX-year, equity. and human science Healthy promote health. the and million eliminate health impact how fossil This recently central fuel are to end, our goal XXXX by that proud incredibly initiative. fossil human To Climate, around advancing catalyst a for to health climate and includes

are dedicated would questions. to around world, our life, who to thank challenging I With a that, call positive the impact employees times. during for patients ensuring on will therapies access Finally, open these we making the to including our

Operator

comes with Sachs. Thank you. Your Flynn [Operator first Instructions] Terence from question Goldman

Terence Flynn

questions. Thanks morning. taking good for Hi, my

should to frame analyses data benefit prepared And or try call notable we AdCom, then similarities the new on you you. can here the the drug for expect here? congratulations of to in on that differences you've Thank hear the points that European filing. for European the notable out any As or risk as FDA Anything with you discussions terms side? the your about versus

Alfred Sandrock

exceptionally hard that for We've Al. perspective we're excited hard our lots for that prepare of about we the AdCom, working more are is the doing been collaboration Hi. and team and with to analysis. than year day. a This sharing is We exceptionally on We've in FDA. working -- very done

Terence Flynn

difference -- EU the the in On EU? difference

Alfred Sandrock

and after interactions soon. start filing are our hear filed The the and just and in we'll just Japan, we formal be we to engagement And EU, formal back had some meetings expect process. we

Operator

next Goodman with We Leerink. from will Marc SVB our take question

Marc Goodman

good about is expenses. really morning. Hi, Question

a TECFIDERA how or not of to $X type lose billion and was I VUMERITY is that? cutting you're I to cost you some about the just rate those of any can I big You're there, at just about secondarily, implications understand mean, significant there's because offset sales come tax between and then talk announcing still just of disconnect sales sales, Thank curious going but with help two. sales you. restructuring that plan, clearly those two TECFIDERA away? And

Michel Vounatsos

the So, question. thanks for good

looking and We at opportunity did be and how we material TEC approximately from savings are when additional be $XXX try save measures and simpler of of infrastructure always which order mostly have to certainly to array in the to a the obviously an to million We resources. an and our impact. face simplify U.S, even more is in operation we in efficient launch leaner back in order place potential a organization, extract the office

to we a we'll plus need good MS signs leadership environment our absolutely to some with position. it. still but in is and demonstrating for that highly in You billion where immaterial order obviously have the now, signing is competitive back a to $X we come business need defend to resource understand VUMERITY

really save to to of need we are We and can. business. what obviously and base But to need we we the to the of utilization resource launch try COVID aducanumab. at efficiency. there's and to aducanumab, VUMERITY, So on resource we to learning optimistic for the use we We again, the because launch continue same need stay the from continue prepare time, and to also gain

Michael McDonnell

Yes.

that, Mike add quickly to Thanks much speaking. just question, Marc. I'll for very So the

running like just a Michel XX% saying, pretty think at to revenue to color, efficiently. add it I runs was about of we little of feel bit what SG&A,

we and and VUMERITY. are the to reacting we just guiding but quarter, we'll obviously we in we're this support only remarks. about to savings the talk get the some around which see 'XX around to said, the XXXX, resources more for MS XXXX. continue cost need And a point time. fourth Michel we out wouldn't this obviously reallocating you for On comment I not any your I were when prepared cost that of guided do to tax impacts the As until have, But that in aducanumab costs support launch rate, you at we think to question would franchise,

Given was for impact TECFIDERA, had profile on to evaluation the the booked deferred profile the quarter. effective the to modest and adjustment a be flow profitability rate cash was there allowance, required which the that in tax change a for tax relating

hopefully So helpful. that's

Michel Vounatsos

I if what said, market still and ex-U.S. remove to above are growing. $X Mike U.S there TECFIDERA So add where launching completely the may some If we a is And TECFIDERA. billion countries we are it's

and resource overall MS So the $X continuing plus to ex-U.S. we see billion franchise TECFIDERA also

Operator

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

Matthew Harrison

subgroup just benefit in would you to the Thanks. better patient comment If Good think FDA a think the population? about morning. risk potential as comment guess, you question. could you helpful. about on overall can and approving is Committee Thanks that where the aducanumab approval, I about in taking Mike, may think be Great. the on Advisory And then, path what the for trends that think they of patients to you think guys certain compared do you inventory the risk is quarter? that, the

Alfred Sandrock

look, is the Matthew. data. Hi, We has FDA This Al. -- all the

including believe a aducanumab the at We all has it's efficacy. sharing believe we substantial look wouldn't Committee, forward continue this to evidence potential that hands FDA Advisory at that filed. And the FDA's And of data If to subgroups. the point. didn't have we we in

Joe Mara

is Yes, this Joe.

not that we significant terms in the of question just out. and a something would impact called quarter I on wasn't inventory, your it say, In

Operator

take ISI. Umer will from Evercore next Raffat We our question with

Umer Raffat

remind just you guys FDA? EU but I weren't of to you're with versus than the focus to And the I'm is showing. that in least they're something And that, FDA were EU the efficacy speak it's looked what assumption to not on without is carriers? to were Hi expect with guys. can day the presented, raising, quite Al, efficacy groups, be know for if overall is was say at the Thanks the the Is at I you only today, -- several on there there consistent the data And you consistent two us patients very I call important non but analysis, can the delta that for call FDA. is you I'd consistent different well if when those as filing. expecting the taking you decided which this file overall the Michel. curious know ARIA, aspects super my if was conclusion? APOEX carriers question. don't I whether you excited if of Michel, the with virtual as nature hearing know probably think we on data

Michel Vounatsos

take first part of let your question, So Umer. me the

excited So the cascade, about the agencies all actually influence FDA, regulators we U.S to regulators. equally U.S to our data. we all meet FDA world. by with all certainly share who wanted on said and refocus a around team us as to Having wanted that, the We the had the the were will interactions other because are approved

So I and will all cetera. Australia, not speak Switzerland, about Canada, China et markets, the

will and focus we are U.S the So hopefully. are naturally, excited X, is optimistic and certainly then November unfold we others the on the FDA, the

Alfred Sandrock

there's But subgroup advisors as will look, carriers non prepared. at what to versus to we they we're I the the FDA Umer. Committee. Hi, -- if ask go On our haven't your carriers, Advisory there, don't We're speculate the question yet. about want shown data --

perspective the comes to come we're some up on for and I data, our will point all know share But at the Committee. it up. at Advisory We eager may whatever

Operator

We Evan with Credit Seigerman will question Suisse. next from take our

Evan Seigerman

so the much question. Thank Hi for there. taking you

you So phone. on one from nice meet the Michael, to

repurchase maybe So you. do aducanumab, TECFIDERA, now program erosion your how with earnings seeing? from decline you revenues? grow addressing and capital to Aside you opt authorize revenue allocating plan the on an additional in say, to did we're why that this share elsewhere help of versus, Thank

Michael McDonnell

Sure. Evan, for very capital. very meet nice the active and you, of has now Biogen to been period thanks time a much in allocating question. for Look,

capital as X remarks, in sheet. billion shareholders in modest transactions of and As $X.X form Michel net mentioned billion. on $X.X debt, of company got think in company the we've active of the end notwithstanding repurchase I obviously to both very we the flow of those has approaching and are TECFIDERA, debt, with We've significant continue. And has and the of we're share on to still for A been the prepared September. cash got buybacks. the billion, the to significant with logic a of situation and $X And years, last hand BD the front XX that to very repurchases the just BD going amount of activities the expect we And as continue aligns share balance utilize cash share that. intend completely before. going pristine both to just be returned Obviously,

Evan Seigerman

you. Thank great. Okay,

Michel Vounatsos

we momentum prepared Evan, -- that. on to both. on the both. remain, do hard organization very business and have Return continue the to and BD active So can and shareholder shareholders, we also adds do very to Working the capital to the for

Evan Seigerman

you. Thank Great.

Operator

with next our take question will Phil We Cowen from Nadeau and Company.

Phil Nadeau

to the to benefit positive going documents proofing of you And for the deal argument key then us question risk. your on X released a side, a highlight, Good weeks my give maybe one What for asked how see the about if dodged with received parts is of preview been yet? of AdCom, questions your kind what I'm you are a Al, argument of before elements has of then Thanks. you morning. Thanks you've area? expect I'm taking times to few just a the brief what kind the aducanumab question. Biogen that be. has where publicly, the we of but you. just curious It data will curious them that. follow-up is the risk and

Alfred Sandrock

have our pre-specified EMERGE, positive primary look in and fact endpoints. on we on robustly So, secondary the all positive study the argument that a rests

titration. trial, the We ago. in is few is have we in with from a believe detract the that how have it believe Nature we study. main negative manageable And was with doesn't learned we Xb our of a risks, with ARIA. ENGAGE MRI the We terms and published it's deal understand study, we've years risk in monitoring, Phase and that then it was the which study And positive belief ENGAGE to supportive why a

the that, didn't If we believe risk of benefit approval. And filed. we worthy so wouldn't we is think have

days not FDA in will book. the it to as so prior -- on to the briefing -- we're the going briefing It'll Advisory And book, in actual X be stated available register, the and meeting. publicly made comment of that's terms Committee

Operator

with one Jefferies. question We Michael Yee from our will take next

Michael Yee

question. for the Thanks Hi.

up, that on following just plan about does can Is maybe comment that act Just to mean? the how may language you and just FDA What you early? the way earlier emphasizing keep that.

Because if add that it that any case be that. early, the you you rightsize color way Just was actually this, some you that So if be -- much. actually maybe happened? just you would a it's optimistic if it just you think ready And is on what lot not literally which which that launch be can to way, Thank so -- need just day there. for color adjusted? if some preparing to but would spent goes maybe I going? And expenses

Alfred Sandrock

Michael. the take first I'll part,

has acting terms since of the early, June. had In data the FDA last

right data. Type be Advisory see we they act relative early. early sent the until them March. that pretty that they early could after date first And have the we That meeting, C one -- the primary first to scheduled Our they all Committee our said of timeframe the why PDUFA has reason could

ahead. go Okay,

Michel Vounatsos

Concerning the yes. absolutely launch is readiness, the answer short

scientific continued leaders. have have medical -- the engagement increased We with we

We payers. have engaged with

the We are and potential proposition working the on price. value

progress. a to across on They're working There despite the readiness. We are making to site and team engage is COVID. willing functional meet

strong. anticipate which Patient already from we and very the many patients. increased certainly for baseline because call advice engagement services the enhanced have been many, was We has patient digital capability requests

one there's from very disease population, a with very and the the a pleased important the with broader the we we the but so a most only somehow, specialist, have launch the are first And the all the the is burden approach going then centers, progress. We building high is specializing even treatment high the to again, rigorous of focusing interest if obviously that to meet, which potential Medicare. parties by on engaging the infrastructure challenge,

We will be ready.

Joe Mara

and just which last the address … part, expenses is You

Michael McDonnell

scenario I hopefully, planning mean, is that of I approval. and think Yes. we the look, we're unlikely our launch toward optimism a aducanumab, event is don't clear successful hopefully have and

Of base. to have we look cost would obligation at our course, an

Michael Yee

helpful. Very guys. you Thank

Operator

our JPMorgan. Cory from take with will Kasimov next We question

Cory Kasimov

Good question. thoughts With products upfront to is asking there around for a mentioned SPINRAZA on any mean, the wanted you of one? way to I the taking how I if putting the horse. can a down you about what morning, just follow-up price XX% And before acknowledge well best effects bit cart be quarter, just since talk to potentially Great. Thanks both potential to just Is summarize aducanumab to your something, delineate will and everyone Michel, about on sales this the two, this guys. for approved, do latest pricing. talk housekeeping continued giant But little to that I you roughly a to and seems that COVID. to accessibility? as kind Michael. to competition alluded as speaking, each of just

Michel Vounatsos

are we making approved, and price the be it pharmacoeconomists, broadly with also still should potential progress for So premature. ICER other are we on aducanumab, engaging it's But advisors.

so society the earlier, to high. I into cost note is As the alluded

the will by will very the patients, assessing on the that starting We meaningfulness and the the are to customers, clearly be value the provide set aducanumab different of caregivers, payers certainly what working year -- creation product, the related but potentially patent all the not one, that when even the this to and life beyond expires. the aspects aducanumab the over patent only bring, will of value entire clinical

early. too it's So

this that we question. are We and to will taking come back

and would We say, from have others. a advice serious I lot and of, focus dedication

Michael McDonnell

data to just some second of So, hopefully that helpful in the question are and on kind year-over-year speaking your of terms. try give you Cory, points I'll part

few charts product One So patients put XX% are up actually factor see is this XX% year-over-year. up globally things. we And into some dynamics. dosing that dynamics down you'll SPINRAZA that of And the was that in year-over-year. the a are

matures. maintenance have as doses doses versus the product We loading fewer

coming can't see Secondly, COVID there reason going is. delays, the there know some we when patients we've and precisely had the that doses is adds from get and to where to tease is, from are to part and some here, out, treatments. getting but mix number what of tell COVID lower. competition in patient impacts. not Evrysdi. hard there It's There's is new are mix that that We so the kind prices those of ZolGensma we the some dosing lastly into related is certainly and through to And you fewer of countries loading are growth country patient speak,

tease is what that metrics hopefully those that the helpful. know are We gave it kind those of is. all out. the say to precisely not COVID mix and piece in are So the completely you It's mix can in something I somewhat we

Cory Kasimov

Yes, definitely. Thank you.

Michael McDonnell

you. Thank

Operator

next Bernstein. our Ronny Gal take will We question with from

Ronny Gal

cost basically to just cost Congratulations. Thank you a phone. the know message do we structure how will before but this. clarification. meeting you might we a look our to call. One, the again, the take on on nice outcome decide aducanumab look, have of And for at that, The we the wait structure, initially until we

guys just give starts we we gone And about internationally, can us market the just a the can side, have of so SMA second, is, you structure the kind in message cost up. on this would the new Just share forward of U.S to in a this clarifying think of and for has model split staying XXXX. as your that feel how

Michael McDonnell

Sure.

Mike speaking. So, Ronny, it's

gearing on add on, very of we're for focused And getting the up your does launch SG&A. pressure costs, interpretation to some we've aducanumab we're is So as that that something obviously right. said, on a that

reallocated the well have some prepared to resources, as remarks the in VUMERITY. We as from TECFIDERA said, I aducanumab of support as

We to support platform. are the going to continue MS

As remember. Michel said, $X TECFIDERA, over to franchise the which have U.S we a of in important is outside billion

our of more kind year about get we'll terms of XXXX quarter that so the to at metrics financial time. And fourth say in we that And provide all and to have -- state of we've next for guided play into presumably as the of today. guidance that's

Alfred Sandrock

to your part in detail level of second whatnot. and starts the shares in we've in kind that gotten of Ronny, new Yes, I don't of question, terms think of

Michel Vounatsos

clearly bit -- and potential and are [ph] to time that that sure increases oral a the But efficacy XXX showing dynamic, get milligram is data tox SPINRAZA X and is the a only with dosing what it's of times year convenience. and in and of a dose. in if a some physicians you terms a least impact the Recently ceiling mostly we But while recent But of is launch. medication, SUNFISH being the launch, at I be perceived the the that. of that market patients at limitation patients attracted add you combined because certainly easy, can versus the on weight not more of the times may nevertheless, a want, COVID it generating with the challenging from but the of of target take X understandable environment start kit see year some U.S by color and this because with potentially switch aware

is end data So prevail, once that we that SPINRAZA remain and the this world efficacy have adults why profile mostly enthusiasm we presymptomatic That's evidence the real the based at a believe bit infants will safety the on all of should of the day, we reasonably wave to from prevail. symptomatic optimistic behind us. and about

Ronny Gal

you. Thank Okay.

Operator

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

Geoff Meacham

do on or some thanks favorable the more be announced to of quick BD, ones. the think today the the billion guys, follow-up could the a buyback a doesn't aggressive panel chance If for Michel, for changes approve, preclude those larger, more SPINRAZA. I doing then $X question. a you And Hey of just had isn't transformational does potential strategy? what it's of deal? FDA quick the on couple just

Just, how an the market? much the much. of dynamic was would in that in directionally very Thank bigger for switch play be can OUS you U.S the you indicator and speak quarter this that

Michel Vounatsos

we if underlying strong seem therapy reminding the every launch foundational on position. SPINRAZA to I’m about over very optimistic what are switched on a Concerning are of you SMA. ADU just I like approximately we fails, that very in the strategy ADU think will remain Well, that remain the for assessing again, about this first saw start SPINRAZA, question -- But to profitable. confident But time still -- patients, launch new and treatment the We start of is. the being assumption. potential the to we mistaken XXX by if So, is we're we not be the to nevertheless, day. do would on

sheet, balance CNS, large have have in and creation. deep We enable and have portfolio this a we a a we and long-term growth value will pipeline, strong

case are by the will failing. the not of ADU affected event, they certainly in necessarily be So binary defined prospects but

have and pipeline, in a have ALS we in We in stroke, biosimilars. in opportunity optha, lupus,

the deal bigger Denali. have We with

entire SMA, disease We X. assets, portfolio I and rest SPINRAZA Phase in And of the portfolio have here leadership believe And the in management the have we we the or still said, overall I therapy. with have in filed, neurodegenerative position opportunities. AD, that XX life will clinical remain X as foundational cycle the

time, all So the there discipline will as be by the discussed cost Mike.

Michael McDonnell

Yes, as point you mentioned, it whether we answer is, said I the is that precludes before and you BD, the I think doesn’t. just other share authorization would add asked the repurchase

no both. to the that very There's on just We would remind flexible. And will do it. authorization is I timestamp continue

we So continue great position we sheet and we’re about. a have which that’s balance a be pleased in and will active, do both to

Geoff Meacham

Okay. Thank you.

Michael McDonnell

you. Thank

Operator

will We Canaccord. from with Sumant our question Kulkarni next take

Sumant Kulkarni

know formal caused we expect do you program the potential Good but evaluation for a day place? be launch morning. taking ready litigation is in the And you put on are strategy the you Thanks aducanumab REMS around by said If to program? and approved, my about infrastructure question. to burden risk one, what

Alfred Sandrock

point. This hard it’s is Al. this With say to respect to the REMS program, at

up we believe to a would is learned FDA. I community is process. review to over how not REMS the that risk manageable that the ARIA this the the the in years. and still risk or manage Whether of are has We say that requires

Sumant Kulkarni

you. Thank

Joe Mara

if the don’t repeat question Maybe mind? -- other you for of that the us, part can you

Sumant Kulkarni

infrastructure a Just by that to to in the case ready about in place? burden potential go one caused program, you around the have REMS need is

Alfred Sandrock

done Well, how We before. to that may they whatever REMS we’ve programs, do know be.

of including yes, one that, for ready aspects typically which the be would we programs. is so most of And the piece, REMS important education

Sumant Kulkarni

Got Thank you. it.

Operator

from our We question will Oppenheimer. Jay with Olson take next

Jay Olson

ask about taking for to gears the I’d you like Thank and disease. Hi. Parkinson’s switch questions.

alpha-synuclein share in an your then and with of gene there could neurodegeneration, Parkinson’s had recently you been development competitors. future of disease vision LRRKX have leader treatment where from then Denali And program efficacy signals for Prothena you you a in with the therapies Roche. and your also As there's antibody several and

do So, you. fit is you most which the approaches Biogen of competitive Thank where landscape? these think and promising into does

Alfred Sandrock

Yes, thank you much. very

the excited Parkinson’s about we we’re So disease. potential -- in very

you Roche some have more so on It's measures the of months. As in support alpha-synuclein in alpha-synuclein, Society presented there meeting imaging And in as additional we Parts out, and ago. for it's and about I was of a specific measures that antibody. efficacy from digital Movement Prothena, or score pointed some aggregated antibody different, looked Disorder that the at the a outcome X UPDRS like forms with and believe sense own the we the month readout expect coming X our

alpha-synuclein. against directed program oligonucleotide antisense have also We

pointed the inhibitor. out LRRKX You

the there, XXX of oral just Denali program, have ample even other in have program We not there LRRKX molecule inhibitor. also work And could small mutations. the PD, patients but an don’t that patients hypofunction that mutations, evidence with lead LRRKX LRRKX in cases lysosomal is of

pointed who are work disease. that And a range gene, so heterozygous have out patients as Gaucher’s Those an the arguably storage are of have Parkinson’s GBA patients. lysosomal then who GBA, increased could for it in potential is as of you on disease. disease or risk broad lysosomal homozygous other there And Parkinson’s

Vehicle as which that against Parkinson’s program. this I’d Transport with directed opportunities to includes the have well. also that deal we gene said, only disease two did have license a disease. we in Alzheimer’s but not I out the point programs so year preclinical programs earlier with therapy we And as Sangamo, programs And ability also

alpha-synuclein. programs lead there's gene therapy our a of One on program

So, I a broad range. there's think

and and our we multiple there's by antisense lot I well very as oligonucleotides have genetics disposal. of at validated humans think a data in clinical pathologic therapies, molecules, human gene as validated modalities, small targets, good, by

Joe Mara

Thank questions. for time We probably have one you. all about the more. We appreciate

Operator

we And Abrahams Brian will Markets. with RBC from next take Capital question our

Brian Abrahams

so taking for question. my Hey, much guys. Thanks

franchise, in then just the early and the particular regulators see they’re additional early? X/X quickly meetings as ex-U.S. to touched on online there on exclusivity outside you of come relatively potential for really would XXX, your MS several probably Japan had agents Phase rollout you And curious, on the the held such act all after the and U.S. whether some you and next-generation like that from So, on you’ve specifically, of XXX, those I’m you study conducted additional regulatory Japan, got aducanumab. feedback in losses. XXX but

long So mid-stage for augmenting fruition predilection you're these how down come about whether until the MS there, just flexing have thinking commercial lifecycle a wondering you term the thinking to about have are you leverage to infrastructure place? in or Thanks. spend portfolio you the

Alfred Sandrock

mean, I States, think ex-U.S. equally of in aren’t optimistic filed in to just even of advanced the Brian, EMA, terms said, are as So, procedure. haven’t filed I United Japan. we filings Michel as the respect about just yet We in with we outside filings, we

procedures. optimistic. the And so, we And regulatory eager equally start Michel as are to are we said,

On … part second the

Michel Vounatsos

label, early and we pipe with pipe, TYSABRI, and the in On and management or advancements opportunities EIV, with new lifecycle Plegridy, BTK clinical a that the of lifecycle MS management co-develop in terms with the of program subcu, develop the been to our our some Avonex, we’ve MS, never of all products opportunities IM. have we portfolio and reach with have

And class very physicians. crowded. of plenty have segment well you to becomes that very the efficacy potential TYSABRI by documented becomes -- very as becomes opportunities So patients it’s -- the and do despite aducanumab high the well, create to well continues because of market we events. launch saw the appreciated of and product a the

the And the of an commitment would confident [ph] So challenging is this facing remuneration the the franchise I over we rest say, the are long-term. beyond very of in U.S. in for with the beyond entire the are portfolio, RMS situation case. the TEC beyond company specific we There

MS to like one. So, support continues Biogen day

attention. Exciting news looking Have and early you AdCom thank you taking good the company the all the to after all. all Biogen, are more So your forward forward this next day. a at for event. November looking time Thank step for and for we from

Operator

your participation. Ladies this you today's thank gentlemen, for we call, concludes and and

You now disconnect. may

Biogen (BIIB) 21 Oct 202020 Q3 Earnings call transcript