BIIB - Earnings call transcript Q3 2018

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Operator

Good morning. My name is Dan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter 2018 Financial Results and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. you. Thank Instructions] [Operator like the now Mr. over to would conference turn to I Calistri, Relations. President, Matt Investor Vice

begin conference. may You your

Matt Calistri

Thank, Dan. Thank quarter XXXX you. And welcome conference to call. earnings Biogen's third

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

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

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

Officer, We will Medical call Al Dr. also Chief be joined our Sandrock. for the the Q&A portion by of

releases available. Investor releases this now And the earnings when conclude, via to of to to We become I Investors we www.biogen.com. Biogen's everyone, post and call earnings related of Newswire releases instead on issue and website, I and Before would do Twitter any publishing like Events section related also earnings they calls Events that services. statement Investor on remind

@biogen. Our Twitter is handle

I’ll turn to the Now, Michel. over call

Michel Vounatsos

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

quarter XX% $X.XX earnings some third EPS with and share to grew grew XX% to grew ago, a period year begin the to Biogen's per me billion, quarter Compared highlights. GAAP same to revenues $X.XX. financial third XX% let First, $X.X non-GAAP

growth, as strategy our are year-over-year We with to our this long-term pleased continue solidify in we and bottom leadership neuroscience. position execute line on double-digit topline to

the we quarter. third me delivered accomplishments in let Now review the

MS our of U.S., The prior we patients number for remained products the and globally saw billion. prior U.S. OCREVUS year we across on geographies. core continued and to on TYSABRI add multiple royalties year-over-year First, business relatively the revenues stable remained $X.X trends our versus the basis. of delivered year. stable MS including Outside patients increasing both TECFIDERA also a In versus

now $XXX of in growth million, Second, U.S. patients driven quarter-over-quarter and by the program approximately continued trials. The by even from revenue and we commercial revenues quarter close SPINRAZA grew clinical to growth including on revenue to making year-over-year global the the X,XXX SPINRAZA, and and have on XX% U.S., number patients U.S. expanded increased last outside access the In greater SPINRAZA we across more then progress SPINRAZA America. SPINRAZA multiple lead not growth XX% Europe, significant from contribution the U.S., with to adult geographies XX% revenue also with increasing third adults, pace for Latin on from new compared and the last were meaningful the but starts In patients populated reimbursement Asia-Pac to Outside of revenue just the adults. of by of quarter number quarter. more then

received more two more have filings. have five regulatory We approval made regulatory we and countries in

in the bullbar assistance without data profile countries, to genetically kind us was neuroscience. All diagnosed SMA with SPINRAZA, SPINRAZA to including the and new sit announce We that SPINRAZA. Canada function. able ventilation innovation patients were milestones with without We most the patient very generating able formal that of presymptomatic proud also now markets. was normal long-term tackle secured treated XX the achieving inspires efficacy with NURTURE some the many development. broad formal consistent areas alive to with we reimbursement infants of XX normal were and challenging were reimbursement data progress and were in populations have or and study is four additional XX% compelling We from of XX patients difficult either believe the This walk or within and across of XX% disease support. are underscore independently of a the to

remyelination areas develop probability prioritize to Third, we areas of our in our depth X for highest leadership Barcelona. success, expand in data position, our the we with look Within potential Eisai leading continue meeting at as Opicinumab, and while disease working and to CTAD trial we this MS quarter a neuroimmunology with enrolment are long-term Alzheimer's investments we of Phase industry towards core to Along neuroscience of of our the expertise. presenting building week therapy. are we completed portfolio pipeline this

ALS We the and about optimistic trial are X BIIBXXX we BIIBXXX, targeting be CXORFXX Phase building to in SOD-X diseases initiation neuromuscular of of cause continue for potential the genetic for ASO the with a of most common depth ALS. for an targeting

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growth Phase trial in area continue IV neurology And pulmonary our a the acute pipeline. in on infarction. of entire initiated we dosed trial across patient development X hemispheric will Xb the X more BIIBXXX, our beyond in Phase Mike, first-in-class also our fibrosis. We advance for large a details to neuroscience our BGXX Parkinson's of disease. first BIIBXXX pipeline Phase Within of provide we emerging for idiopathic glibenclamide

patients. year-over-year. in for With XXX,XXX biosimilars physicians innovative We treated per of Europe. Last can there We biosimilars represents now in $X our needs significant an adalimumab biosimilar Europe. are Our main that the offer referencing to more with patients biosimilar IMRALDI IMRALDI, week business to create year European the our we launched options from grew XX% HUMIRA. of $XXX meet several European headroom market than believe which with revenues approximately with in markets, therapies. three now anti-TNFs, are IMRALDI markets available the savings is able of now in we providing believe more to originator biosimilars growth billion million,

we exercised our As expect the approximately by venture close own and Samsung the XX.X% of end to Biopis joint the of this a to transaction we reminder, year. option

and business to beginning shares. Importantly, very generation optionality with year, allocate provide us the we cash and remains the continue XX.X strong five of Since repurchased significant our flexibility and have to completed million development deals capital.

operations. we quarter, cash billion third flow the During from $X.X generated in

for development to board continue opportunities M&A evaluating and $X.X program. authorized We a potential and has repurchase diligently billion share our business

on therapies to and the the towards committed a deliver are summary, in patients, we the demonstrated maximizing shareholders, bring returns that demands strategy approach to our something investment and progress. short have noticeable innovative we to over Biogen to for all thoughtful past, In continued while As continuing long-term. executed both

in and and grew committed enrolment Our U.S. MS core outside remain resilience. our and so new have we neuroscience SMA. more of long-term as and of of launched initiated in in continued core Europe. studies in areas. our our aim demonstrated in build growth most completed being MS ALS PSP, promising We biosimilars to business portfolio our We depths in emerging SPINRAZA the business and we and care standard the IMRALDI study even to goal develop and grow U.S. to a the of

maximizing in We generated capital allocating we focus neuroscience depths we actively ample on R&D. to cash operating of update patients. strategically will recent the turn in and and over as a our progress portfolio, for bringing shareholder are a I innovative implementing detailed and goal to to build returns a on now therapies Mike again leaner call more develop simpler our model and with

Michael Ehlers

In morning, our leading quarter made industry good differentiated pipeline, and progress important Thank you, Alzheimer's we the including Michel everyone. third portfolio. neuroscience our disease across

webcasts in of patients oligomers, disease and growth and will the will activities Xb available today dose of presented webcast PRIME Phase areas, BANXXXX. month long-term and generally investor on Live our with soluble Eisai of cohort meeting of across aggregated X of the These the XX as disease. regimen include extension Trials antibody oral presentation we our binds of our and monoclonal are presenting section to will fixed we the in depth and profile as amyloid, dementia. Also Alzheimer's and week an These and both the will data fibrils. aducanumab. presentations as a our website. our on be and of The an live month from the aducanumab, from were of disease call and titration This CTAD biomarker present benefit oral CTAD, core efficacy presentations, most on updates areas. dosing to at risk promising analysis and XX So there of study consistent study aducanumab analysis the CTAD available a will collaborator analyses results session emerging build protofibrils be including Alzheimer's results a are early our insoluble at we our the I'm changes forms advances with at a delighted be the clinical Starting programs and Disease or interim website. the Clinical in made the of of review Phase Q&A the prioritize beta of safety Eisai’s Investor previous Alzheimer's well no with

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with diroximel collaboration benefit provide a We or many in oral Alkermes, new fumarate BIIBXXX patients. continue to MS may that as option advance to

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or this an presentations We and presented for sclerosis and strategy. over Committee updates in XXth years are that fumarate in European ENDORSE oral MS data benefits Berlin. which poster the TECFIDERA demonstrate maintained continuous to Earlier patients ECTRIMS our is Biogen multiple study, part at position of Congress our treatment of newly next of the were important the expanding we in leadership committed XX results generation believe month, and the included of in throughout research in nine treatment. from clinical the Key diagnosed

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within disorders. We also neuromuscular momentum see R&D strong

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options with are assessing to disappointed these extent to the the We path are developments [ph] determine we viable and currently forward.

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of detailed to future forum. expect scientific this We study report more a results at

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or the integrin studies and regulation of with dosed phosphorylated Overall of by of a primary beta Xb function down monoclonal [ph] a put IPF. of of first IPF. study alpha patient week this Phase in against In change isolated BGXX the X beta proof v The via as bronchoalveolar in study in on established completed and the of measure X the two in patients antibody rate SPINRAZA humanized otherwise new idiopathic supporting rigorous X Forced patient lavage. data SMAD BGXX of TGF compelling known addition, expiratory patients, portfolio. is biology XX SMA, the STX-XXX, pulmonary and data endpoint clinical Phase decisions a compelling Capacity Vital demonstrated this quarter, by yearly fibrosis make previously measured the first quarter pulmonary in directed the macrophages substantial in driven two standard-of-care our IPF as study Phase continue clinical development across initiated alveolar pathway enrolment this [ph] stroke to in is trials and we inhibition

is momentum lives transforming call I to to of the and continue aim being neuroscience now patients leader to millions the of a building of with portfolio Jeff. vision our neurological the living Our diseases. pass will realize

Jeff Capello

of ex relatively for third OCREVUS TECFIDERA, quarters. U.S., decline levels royalties including were XXXX with increase the included were of million. PLEGRIDY $XXX versus and were saw stable impact a the were the revenues inventory per outside prior OCREVUS Mike. in quarter On were and MS delivered quarter I'll foreign versus our prior royalties. Total for of the Thanks, now stable approximate X% in increase had of Global $XXX XX% third for with Good U.S., Overall the third $X.X billion, revenues billion, on MS quarter everyone. third an versus the revenues rates $X.X quarter relatively of revenues channel third revenues quarter XXXX of relatively review the of in XXXX AVONEX quarter financial stable the and performance versus X% basis, revenues. down X% versus of This first quarter for growing were the billion revenues U.S., XXXX. and $XXX TECFIDERA quarter. starting year-over-year revenues the of MS the the exchange franchise XXXX, third morning, business year-over-year. X% a the for third OCREVUS year increase royalties year. an In in the third a including our our combined. hedging the and million MS revenues. Starting TECFIDERA with Versus in second product U.S. U.S. $X.X million minimal we year

quarter declined OCREVUS. market In royalties sales OCREVUS our has impact the revenues for due by also relative emerging across versus stable sales from U.S. decrease pleased versus $XXX Outside on a performance was it's including X% as basis of were prior stable TYSABRI’s the prior XXXX. emerging included market MS year. moderate certain strong primarily In where towards revenues benefited trends lower addition, very year $XXX European TYSABRI million in though strong, were prior markets XX% U.S., in patients European declining where markets. increased the of world $XXX share. TYSABRI and efficacy except in year. the were were U.S. from This price market Japan Germany year-over-year x quarter, this U.S. third This versus in revenues, million on $XXX each large TYSABRI of we countries. prior by versus high AVONEX a million outside driven and third the quarter, and both the driven the a X% in continues XXXX X% therapy's. PLEGRIDY and versus second versus the Interferon the U.S. now U.S., growth after million over Even quarter first to increased in impacted by performance the the European all in primarily patient U.S. that of quarter XXXX continues million decreases growth launch revenues U.S. wide Interferon important solid outside with the from QX of quarter $XXX OCREVUS. the revenues performance strong third in million patient XXXX. orals relatively revenues we seen Overall, TECFIDERA in TECFIDERA included have were and $XXX of major revenues to market, the growth to move U.S. prior the and improve the TECFIDERA’s year, year-over-year outside XX% negatively reached outside to note launch were ongoing including double-digit decline XX% TYSABRI year. the versus volumes, particularly

the a and stability the expect on we anticipate we less moderate basis significant in continued forward, channel quarter be as year-over-year of build Moving the balance in fourth we the impact through expect a OCREVUS inventory year, U.S. to the

Let me in revenues move number low growth second on compared in of included of the to over U.S., of quarter quarter. as Discontinuations $XXX U.S. the continue by $XXX representing million. driven growth the second Global the the now XX% $XXX SPINRAZA. to relatively end SPINRAZA third to representing second be mortality. primarily were quarter. patients X% revenues The the by U.S., formerly quarter therapy to outside the This compared and and XX%, as million remained compared to increased

are the We over XX% second The a XX% patient patients. now pediatric over XX% of believe are And by of of and U.S. we're progress in estimate now all on an and in adults. estimate to approximately estimate therapy were [ph] very the U.S. approximately continue from the there reached versus in we've In we therapy third infants of third approximately grew have and about we increase that making. quarter. on We we reached by adults, the adults. is adults the number our patients - encouraged the the U.S., quarter in new opportunity XX% in half adults the significant are starts quarter the U.S. U.S. second in

attributed In from indicate the number doses, to XX% patient data the in we roughly believe doses of third patients a of population doses our As In saw We program, quarter. continued adult the maintenance maintenance the second ago. XX% SPINRAZA U.S. compared revenue quarter quarter and of infants, pre-drug benefit from In quarter in are was X.X, dispensed patients highlighting to as the XX% could increase this second X% prevalent the a SPINRAZA as third same of untreated SPINRAZA. units second in third that reminder, approximately that XX% year were quarter XX% per the a SMA decrease from quarter. adults, pediatric XX% contribution are U.S. approximately the approximately are large to and similar our the approximately units were approximately through average the the a quarter.

levels points We the Germany, access to saw Spain, active continue their in of third U.S., discounts Australia. from markets with the due the commercial coming inventory in may prior from to believe percentage for treating increase quarter for patients are XXXB SPINRAZA expanded quarterly third broaden in XX% and international Italy, in recorded there increased Brazil, were XX% be basis allowances SPINRAZA with coverage treatment over revenues the see improved continued XXX approximately relatively maintained versus insurance through compared approximately dynamics the We and to XXX quarter. flat We criteria. of an show in policies expect U.S. recognizing to ex-U.S. primarily coverage We quarter, the as we increased quarter, Outside the a adults, there quarter in is stability versus second pre-drug similar some fourth progress third SPINRAZA If and XX quarter hospitals. program. in SPINRAZA revenue in number seasonal impacting revenue revenues Japan, trends. the the France patients the and approximately U.S., approximately

in also and in new Latin We country American than just but not Asia-Pacific is in significant the that U.S., continued even launches of markets. opportunity SPINRAZA greater momentum as ex-U.S. is international for the we we continue Europe, there believe opportunity and to believe the

We in in rate mature a ex-U.S. more expect to growth revenue at more markets. continued modest although QX, SPINRAZA for see as continues, patient growth

this Let more is exceeds versus the fourth a our believe to launched versus quarter, and HUMIRA the in such be compared week BENEPALI million XX% biosimilars revenue are move revenue Sweden. third U.K., now in XX% available treated markets. leader second grew $XXX me Germany, there FLIXABI which Italy to which Italy. in we countries Europe. Denmark volume mostly the biosimilars by that several in generated our We XXX,XXX now than the in prior continues patients onto volumes Overall Norway increase business, and as year. with biosimilars biosimilar a stable market relatively IMRALDI, now Last quarter, quarter we expect European to share the in XX% referencing and quarter.

drawdown of an with Turning million of third by versus that recorded important the to includes prior in OCREVUS for estimated the We an driven $XXX year, to our quarter note million It's OCREVUS This revenues. the typically inventory primarily anti-CDXX XX% our fourth third royalties. quarter. for royalties RITUXAN. quarter, increase $XXX

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average weighted shares. share approximately third was XXX million quarter in diluted count Our the

our repurchase we quarter, of not shares the common any During stock. did

last debt. rescue net believe ample ended to $X.X $X.X $X.X have to M&A capacity brings board increase in We and $X.XX, booked from return as billion new the our We marketable have We earnings a XX% billion repurchase year and This GAAP versus program. $X.XX, of quarter earnings generated an year. to the approximately development non-GAAP billion our has of third business $X.X per last now share of with we in in of XX% meaningful versus shareholders. earnings operations third diluted However, share share quarter flows capital authorized and per future share. securities and we cash quarter. the billion increase activity, will cash with well us approximately In an and per continue to as

and to comments. for on continue our the disciplined I’ll value to Michel his turn approach over closing creation. will now We be call in focused

Michel Vounatsos

we third Jeff. a last an across with Thank year the and pipeline. revenue quarter progress double-digit earnings ago, new versus launched biosimilar. closed our you, And a week We growth exciting

data beginning that to are regulatory To we remain are Biogen Looking assessing to PSP, the us returning fortify potential aducanumab, benefit to of including most uniquely shareholders. neuroscience MS in forward compelling period to score breakthroughs while we breakthroughs BANXXX in our at the neuroscience updated neuroscience. and X well for the believe approval recent progress across leads CTAD be the progress to BIIBXXX a see capital strategic as XX of capital the and priorities treatment landscape Eisai's in we [ph] these opportunistically focused pipeline, and on believe we in on transformative the from neurological SMA expand leader long-term We aspiration as data Data U.S. in across for for to neuroscience evidence example, the is well presentation deliver diseases. to And including filing MS, week continue ophthalmology our to and next and using the and at MS. our allocate and on of the we pipeline, as executing ALS positioned NURTURE next readouts this Alzheimer's, steps. XX further expect our data within final Phase across the of months,

maximizing reiterate we commitment over to therapies to the [ph] to effectively our patients as long-term. shareholders innovative I bringing continue Finally, returns and our to demands and to efficiently, These want capital allocate appropriately.

making. of As who the super Once we employees to capital lives. strive With we to passion realized our an have clinical optimal dedicated again, And the their participants demonstrated we’ll like I without to on structure, in returns as a open would physician [indiscernible] the thank questions. for [ph], past patient’s programs investment around and and well from are will all in future for not are commitment. our that, achievements the and aim always making we call past, world, be as could have development our impact positive the

Operator

comes the from Your Evercore. Instructions] of [Operator question Please Raffat with Umer line go first ahead.

Umer Raffat

and at questions. asked you I Thank this pay my were Phase Hi. out? in And doses view is, the think previously which and R&D on to by seen Good this, to opt for willing leaders do care BANXXXXs is date, for past based on get Michel, Biogen's we've there Biogen morning. all imbalance on a taking or X way status?. results to I'm reported think you higher BAN baseline your curious everything on a is we've to driven entirely

Michel Vounatsos

question, Umer. the for Thanks

two we but the obviously, in XXth have data the wait seen to Barcelona. have We days for

slide be on a to patient presentation So you. next have Eisai’s the steps. and Please we understand. give we Thank

Operator

go ahead. Meacham Your next Please with line Barclays. of from question Geoff the comes

Geoff Meacham

the noticed you willingness Good the Thank this looking or was Am the and am time X you. first interim prior about And Phase Phase XQ the - related just aducanumab regulatory question. is for have analysis into the take for study, much X too or I ongoing look? a and periods, what versus guys driver that? ENGAGE “final”. on guys. was EMERGE at for to thanks an the X, Phase that data it just morning On initiating EVOLVE pre-planned? is slides reading Hey, thinking the the is I it

Al Sandrock

into main Sandrock. analysis analysis. whether that final reason not we're integrity. to is Al much or do not statement Well, read maintain that help going We're wouldn't about its Geoff, we and to for trial want Hi clinical on an too commenting you the interim understand that I

On the see drivers to for desire EVOLVE, it really not wasn't monitoring driven It MRI our or whether necessary. by was a regulatory request. was

in MRI study it the way ARIA symptomatic or with necessary. is how not the and we're in what ARIA, actually being addressed that's So the we're the the done what monitoring now clinical is, current whether what really which you It's is doing is trials. asymptomatic all is know, - looking study this at being you deal is looking

And so that's the main purpose.

Operator

Porges from Please comes next ahead. question of line Your Geoffrey go the Leerink. with

Geoffrey Porges

X much so Thank my quick commentary Just clarify Type ones. price on couple us taking data Type secondly, by Could your patients Type and And the far? X question, you you performance? market product for give very X, U.S. persistence Thanks. to treatment contribution of you then and a SPINRAZA of could some net

Jeff Capello

Jeff. Its Geoff. Hi,

earlier a quarter in U.S. that on pricing slight pricing perspective the in year. MS, the a perspective the U.S. within pricing a benefit So based our we from products increases in benefited and had from

Al Sandrock

SMA just very and experience, In durable commenting SPINRAZA types. across on types. And on all the of persistent question there's effect a our SPINRAZA across treatment persistence treatment been Geof, essentially

Operator

Please with Your next question comes from the go ahead. line Stanley. of Matthew Morgan Harrison

Matthew Harrison

centered guess, gene with little if gene preclinical pipeline? Thanks. for was therapy more also that this program on Thanks do on clarity you think Great, could product taking the do impact for good I SMA you specifically or morning. on and maybe bit address are your therapy was I the question. they observations what specifically a the going hoping broader

Al Sandrock

comment really would those going we are program interactions. those interactions course Hi, details FDA specific, this ongoing Matthew. I'll but take that interactions question. I really of at I on say point. discuss to mean, we're about won't not

Operator

Your Merrill next Ying line Please of Lynch. America with Huang comes question from of the go Bank ahead.

Ying Huang

can Hi, that comment BANXXXX you extent on X even or for will question. Phase good taking you interact with you FDA filing Phase based not. my Thanks strategy whether To or about can - an for for confirm morning. Xb

question If answer a I that, you SMA. about like cannot to would ask

therapy both their from data on in oral development here? given you does setback leadership and Norvartis future program, SMA, Thanks. that strategy your have a trying to seen the We programs, maintain of Roche change gene about

Al Sandrock

This not right middle regulatory the Al. part. interactions, the commenting so I answer sorry. first first of on that take can't now, Hi. your We're we’re is I’ll in basically question,

Michael Ehlers

and just to I committed be remain other oral highly Roche we commitment, clear experimental programs development. SMA. follow the on We SMA question and the take therapeutics I'll And mean and to completely

have data Type XXXX in of experience is Roche the for in interested presented I roughly nearly that around across patients in six study, aware close the safety that our when data to Type PTC you some patients were X, are I we patients to PTC that to just while look the the are know tolerability on compound. that of of the think field oral up and in We - it it's remind profile say date, would very X I long-term XX know, most had We and as efficacy we years highlights SPINRAZA. mentioned Roche - that clinical XX and really very their interested we. I Type the compound that recent X, would SPINRAZA the of NURTURE instances compelling

largest evidence So SMA body for therapy. any we of the clinical have

Michel Vounatsos

are We in following also filed If penetrating China, I are U.S. seeing dosing. the year see ex-U.S. is in I was we the of unlocking may population this countries wanted U.S., that the Michel. that adding patient momentum first we if have launching. h are in at are plenty may, we we There are the of here staggering to add the effect and just are in the some, and Latin example, unsure this we the in launches in different just we year, population. beginning some idle year And uncertain of geographies at of where the for of beginning the America. in being

We are to doing and extremely core well continue Europe. in well in Japan

[ph] the So that the in the in adult the market implementation momentum but population. again, XX% the has the good, satisfaction is of biggest is U.S. capability

Operator

go of line Kasimov the with from Cory JPMorgan. comes question next Your Please ahead.

Cory Kasimov

Thanks guys. for negotiations? morning, on for XXXX your my wondering the you if MS question. outlook your franchise I comment based formulary Good taking can Hey. on Thanks. pricing was

Michel Vounatsos

the on of magnitude future. and taken in past, in cannot but see to the Thanks Unfortunately able price marketplace we on comment understanding. comment will we be frequency price. not We being for the the the

Operator

And the your Yee of ahead. from Michael question line next Please go comes with Jefferies.

Michael Yee

Great. for question. Question biosimilars. Thanks on the

but on the comment obviously You fourth stable. guess, made a just be your Can HUMIRA are A, comment I that you biosimilar, launching a outlook the biosimilars HUMIRA versus that quarter would you biosimilar on business that? over this business can given years, you're importantly, more Thanks. obviously think some million next few made Enbrel do of then the you've comments you go business? bullish $XXX on And doing type where

Michael Ehlers

the excited pretty we’re Michael, about ground. hit So the team launch, has the already

and see contribution, I in some very in we'll they're the quarter. we well-prepared believe fourth think the

won't in we’re - see lot a as of there those There's also take an of are ramp Europe other on. lines pressure that That's in bit contracts, impact or that know, fourth much a kind some tenders contracts why you two of to You some while big little the across quarter. up. the of pricing

like the to as Bioepis negates over morality before more based get opportunity from we think has a we'd to this - the we'll on and benefit the said get So with to But business next double on relationship a perspective. expect based potentially it of couple kind compounds. of we add years morality

quite growth that So believe we're for us future. about good is this and opportunity a excited we the

Michel Vounatsos

more is left one not launched journey for that tenders in for would there one. this one terms in this and is that those is physician and is So The And the I the from countries well which in pattern big say the two categories. the first purchase set third is the decision entity – Europe, levels. being of the

would stronger. to be the remind biosimilar even are anti-TNFs to strong only that we’ll I [ph] marketplace. that you least anticipate at like having one, we three adalimumab the the as previous company as And So we in the penetrate

up. team supply prescriptions are while and speak we the ready motivated, going So is already is

Operator

go question of Nadeau Company. with from Please comes Phil Cowen Your and next ahead. line the

Phil Nadeau

population. largely does for the on like for another population, have your expectations ask Morning. Thanks want growth a like I in question. PTC seem for to taking one compound and could oral differentiating feature the with SPINRAZA, especially Roche sounds are that SPINRAZA adult from an my U.S. for it competition. key It

So competition those in you patients? see differentiate adult in SPINRAZA – coming the population how how Thanks. and you for could do

Michael Ehlers

in lot So aware on in But teens we – and I'll encouraged data by I other SPINRAZA. the start adults ongoing spine including comment may the in studies we we're Phil, And in date patients, are dose the of are we here out maybe be there. SPINRAZA. in clinical another those. the very there tolerability the We're we’re know long-term the that And essence ultimately We to access, confident safety we It's is competitive have with mean, very staying patients, very - too. that a of early in complex in see what days the used I there. see programs the aware a that of relatively it. and know and of interested will field it's certainly small like orals. selection mentioned but we around of number questions the

Michel Vounatsos

physicians dosing because the real is during SPINRAZA patient XX,XXX together level. with somehow perception were at the efficacy an of past is month able to the we deliver So in there world

was what is for just backed those efficacy comes who patients So its is the and play an this [indiscernible] the customers. convenience by are the after, right being

body XXX for clinical a difficult is with that the more So evidence being still patients than we dosed trial, being. had time patients of to and in XXXX match

Operator

line of go Please Carter from UBS. comes ahead. question Gould with the next Your

Carter Gould

Morning, I for year or versus the question. BASR the just active so on far been this guess obviously, for the pretty BD you’ve committing Jeff Thanks front. for on BD Michel, taking guys. [ph],

be next guess So Thank I may kind you you sort that you. to balance see evolving? see how the how and XX months, just maybe of looking XX out of that

Jeff Capello

Yes.

So thanks the question. for

flow net our think for $X.X you we and cash again I cash cash given So is is position in the generate quarter the strong flows, flow we're of which nice our billion given know, debt position.

able pipeline perspective to invest of both, luxury business to capital return the to a do from in have being shareholders. both We the and

recently eight to love done Michel couple would a the something since been more. and to CEO, stage I new bought mid of type in program But we repurchase that of early also that done. licensing by stage. last is So the to we the in billion get to of over do $X.X We have very so now later encouraged of and capacity just return $XX and remind kind board we've that ample We'd authorized. that the cash shareholders. we’re done stock expect share we - to deals/acquisitions lot have has investors years acquisitions been capital A billion back

pipeline we be do a stage. more that’s we get later and get capacity ample to would more have Certainly done both. the to done in So preference

So kind capacity the certainly have to of we both. do preference, focus be that the or would the but

Michel Vounatsos

is the because because year-to-date, anticipated ago was And of OCREVUS So and biosimilars of if This you Biogen topline to rest. not momentum that P&L. potential here neglected leverage XX% because are. look years the SPINRAZA, at of and launch, if able deliver, not is we the I of am on two with mistaken limited

the within to even in the to very we're we scientific months. IP organization some not level burning more on coming important and rigorous platform very the the rigor and importantly, strategy, a the remained financials to validity, to So readouts alignment and and have of the criteria

tightened we but we're and belt very So evaluating in a best manner. deliver, meantime the we the opportunities, in

Operator

of the with Please from Syed Your ahead. next question Mizuho. go line Salim comes

Salim Syed

the XLRS quarter Al, in the one's deeming on in the guys. looking we're the year? success? are or you you This just Hi, gene Can Mike Thank getting that confirm trial And Thanks for fourth this a therapy you. for probably what still Yeah. for taking data of question. program. terms of topline

Al Sandrock

Yes.

So this. thanks question on for the

know, dependent next in the of timing PhaseX/X subsequent and example This are on the data you trial XLRS The we program these that AGTC. disease ongoing. in right now always we differences no of course, in on adult at But a some could the this interested year kind of subjects. enrolment recall versus right projected are collaborative pediatric is population is is XLRS also program, or for We're a [ph] readout moment get and or So we part that with adult this the heterogeneity. an the very so. anticipating first

in because forth. with of you it location path program you the to track. to need As But - has XLRS know exact endpoints specific and date retina, the kind on visual may pathology the do is of in so of

Operator

line with comes question Karnauskas Citi. of Robyn the Please from next Your go ahead.

Robyn Karnauskas

Hi, Thanks for guys. taking my question.

of think focused or it's potential success from those on the to words, So have that something a come it next for from – like been the to programs, see a is Phase as months, a up proof X. if other In the as the and your to bit, XX works over lot your your stock's Biogen confidence proof like we your with little XX of most these historically you excluding is there which all ability to there leverage indications, that just will concepts we greatest going you are reads ability to a do have that feels presentation – go read - Alzheimer's understand trying pipeline, give lot. real know for on out you're a to

help of So us read least and which those the the understand are have development? the risky next greatest to stage are think you

Michael Ehlers

Okay.

some mean, say program data be different will have, the getting take primarily to early number second case will a do year. as of is the leasing we you target. by we either think so I’d the SODX we the of year we data the that This we an have - different mediated knockdown mechanism with BIIBXX, end or in ALS readouts start in Thank try a there as adult mentioned H this stages a pathological RNase next towards of way noted indication gene I'll of A action of our ramifications. on I across and important for program, the a ASO Michael. that is that. things this different at question. upcoming So I show few pipeline that

But That there other our targeted interested thinking Phase we're potential which positive to study X our potential and efficacy BIIBXXX, tau as genetic CXORFXX as clinical data program Alzheimer's influence ASO likewise biomarker is see currently So to see are the programs disease. has that. like on from ALS, in well the ASO very I I in mentioned like more.

BIIBXXX rare disease. been nuclear is very - our are we a obviously orphan successful in progressive program in We have super severe advancing This policy.

course, that and and year first initiated think readouts study opportunity. we're I us you our an create we’ve array ongoing. kind think that we So we this aducanumab among an And responsive announced earlier others completed enrolment which that That to accelerator study. potential will excitement. really BIIBXXX, know, of know, of month beyond although very Phase its in significant encouraged have of by give - And so we're be ENGAGE this an I could that – in dosing the XX is you EMERGE X data upcoming side. the constitute it's And period

Operator

go with of Your next ahead. Ronny Gal Please Bernstein. question comes from the line

Ronny Gal

Mike you been of analysis AMPA to Can hitting for has or how for you time? first Essentially, discuss programs XXX program. reading early? can quickly, can Two interim you're a potential glyburide you morning, about to out actually pretty Is AMPA this everybody there drug. thank seen there BIIBXXX You before? those is the convinced pipeline. questions of this readout about avoid the second and of accumulate little of a about head Good how potential that that difficult toxicity of something regulator. target this program here? Mike, stroke is particularly you And target kind in. has you [ph] bit on been me with the yourself the thinking one think

Michael Ehlers

we thanks, quite these that different the was I’ll PAMs. AMPA pre-clinically previous were from It safety and clinically. or really was what by quite have profile earlier for try Okay, On pharmacokinetic tight encouraged a reserved and generation questions Ronny been briefly. - both take and profile differentiated really to there and was BIIBXXX

and few seen as that date have in a have memory data as designs and profile, of well of a clinical and to of efficacy indications supported different So studies different the cognition. clinical the domain working been preclinical showing favorable tolerability in

of there this of are compound the we do So pharmacology features some differentiating the previously in others have that class. think specific with versus very to

really is having a patients So won't has investigator there because would I differentiated. alternative talk but obviously on been is activation site that we for we on and very about say analysis hemispheric On think interim site an strong no large engagement, we had infarc. BIIBXXX, that, interests have a response

Operator

Your Goldman Finn next Terence from Please go question comes the of line Sachs. ahead. with

Terence Finn

there? offer I study. then at year. on Hi. that any what about this you heading just point? financials, of the into And biosimilars franchise Thanks pipeline for you operating mentioned to margins the for looks just taking you guys Can guidance for changed then you the just you’ve help like endpoints one XXXX, throughout review bring And that can Thanks. on in the some new think questions. ’XX, course rate continue you can the first the your on wondering - if was lower Maybe the tax us that it

Jeff Capello

Thanks.

a with accounting rate, to to provide reform be around So We you January to low on are We unique when implemented mentioned again release works that at rate, that in running expectation for and world. XXXX, in first the tax got the tax kind how that more script. expect the factors some guidance regard be currently tax more to case come down to of the tax we we'll tax when able a we still our in specific we're that expected XXXX. I the result as did XX% rate as mention of

continue fourth growth commercial a as I seeing the terms in from the a bit drives quarter going know, middle operating you and of to some expenses, SMA. of out we and the spend little mentioned I the and the our up We're we're with for still tick that invest our expect the pipeline can perspective invest money we as through in In the we of to process take of grow with in regard What to on of kind expect our lean back our initiative, pipeline, and of year. and projects share next based to area savings our simple is R&D. G&A strength into of planning you that cost kind

company. in innovation are to we continuing to neurology very committed of the increase So the that

Michael Ehlers

So as interpret it BIIBXXX. was I to think a question I am on XXXX, going that

Michel Vounatsos

Yes.

Michael Ehlers

year head this to again we'll to this or able an anticipate on data just If potentially looking year number on that the approval the next I’ll say from we A BIIBXXX of inform Part the that's the not have first study asking, be in mid file year. expanded against patient but the used to head next Part - study half where we've we B in that TECFIDERA, data patient where of

Operator

line go question the Jaffray. And Please with your final of from Piper comes ahead. Chris Raymond

Chris Raymond

squeezing me another for in. BIIBXXX. question on just Thanks Yes,

could kind strategy here, I think do the unique. on this be launch of Just

under filing pathway, a will BX head to on which about. TECFIDERA you you talked So you versus but head tolerability, have XXX

work tolerability that of of TECFIDERA our that's of bigger Some know the indicates issue. know for you one discontinuation reasons kind you of

So far if address sort essentially you TECFIDERA. seen of big we've data that clinical should a so repeat the know, issue of BIIBXXX

on this think drug should you we do also marketing approach point, how that of positioning guys over two just that second you and you Thanks. heard of how timing? So And guys sort coexisting in mentioned or time? you can then XXXX I these talk that I just maybe drugs slide think I and about approval, about talk approval, about a the but half your think XXXX

Michel Vounatsos

And I the would are great first Thanks with we behind for like question. say momentum TEC . to that pleased the the

important. is this think I

TEC remain So always will center. front end

We price, like grow increasing even have crushing face the well. Europe of pressure we if are some competition. We the in world doing we part and volume in we

and eventually management the to have in offers will safety offer GI move the hanging eventually of to lifecycle will opportunity and BIIBXXX fumarate. term longer towards the safety that an team fruit So the low further. a product be profile beyond the aim opportunities that this upgrade working terms And we is these

to expand market. we are is But very on. this working of opportunity excited we're orals, about leading So beyond and share fumarate the what but our

launch potentially So looking early towards the ‘XX forward of XXXX. end or and to filing this

Michel Vounatsos

to are times this Biogen thank a saying you Have close good we a call data our I looking that call I very readouts by would the forward all exciting to stage, at today. day. the and for like attending So

Matt Calistri

Thank you call. for today's joining

Time. I to like that would Eastern CTAD webcast this everyone we plan October at Before conclude, a.m. XXth Thursday on week, we from XXX host later to remind three

Dr. Budd Friday October you we we with webcast a Medical patients will can and the webcast Aducanumab. our presentation those Time website presentation Alzheimer's disorders Later stage from you Samantha we day Thank webcast titration at X:XX at and early forward The to Haeberlein, X:XX regiment, development, of portfolio in to Xb dosing Vice section Time the disease. Budd study discuss titled Q&A be Eastern at will learned clinical and we Investor Alzheimer's XX We with Samantha aducanumab keynote XX titled a.m. disease, to President, links Phase Haeberlein Chief movement Biogen’s Al Alzheimer's Sandrock, the dementia host webcast oral from in look and Officer later from with future. on what found month analysis Eastern that an the will on PRIME, speaking www.biogen.com. Investor p.m. the

Operator

may attending now and This to you today's will call conclude disconnect. for everyone you today. Thank

Biogen (BIIB) 23 Oct 182018 Q3 Earnings call transcript