Biogen (BIIB) 30 Jan 202019 Q4 Earnings call transcript

Good morning. My name is Carmen, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Fourth Quarter and Full Year 2019 Financial Results and Business Update. [Operator Instructions]

Thank you. to conference like to now would turn over the Mr. I Vice President, Mara, Investor Joe Relations.

begin. may You

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

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

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

also discussions that have We this on our follow related our the website call. posted slides to

forward-looking and based our detail. materially. to and may I risk would like I These to beliefs. uncertainties additional point results you out SEC filings to which making and current on statements, certain expectations that differ for encourage are be factors our statements subject we actual risks discussed in the our are consult will

On our Officer, Al by Dr. Vounatsos; and Chief EVP, Capello. I today's Research Jeff Michel and Sandrock, am Development; Executive our call, CFO, joined

will over I call to Michel. Now, the turn

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

quarterly $X.X financial some Biogen First, start ago. the year let compared me with same billion, of to closed revenues XXXX X% highlights. increase with of an period a

$XX.X revenues, growth representing year-over-year. in Biogen billion the full year generated XXXX, For of X%

XX% share, year non-GAAP Full full a versus year increase earnings share, XXXX a a year increase $XX.XX XX% XXXX. XXXX. GAAP a $XX.XX year were were full Full XXXX earnings versus

in our execute as growth, we strategy strong to are We the pleased for leadership long-term with on neuroscience. year-over-year continue

year. the Now, let me review

X% markets, our X% emerging as an prior OCREVUS $X.X resilience the mature billion, in European versus the The increased in prior all the of globally driven business our MS markets, revenue, and royalties, First, number patients versus as full strong growth of increase MS on large including patients the year, by year demonstrated US. products year. were of well

an remains increasingly the an level launch, early team demonstrating Our pleased It executed are the We from in of well, important we has market. as treatment patients interest crowded to compete and far, new option. with oral in the launched in so but VUMERITY our physicians. ability US

patients SPINRAZA the of XX% treated Second, program in global full versus with year was by and This greater being billion, SPINRAZA. strong prior revenues XX,XXX US. year-over-year over a blockbuster expanded the generated year. the now increase even Including access $X.X growth clinical are US driven outside growth revenue revenue and the performance trials,

in $XXX as financial million, work system. EURX.X Third, we for that to and full XXXX, approximately create biosimilars IMRALDI. biosimilars year the to to generated long-term billion contribute the European healthcare systems expect increase innovation estimate by savings critical to driven year-over-year, is revenue which growth was we of our This which XX% in We will represents of XXXX. continue sustainability headroom the healthcare primarily

a Samsung our the commercialization including, significant us in our bolstered markets biosimilars in This two new with biosimilars in access the well anti-TNFs rights transaction as with first in to also potential to quarter market Bioepis. with worldwide, new biosimilars We this as China. time, provides US, for ophthalmology a business opportunity major

for R&D an was this year Fourth, historic organization.

scientific We therapy patients, community, for for of disease. can of are and have reduce what decline clinical may inspired physicians by decades mean waiting implications data positive Alzheimer's a aducanumab that been the the the who broader the

and Europe as as forward and completing are actively a soon as filing we Japan, well as engaging in with We regulatory regulators US the in look to FDA the possible.

ethics have the we re-dosing and the initiation. are committees FDA, successfully progress with currently study, as protocol been has the important and to working there In submitted to we towards sites addition, study related the

and to program and for continue MS, adding in BIIBXXX we new with aducanumab, lupus, in ALS, the ophthalmology for and our creation, clinical we data we positive we near-term our brain believe contusion. and years R&D, Fifth, readout most potential prepare value in seven for in progress in opportunities have early was pipeline one multiple US, beyond XXXX approval as Parkinson's launches a VUMERITY of for productive expand multiple XXXX. disease, the

Sixth, approximately approximately an generation Throughout and the we versus to with year, billion. to $X.X the and XX% flow $X.X strong XX prior approximately capital. repurchased of flow shares billion value total allocate operations, us our for a cash in In generated million continue increase remains flexibility of optionality XXXX, provide cash year. we approximately significant from

view stated have As we continue the the to important value-creating we potential external development capacity and financial business capital opportunities. evaluate and thoughtful of we to element At M&A have same flexibility and time, an previously, share as repurchase allocation.

over our Alzheimer's development Over disease. the with three contributed we executed deals executed both have years, which transactions, a and symptomatic past in have the potential months including XX three We with Parkinson's proposed Pfizer past therapy significant [ph] application for disease expansion alone, four of business our pipeline. the potential transaction to

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

to we a executed Biogen as was and our and progress. productive noticeable very summary, continued year strategy In for deliver XXXX on successful

Our therapy XX,XXX grow in demonstrate new a VUMERITY. foundation we of SPINRAZA and clinical to even remains of and geographies. core with data US, over patients to SMA. launching of more body care in excited in so MS expand be patients the the US to revenues, SMA, resilience continued as are to we business largest into on and and outside SPINRAZA in continued both the continue With growth

and our presence. geographic biosimilars We grew expanded and business, portfolio our we

are to Alzheimer's for for in we We fight against US lead filing aducanumab. as preparing a plan disease the

strategically in maximize shareholder lupus. positive And Beyond allocating readout our on with we pipeline the data programs aducanumab, as flow we to over expanded cash and clinical term. and generated capital new ample return progressed we focus long seven a

I over R&D. to Al recent the progress will now turn in detailed a more update our call for on

good everyone. morning, and Michel, you, Thank

like will aducanumab. Biogen at Canada Europe launches, and extensive positions crucial Medical, Medical, I to therapeutic in Sanofi. I XX and Dr. Chief a held Biogen. Maha's Maha range than as Medical previously She of geographies Bioverativ more here of potential pipeline we of the new Officer Radhakrishnan broad medical Vice including Vice Before President, prepare senior President, US for as experience at background and with in would future back years at as launch across affairs subsequently Maha begin, brings be areas. welcome multiple worked and us the

discussed, Biogen. a for year was XXXX Michel historic As

In biologics, clinical includes antibodies, on addition multi-franchise programs for we portfolio and building positive small by made III. adding seven results to Phase aducanumab, to announcing Reflecting approval advanced pipeline two modality-agnostic advancing molecules, and VUMERITY, programs on therapy. our gene now other antisense approach, significant neuroscience receiving progress oligonucleotides our a

quarter, Alzheimer's from At of a in held three of pre-specified Boxes, Final turn Clinical me analysis CDR on of and results line Let on to that the Alzheimer's the significance primary Trials III now Diego, or dementia. positive well endpoints. the disease. Disease, CTAD, all on aducanumab the regimen pre-specified starting presented top both Alzheimer's advances studies month the these high of as as last achieving Phase in was early we with meeting made Sum San dose disease secondary in study EMERGE fourth we statistical showed endpoint with a aducanumab data of annual

the from by regulatory who On do endpoint, we primary expect of note FDA. findings the a the patients do other that decision aducanumab believe ENGAGE support although not we hand, achieved prior not additional study data data to aducanumab from dose exposure did to the data present high Please meet on that ENGAGE EMERGE. the to in sufficient

said, FDA, we the the working with open-label as the Aducanumab as Michel As study to support are initiate soon possible. re-dosing of

FDA, infusions the submitted with kilogram studies, titrated treated and weeks. the have will this the working aducanumab study study, clinical four committees previously to are our patients placebo, currently XX with aducanumab We patients enrolled ethics sites successfully in be either In per every including milligrams and we previously protocol or initiation. towards eligible to

In I; anti-tau oligonucleotide advance tau-targeted distinct a of next III Alzheimer's in year. addition Phase II continue an we a I; antibody study antibody to to in gosuranemab, Phase Phase antisense anti-tau BIIBXXX, broad for expect which including a the Phase and disease data in BIIBXXX, portfolio, aducanumab, BANXXXX; we

but positivity amyloid develop the for partner threshold continue to prevent to BANXXXX impairment. the Trials disease. AX placebo that in high-dose Clinical very study to earlier cognitive little Together, cognitive amyloid even show aim evaluate As studies amyloid for but AXX. early Alzheimer's BANXXXX clinical Alzheimer's AHEAD evaluate XXX the the no Consortium, The below will onset decline portfolio, in positive potentially along currently these our can initiate our studies to comprised versus AX administration at are termed end, evaluate of into XXX who The we AHEAD of individuals BANXXXX the accumulation. or collaboration placebo expand stages two Eisai, risk populations normal individuals AXX in whether disease. of is the accumulation cognitively high plans study to we slow Alzheimer's with To amyloid of and low-dose who will are will are versus [ph]. patient further

of tolerability MS. meeting TECFIDERA, the novel Turning journal, forms FDA that to month. treatment Detailed GI November VUMERITY to published by were for was a patient-reported fumarate, MS annual announce compared the the and the we in directly from Drugs, which were relapsing and and Charcot of approved oral the quarter, results VUMERITY, study, EVOLVE-MS-X neuroimmunology, of at European Phase this pleased earlier the Foundation this in of II presented CNS

Specifically, of Individual X self-reported showed on data days XX% scores at the patients with primary with the fewer on endpoint, least treated these VUMERITY that intensity

result Scale was offers was who Consistent compared of proportionate X.X% TECFIDERA. for TECFIDERA. tolerability a statistically Symptom compared events data VUMERITY the adverse with these clinically in to for with with to TECFIDERA. Gastrointestinal GI p-value discontinued these Impact indicate and X.XXXX. data, the a study This improvement Together, due that patients significant VUMERITY meaningful GI and X.X% highly

remyelinating advance inhibitor I; anti-LINGO portfolio, a middle in Phase an and our an the BIIBXXX, this II continue Phase opicinumab, we in oral BTK expect for Phase Across data in BIIBXXX, which antibody I; MS to we oral year. agent of

new Moving medicines for lupus, with are and limited, progress unmet both remains are disease. medical manage needed lupus there to chronic this people for and options living tremendous immunology, difficult-to-treat need Treatment forms. to systemic and our including a cutaneous in

in builds both work immunology, that collaborations. history has long and home-grown on assets lupus Biogen in including Our a

quarter very We This this to two-part Biogen, of from report potential by study XXX,XXX a developed that GX. affect active antibody of first-in-class in cutaneous excited study with forms and the individuals individuals discovered evaluated data were two II in placebo total BIIBXXX approximately LILAC lupus Phase positive a the BIIBXXX, anti-BDCAX in of versus lupus

systemic BIIBXXX reducing primary manifestations, and p-value endpoint tender systemic lupus study or without XX. or SLE its on with the its skin swollen than With SLE, measured with manifestations. score from or and in CLASI-A at active joints significant change of CLE, a of total joint endpoint of the CLE change the in less baseline the individuals activity X.XXX, baseline or the Erythematosus, study primary part statistically in week of week by from number with demonstrating XX. erythematosus, a met part met response The also by percentage of disease as the at of

total BIIBXXX XXX significant patients of experienced X.X joint study, this In counts treated placebo. compared to a reduction of milligrams with statistically active

BIIBXXX The skin we were safety Phase In endpoints. overall planning disease to move its addition, disease continued support consistently and improvements development, of and to are secondary forward III. activity across observed and tolerability in multiple

that R&D important of elements believe at Biogen. our to approach program exemplifies the We BIIBXXX broader

clinical to of serve concept able I, were de-risking measure in we and Phase success believe II in by engagement increase of programs a example, of early and biomarkers generate were of development, biology probability proof Phase our of We clinical a data target such For compelling may implementing preliminary the confirmed that to subsequently proof of data portfolio. in other well-controlled study. which strategies across efficacy

tofersen, oligonucleotide International Center in as our month, ALS/Motor CSF tofersen, at Neuron last and in demonstrated at ALS Massachusetts Hospital, study Phase three antisense Ionis for ALS. Center disorders, the ALS. award of SODX on were Biogen, were Pharmaceuticals Symposium decrease pleased awarded collaborators the neuromuscular this significant to our to Prize of Disease, the and discovery compared trends placebo. the Healey contributions the by of Innovation this statistically to At final by levels and Presented the independent towards protein from our we meeting, International General decline data development In which clinical slowing SODX I/II for a measures present assessed recognized

both in and Furthermore, of levels CSF. plasma with tofersen reduced neurofilament treatment

We are the encouraged by genetic target disease. potential generated clinical data, to sets and antisense of of drivers neurodegenerative the in broad and target across data the oligonucleotides concordance neurofilament including study, engagement,

We study VALOR expect data III year. from the tofersen of Phase next

an continue the we of CXorfXX-mediated to BIIBXXX, studies Phase XPOX I addition, advance ASO small and In molecule for sporadic a of for ALS, inhibitor BIIBXXX, ALS.

and REPX GX enrollment to therapy an quarter, inevitably currently the BIIBXXX of in rare retinal completed of the affects in REPX. we encoding aimed of the disorder Choroideremia caused underlying in Rab gene AAVX-packaged no gene this is blindness protein X, Turning address by approximately X-linked treatments. expressing approved BIIBXXX Phase and ophthalmology, function STAR the to leads choroideremia, in III that inherited to this by XX,XXX a escort loss study cause mutations individuals disease is or transgene. a has

rate vision natural treated studies, I/II higher of Phase In history. maintained a BIIBXXX to demonstrated compared with patients

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of only letters XX the observed compared one least natural at BIIBXXX as study. patients X% to improvement treated in history XX% demonstrated Specifically, of at an with year,

generally The profile. an safety BIIBXXX I/II also studies was Phase demonstrated that tolerated well with acceptable

to signs look III We study this the data end are efficacy toward safety Phase forward of early of and these the year. encouraged by and of BIIBXXX from

We in are advancing of with Phase the data year. XLRP middle BIIBXXX of II/III study expected next also the in

the In study IV for or glibenclamide, of to with continue treatment reduced edema, over LHI. look in XX%. XX% by reduction by Phase of to hemispheric data study by from caused cerebral and of LHI BIIBXXX with stroke, BIIBXXX, year. next Phase We III a imaging we midline large of cerebral or edema the shift, in II Phase associated a advance was BIIBXXX study, infarction, III an measure the mortality end In forward

study candidate end for TMS-XXX small are study has following II year. that Phase a the this TMS-XXX of expected this of molecule acute stroke. the progress. from continues to of become drug addition, ischemic Data by to plasminogen potential In modulator thrombolytic is a the patients best-in-class an

the Parkinson's cinpanemab, to BIIBXXX, disease, II I Phase we disorders, of antisense Phase movement study anti-alpha-synuclein the or year, advance LRRKX. as Within an with continue well data BIIBXXX, for oligonucleotide second an in half for expected this antibody as targeting

the study The for the primary we reported Last PSP. of PSP and not met, Phase was gosuranemab PASSPORT month, and top tauopathies. primary for line therefore from endpoint II results we discontinued gosuranemab development other of

in the disappointed the were we result, in to given we study disease differences chose While pathophysiology. potentially significant Alzheimer's in early disease, II this Phase continue gosuranemab of

data schizophrenia. half AMPA a next study an And expect in of advance -- continue impairment to II disorders, now We receptor we Phase for potentiator year. this neurocognitive of year BIIBXXX, associated with study second the from cognitive in this of

month, encouraged injection a by approved therapies agreement XXXX selectively with alone. we the macular demonstrating CX, Finally, preclinical And of a CB X Biosciences single ophthalmology, approximately last affects protease age-related for productive atrophy, advanced that of to novel days. cleaves for from we of is GA in develop we that pegylated further to XX an the vitreous least individuals GA. eliminated Building development no the over molecule humor target treatment and AMD. or into at a is business validated are million US entered genetically Catalyst on in in of This CX has XX% data intravitreal or protease this leads had degeneration, blindness, depth commercialize form dry the AMD, and a potential that front. geographic quarter an

collaboration a a potentially Circuitry Therapeutics to In addition, disease. quarter, neurological identify Gene of signaling CAMPX with their role Platform leverage to a in initiated microglial play causal targets to suite druggable pathways this known in we already

And in of patients XX% severe of disease. a Parkinson's disorder, of anxious contribute by later and inhibitor ISWRD key CKX and to this X, I living. Sundowning agreement small an is with we as sleep, become profile difficulties of or activities and molecule confused, demonstrated safety acceptable novel a AD fragmented regulator which characterized approximately -- an symptom proof most well Phase become Parkinson's and causes the in mechanism. casein in Alzheimer's acquire disease, to sleep-wake patients study ISWRD, CNS-penetrant recently, agitated Pfizer. fatigue sundowning can is announced daily or as of day. rhythms, disease, to affects Phase study, irregular dysregulated non-motor Ia a from CKX, rhythm a circadian In kinase molecule of and

study circadian this melatonin a a and treatment was increase of closing symptomatic phase initiate the Phase PD, XXXX. significant first a an close to for end is there Specifically, to expect concentration, and This to it innovative expect we believe dose-related customary of modulation. AD salivary in the year. subject and represent marker we We transaction of conditions, by both Ib this in may statistically and quarter

a living delivered programs, Biogen plan are II Phase nine with III, in ahead including in develop aducanumab multiple and potentially With Phase in as across multiple Phase company with in to strong position deep US medicines pipeline Overall, XX is opportunities clinical in modalities. of breakthrough progress believe significant XXXX. in additional preclinical believe no well programs us, that We diseases. and positioned with today I, our R&D XX we a other near-term to the we six devastating for file neurological patients

pass over the to now call Jeff. I'll

everyone. Thanks Good morning, Al.

financial more guidance for now with XXXX. performance share provide our our you me detail on and Let for XXXX

revenues. with start Let's

X% for revenues full Michel billion. strong for As QX core $X.X grew X% all billion performance across grew a very business we to approximately XXXX the our earlier, the fourth in to $XX.X Total had year-over-year year and mentioned quarter areas. of

quarter million in $X.X business including in quarter without we OCREVUS $XXX channel revenues X% XXXX of million in build first of fourth an revenues QX delivered following year an and compared of XXXX QX billion in the quarter, revenues of Based approximately the inventory $XXX see channel decreased royalties. royalties of in $XXX in our increased the MS inventory million. MS decrease OCREVUS versus on benefited to of approximately increase of OCREVUS year-end a typically royalties approximately X% MS inventory. XXXX, increase prior results, including US XXXX. from fourth historical in Overall,

OCREVUS X% prior versus year Full including the without revenues OCREVUS prior and $X.X year revenues versus royalties million. year OCREVUS increased decreased billion, MS MS were Full $XXX of including royalties year the approximately X% royalties.

fourth Global of a in approximately of Throughout TECFIDERA total X% our million in $X.X XXXX. prior the increase US, of of increase quarter million the XXXX, the QX billion, versus in in of of quarter XXXX. an $XXX in revenues versus $XXX channel stability TECFIDERA increase $XXX were compared an This share the increase XXXX million inventory included from pleased US, for the QX quarter we revenues the prescriptions the an in in X% versus fourth year. benefited XXXX, TECFIDERA XX% outside to US. of and relative of US fourth to increase of approximately consecutive quarters four see million $XX were an

versus recorded revenue, performance of and fourth US QX Latin channel attribute addition America VUMERITY approximately from year. US, major TECFIDERA, and in all in patient in launched prior again European of we in to Asia and with loading. all to late we Pacific the well growth In patient strong which quarter $X the performed markets XX% in Outside the very million strong TECFIDERA the growth

of billion versus $X.X $X.X billion, This TECFIDERA the US. sales were worldwide year, year. and the X% in full outside the in prior included $X.X the billion For increase an revenues US

a shipments. quarter, dynamics versus $XXX both Interferon million US included timing million decrease the platforms impacted US in to fourth including shift of oral injectable AVONEX $XXX XXXX the and from This were PLEGRIDY, of in therapies. and million revenues, by a $XXX outside XX% outside the US. were QX the high-efficacy channel the during and negatively continued Interferon to sales due or revenues

$XX $XX approximately US, million channel increase benefited the PLEGRIDY compared inventory QX of increase and an to in million XXXX. AVONEX an Within in of from approximately

full $X.X consisting US. interferon US to worldwide decreased For revenues billion, the year, $X.X sales the in outside XX% billion the in million and of $XXX

included were In prior $XXX $XXX versus worldwide fourth an revenues quarter quarter revenues X% This year, consecutive US, the performance XXXX. quarter, of the year-over-year this million and versus million TYSABRI the fourth improved $XXX on X% million of a US. US representing increased of outside in increase the basis. the

inventory an levels compared the for relatively approximately US, in fourth of of increase Within million quarter stable $XX XXXX. were the TYSABRI to

in share of were impacted were XXXX, the see relative revenues versus year the shipments. by and revenues decreased Throughout TYSABRI timing X% of the dynamics total prescriptions pleased both as stability in prior to TYSABRI's US. we Outside channel new US, and negatively

$XXX $X.X full worldwide X% TYSABRI of year. We were the of US billion For year, internationally. versus revenues recorded $X an prior million revenues billion, increase and approximately

were we of pleased maintaining MS in very market. focused the on Overall, resilience XXXX are with of of the and the new entering business competition our light this performance in franchise

QX on XXXX. move of US, million, a for the revenues both prior versus an XXXX now $XXX Global $XXX relatively In were third versus SPINRAZA. SPINRAZA increase fourth the and X% increase of million, flat year QX XX% and quarter. XXXX fourth the the versus me were revenues quarter SPINRAZA Let quarter to

patients quarter XXXX, the compared growth with the and to of coming both therapy third segments. in X% number The the on as end increased from patient adult US pediatric of of

the new overall starts in in exceeded QX adults, We more continue And our adults. patient than to as strong of XX% were make growth with progress adults growth.

the the adult market. largest segment of population is the As reminder, a

from We SMA an infant the X% therapy population, to see approximately the impact within gene total have of represents market. which continued

regions, and decreased Outside were in of launched prior the quarter US, X% across the XXXX. approximately SPINRAZA year quarter. Despite a versus the increased of growth mix, quarter this the overall the US, The growth, newly strong decrease increase of strong a ex-US shipments prior the fourth an saw quarter $XXX commercial due both all in XX% certain of XXXX existing slightly SPINRAZA versus from country fourth and quarter the revenues pricing revenues of versus year in we XX% patient countries. markets million, patients third dose and of of Outside of the to broad loading with dynamics. versus combination growth SPINRAZA third dynamics, number patients timing

with saw as Overall, growth performance continued across strong again the we SPINRAZA's and quarter, patient emerging this the mature pleased we were large in markets very markets. uptake

XX% outside there than came reach outside significant our more the opportunity particularly and additional Additionally, of revenue US. patients, from US, to the remains

full driven worldwide SPINRAZA in For the XX% by year, revenues increased to X% to million $X.X and XX% $XXX to outside US US billion, growth growth the $X.X billion. the

to move of anti-TNF million quarter, three XX% now prior which approximately the growing me biosimilars, which a We more prior treatments Let XX% increase that year. estimate we versus on our revenues receiving than patients business, XXX,XXX our the with is $XXX biosimilars have generated versus of significant this year.

such in BENEPALI IMRALDI Germany ENBREL and biosimilar leading Italy. the most FLIXABI major is And as prescribed the the is and is HUMIRA the Remicade the biosimilar biosimilar Italy. markets leading UK in Germany, in UK.

For grew revenues $XXX the year, XX% to million. full biosimilars

of Turning prior saw $X.X In a entry first year to billion, XX% revenues XXXX. an by the million the XX% anti-CDXX the increase OCREVUS primarily increase we $XXX quarter, for of anti-CDXX our RITUXAN royalties. fourth biosimilar. we a quarter, Full recorded versus year, driven fourth were revenues, versus the

every reminder, year. royalty which on US our additional put as OCREVUS will rate entrants We resets of Also expect sales we in on further expect calendar RITUXAN a biosimilar XXXX, pressure revenues.

for fourth due a in decrease the prior timing revenues of XX% to Total an the million Other quarter, million XX% versus $XXX XXXX. versus shipments. the $XXX year full of revenues were were year, other increase of the

to benefited other a of the reminder, quarter from a one-time first shipment As in XXXX revenues large Bioverativ.

that and difficult variable predict. revenues to addition, In are other note

the me The margin in Let were relatively of compared royalties, as related well of approximately gross to revenues for performance. XX% XXXX margin fourth was XX%, to QX quarter versus XXXX year in due margins gross to improvement the now XXXX. slightly lower lower gross margin XXXX. Gross full to other cost flat approximately year our revenues. turn full as was XX%

related R&D agreements billion. $XX year revenue $XX or QX and Ionis expense the related payment BIIBXXX, million and and QX the Therapeutics of opt-in Catalyst GAAP includes R&D to collaboration R&D CAMPX made Bioepis, Biosciences. with million. transaction GAAP and of to Full non-GAAP XX% related was XX% with million expense was million expense to $X.X to Samsung our $XXX revenue we $XX non-GAAP or

revenue QX SG&A expense non-GAAP SG&A increased was or commercial million. SG&A GAAP billion. XX% and the of well XX% non-GAAP Full billion. quarter, G&A. $XXX spend on and XX% as of expense $XXX Both or SG&A increased was GAAP of QX as due of XX% or SG&A the sales timing prior million. to primarily revenue sales medical investments, non-GAAP GAAP was was year year $X.X of $X.X Full or versus

investments, expense the gains income million The year. full driven GAAP by GAAP and difference for the for million as is was which GAAP the other in million expense, fourth results full $XXX and these was and primarily which Non- $XX quarter, year. non-GAAP includes only. was classify interest, $XX fourth million we strategic the $XX between in quarter on

XXXX Company's the XXXX. remaining benefited inventory to prior-year the due inter-Company Furthermore, effects. in and of from full the tax also to reform unfavorable rate the the sale US year the prior for in higher-tax both GAAP rate Compared tax tax non-GAAP and In XXXX the fourth year, quarter in effect the a GAAP GAAP our of year, change non-recurring and the XX%. approximately non-GAAP from in was of full fourth profile rates XXXX quarter portion of the and and benefited tax

an for total and weighted for year. a Our value shares diluted of approximately approximately $X.X approximately at was total count fourth including billion, the share quarter $XXX full Throughout million XX XXX shares $X.X the average billion. a XXXX, the price quarter approximately approximately of we approximately million X.X fourth million of XXX million for for in repurchased average value

our in diluted of end the $X.X we outstanding, by Board XXXX, plan earnings the As a which new authorization share. per billion the now had total the billion repurchase including brings to December year, $X share approved of us of approximately in

$X.XX, In non-GAAP the the fourth XXXX, booked of increase earnings XX% fourth XX% GAAP $X.XX, year. of of quarter, versus prior and EPS quarter per of increase versus share we the an a

year, GAAP was XXXX. a $XX.XX, increase $XX.XX, increase and XX% EPS XXXX, full versus the a versus For EPS XX% non-GAAP was

$X We cash marketable in in year approximately year, by $X.X net in with quarter billion approximately the billion and full for securities We to operations marking impacted and approximately final $X.X from the flows cash and billion Fumapharm. generated where cash payments billion flows the $X in ended are QX debt.

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

approximately billion anticipate to of GAAP revenues. revenues XX% and $XX be expect non-GAAP R&D and between to $XX.X We of XX% expense We billion.

SG&A expect expense be We XX% and XX.X% we for per non-GAAP results and anticipate to and earnings earnings year $XX.XX. be approximately per non-GAAP revenues. to to between rates $XX.XX non-GAAP diluted GAAP anticipate share full to XX.X% XXXX be XXXX between We to our to XX%. of And diluted GAAP of tax to $XX.XX share GAAP $XX.XX

This with It's important assume are transactions, our does to predict. hard Pfizer business not or impact does both development note that to potential closes. this proposed guidance large from guidance transaction acquisitions any as include

to quarter also the exchange foreign off no assumes of rates. guidance Our count a fourth XXXX change stable share and

an mid-year guidance and the XXXX in of reminder, This earnings assumes now. assumes generic a and will call. best expenses aducanumab. as our provide Importantly, for US second also related commercial our in as update on we our to guidance competition R&D additional quarter And no TECFIDERA reflects assumptions

Michel for to comments. over his closing back call the turn now I'll

growth earnings core ago performance all double-digit areas, and our growth each We versus our XXXX year pillar Thank with business you, of of a strategy. across across execution strong delivered Jeff. strong in

to across priority well and SMA, with a aim on our continue biosimilars by priorities pipeline, our executing For on strategic our aducanumab. XXXX, we MS, momentum

We initial thorough a on implementing out our potential aducanumab of are and US. sales focus model, teams the preparing for preparing the includes launch This with actively access. the an force, go-to-market market hiring medical for building

are with In Europe the of we actively and engaging regulators addition, including Japan. outside US,

increase XX just pipeline Phase and XX programs is now Beyond an have maturing. six aducanumab, programs years clinical our ago. III in We from three overall,

and tofersen readouts III MS, data and disease, now and ALS, to Alzheimer's choroideremia we the Parkinson's ophthalmology, multiple for II stage near-term Phase ophthalmology and acute disease, XXXX, schizophrenia, build in end value expect large disease, infarction, hemispheric we neurology including Alzheimer's ALS, portfolio. a readouts, multi-franchise in neuropathic in and stroke, opportunities have Phase We Between of as creation, BIIBXXX including pain. for biosimilars, aim eight XX in mid-to-late lupus, BIIBXXX readouts across

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We will now the open questions. for call

question Geoff [Operator Instructions] the Please of comes go from with Leerink. SVB Porges ahead. Your line first

and much, very all the you on progress. and congratulations Thank the quarter and results the

are in that, have budgeted your built risdiplam Thanks. on Could effect sales full the the fully that launch also you into guidance Just you about what assumptions guidance. a imminent talk couple for of and the but on everything mentioned it guidance? questions, launch force is SPINRAZA? incorporated And aducanumab? of the costs just you about Your Jeff,

the So questions, thanks for Geoff.

we assuming risdiplam, are to regard with that that launch. product So does

We'd kind is, have discontinuation of very that very, kind so rate. to remind we're and XX,XXX a everyone low means. people therapy well people see anticipating, data very we else as just what And it today the on of doing with

So we'll us growth for of see kind lot of is product received. what that ahead. happens on the data and how certainly, a But opportunity there's

that but specific perspective, you from and just I the SG&A of to prudent relative ahead of guidance, is quite the looking perspective that thing amount we're regard we up percentage And back given numbers which bit to we're of we're is to terms to about. which year-over-year significant you do, the at excited to on a aducanumab, With I think get a last would that the spent us, point the quite launch, opportunity give year. in going not sense a spending

from line the Flynn Sachs. Your next Terence question of with Goldman comes

two Great, for for thanks the taking just question. Maybe me.

you filing. us if gating you the you are in in of of confidence both to the And regulatory there, ex-US terms filing then give have the filings in expecting in And can the Europe a Japan do wondering aducanumab level Thank similar as on do then, Just detail outlook in you. US? a any priority what's you more review?

matter Al. and all basically Document. It's a FDA. that the together submitting that etc. Common putting is with documentation, assembling of electronic this Terence, Hi, electronic to the an of document It's hyperlinks, a Technical matter It's

a engaged Type I engagement -- And with level been unique there this meeting I've industry. I'll It's high first C a the been is last last engagement, say the of think, the constructive been June. -- it's in of to last since and never been constructive. them June, very terms But unusual, we've it's pretty since ever me. across has that situation --

will And point. those at with at as anticipate well other other respect but still But early in we point our engagement some some with regions, them, filing we that days. it's be regions the to we do started have

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

Good results, questions. morning. for you the taking and Congratulations the on thank

to trial. Essentially, that got when what the protocol, that? are trial. trying bit if You mentioned what you've achieve I from the can with wonder what you're -- about tell that see a the us that beginning now just should data you're endpoints you we is to -- and the little redosing

do little then on commercial launch step intend you make Can And to it a plans whether bit yet. a give didn't second can the really bit VUMERITY, talk describe here? it little you you about I guess that of be there things parity would VUMERITY or will -- Or kind model in than that of to access, be you some TECFIDERA? same worse so terms business TECFIDERA? with and the support forth, better

humanitarian the Hi helped for felt develop to reason of clinical had our reasons. study redosing Many We aducanumab. They something had investigators be Al. the the had Ronny, them studies. we all these wanted volunteered were to a main it's The in drug. desire who they expressed that to them. owed patients us We

that's the So reason. primary

long-term were all can had a my who prior studies, envisioned is safety doing As that kilogram thing we aducanumab, single-arm and extension I up in that at patient every Basically, milligrams my really a and per including And notes eligible. main tolerability. said titrated in gets placebo study. -- always study, patients are you XX look single-arm script study. in a In patients, it's the to

had place in tolerability. fact, to and long-term evaluate In one we safety

that's the of the primary study. And endpoint so

any single-arm take In treatment other -- as can if and not continued efficacy these kinds be on interested course, at best and at we'll in a biomarkers, because addition, effect, you be of we'll markers. durable of study a also amyloid looking obviously, we had there's see we'll would answer whether gap we'll or effect in a look --

with [indiscernible] So, center portfolio. take the we question, TECFIDERA second fumarate Ronny, remains VUMERITY to to the But and your promotion. a concerning strengthen in part superior our of front overall opportunity with have the

see You performance. the

We a be of share to continue will the the key fumarate And road. to down increase again, support. metric

some access with and months is competition after we superior to from are to We what after pleased have months the for a launch. that few XX launch, date seen competitors,

We the with we So Forms [ph]. closely very access. the are Start and pleased monitor grads the

that see being far to Forms tech We issued more ex are is there pleased so than tech. Start

a It's We'll the but when early. more back still So it's we have this -- beginning. too more data. is bit with a come color

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

should IP us the is And what and week? what to Can case were next get go actually your morning. would an question. a secondarily, there, going on steps, for fall, in then process on Good actually taking there? case? the It's remind believe, us be we next the Can of the give are decision the is on you you I IP. the week. court IPR my Thanks to TECFIDERA the status the update the next IPR the what Thanks. timelines way appeal where

it's so Yeah, Jeff.

the a is from end IPR -- So of a decision, the no February. there expect of perspective, week than first the later

takes will that we the that's appeal, it appeal decisions. in process XX goes if it typically favor, plan great. So that be our If the three -- on the goes of and first how doesn't, to Depending to months. XX

to those two. other mid-year, if month minus go Two a plan the XX and that's expected point to out tends those, we again, period, plus those those Virginia our If and or way, Depending not, -- or on great. months. to to read take are some appeal cases, go go Delaware, how XX West appeal

of So We periods -- unsuccessful, if there's we people have are obviously of just believe risk. the appeal or Nonetheless, difficult patents. multiple valid be that. whether launch considerations decisions at to and we're weighed. handicapping to do about. await not a kind these that we we'll There's then There's need results obviously of There's number predict. we the outcomes talked

the to short difficult in it's predict term. So

developments apprised as people year. keep we'll our move through the the kind we way So of of

line question is next Raffat Evercore. with of Your go Umer the from Please ahead.

may. focus very I history approving I that for to Hi, it's long wanted my which the drugs, minute, CNS thanks have a if on in so Al, and/or of negative questions. And failed past. a for taking trials just has much clear Alzheimer's FDA

FDA time that results goes direction, across they every However, find single every pool down I thing. that

thought also, understand. were EMERGE is, how very we the how should be should like? So all arrived what I splits about about you the because to before the guys and pool before across arrived I'm does what analysis That And many understand be will Ib, we helpful be you that at post-hoc my p-value, done mostly trying if question Protocol that Version X Phase results population? at should ask to look ENGAGE, the think theoretically given PVX.

is So Sandrock. Umer, this Al

the of results haven't disclosed We kinds any pooling subsets. including of analyses, or other

would the that always I going this we're case So is when But would that look of the I say I not history in I -- it's do to back done. approved you assume not pooling mean, wouldn't that that say morning. drugs,

is -- that. to I exceptions there that are there think

not that would and here, so I see. And let's assume

post-hoc how -- post-hoc, question was but many did it say there We question the how many was Your I analyses? were. other don't remember

Your next America. question of Meacham with is Please Bank Geoff the of go ahead. from line

good a Hi, On just have on in morning, patients few. question. I clinical for development, Thanks back the SPINRAZA. ZOLGENSMA SMA, guys. to switched

the you real seen world. Just have this is guys in if occurring that curious evidence

And on bigger Al, then picture question Alzheimer's.

you therapy, markers look down other as look surrogate PET imaging fast road, such feel anchor like FDA you initially, the then combination at can cognition. at an is antibody approaches, derisk? In do at is A-beta that words, road and look down the assume I a sort we if of a path to So there -- when

wanted post-aducanumab. for Just Thanks. get to a sense looking at

Yeah.

they've getting that I ZOLGENSMA. still about as So we switch-back, and ZOLGENSMA, you the They're -- if because -- consider gene they're if your had on that it, will, will. of you don't SMA therapy. the first if question really was arguably effect

ways, a some of it's like in adding combination So SPINRAZA.

wonder about It that. you might are have heard the that. want why real to We -- And people happen you doing world. in does might

this in -- in happening it's because data. are -- we data. feel and of are the But starting physicians that But terms what that hear And have and more conclusions in in point. from at so I are we're -- world think parents real collect collect have since world. to room we we be starting improve, interested might And data because the real any real the we very it's from there to I that's that, world. don't like evidence, to we

pleasantly first or already were thing why with had In aducanumab combine something of was the terms built the we that pipeline affects we combination of an BANXXXX reasons did combination, we tau be ASO, a tau, tau. that We therapy. anti-tau surprised always envisioned would Alzheimer's the actually one to obvious or though. way And that aducanumab and affects the

need combine in So step, as stages we'll that that would the keep the be the next certain most nevertheless, to combination are disease tau have I of mind. there But stages. think do with then the obvious to more that to thing and than maybe other

of some employ effects potentially in A-beta And on further. terms look that reduce, the but the to will we track, tau, also kinds anticipate we effect yeah, a I combination other only that not fast clinical will decline in need we're and of biomarkers reducing toxic biomarkers, way. of proteins a trying at ultimately, more additive of show to But expedient

an important. the Alzheimer's be alone still able no in be not Unless do will you be you can impairment, that do cognitive words, think of is where may it there early where only may I in you're if biomarkers stage to other approach. it,

next Your Yee Jefferies. Michael the with is line Please question from go ahead. of

question. the for Thanks

preparation for actually of a comments you being some actions would sales payers more of aducanumab, and including little SG&A. they guess, type expect -- and from maybe the to around what drug And putting perspective are color how of made just hearing some terms I would this you type around comments work on? you're Could that type of when be You what what in had get. drug put they in timing of around, done the force

a also know on is for And reading this what sure for DIAN-TU comment that on this study read-throughs perspective one to is out. a or the it. to people amyloid will into I'm maybe make means there I then Al, a study. quick just just -- about beta your appreciate try anything

types from of -- which that started to of segments. referral diagnosis, origination the US, different I market, an different, get journey US, launch more dynamics within two if started and work with the the from market than the Michael, change different understanding understand readiness, actually, to within patient ago it's is the the So years with the the can even markets

has have community stepped and is our biomanufacturing be obviously. functional support team. important. ready okay, as leaders also We engagement This with the at increased the approved, is this with the the also level finalized needs budget, with to for first the affairs, and been in to up large the funded a demand go-to-market be and the And eventually for support, hiring scientific started, Engagement medical US. And has discussed.

stakeholders, even if today. you are no almost is progress. terms In with We drug can imagine, engage making cost it's still because as we of there early, price,

the customers, with leaders through So beyond and association, US. pharmacoeconomics, US patient we the and engage in all the mostly

we it's people which Beyond transition society. access about -- We condition full-blown of dependence, that more assistance wait, the the the that all more the costs affordability. to the the price, transition and so much and loss know will to

we'll further we basically, engaging, start invest So is hopefully, have order in and in in our belief. that all This the incentives to R&D. field

good and broadly So listen. ask step advice we but we engage and for step, progress, by we

Inherited Hi Michael, is Dominantly it's so Al. Alzheimer DIAN DIAN-TU the Network. --

because the the APP, So is obviously, ultimately disease most patients, either protein, in that amyloid causal that process dominantly mutations in lead are or [ph] to to likely be patients inherited Alzheimer's enzymes of it. precursor amyloid these

target that changes conclusions. and hypothesis. is results want think is very that that I are are are the engagement negative, to amyloid the tested. biological make are gantenerumab My in evidence interesting and solanizumab the before I If think that to further positive, lend I there And brain that results so support any studies. these If understanding I'd being of would the see

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

you in there, appetite do I opportunities? do allocation, and time? front my relative acquisition development at ask Thanks. guess, both market of you a dynamics, powder much have look and guys. meaningful the repurchases, between have this considering portfolio prevailing you -- enough morning, business continued dry X attractiveness do taking you to do to capital do Good way? how have and in bandwidth Thanks an the on And plus on given considering the for how share billion Great. at wanted you I Company's current and pipeline, the question.

for So the Jeff. Cory, question. Thanks it's

from position good a in we're that So perspective.

and We have cash in XXXX. the debt flow the net that strong as billion of end expect of again In XXXX, we'll year no flow generated of a $X have year. we we cash

both, financial got flexibility to and been we've both. So we do the doing have

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of that. well. the we to share the build billion continue feel But about pipeline. capability those we assets $X.X point, to good like have to as add So at We'd same and authorized repurchase

both. the do long So make we'll of shareholders and to continue best are we'll that the the good interest decisions have in to capacity term

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

that development? updated morning. good program. be a on for inhibitors your taking just that I Hey, initiated could And in or kinase Al, one from we since for Has any anti-LINGO Thanks just you the had in pipeline two see study Al ASO can views question. views why share Thanks. the that comment maybe on then MS. LRRKX there? differentiated changed you

believe, that say effective. would small central it's But the we on only for places. in these to to molecule, about instead it's a the system, we for ASO, thing disease. be LRRKX in will to I'll familial whereas only One affects ASO for Parkinson's sporadic small mutations, early the days nervous affect Parkinson's other and approach seen. is LRRKX give LRRKX, And CNS. enzyme also to not a remains that, whether even of say the patients of it the kind is or it's the reduce potentially inhibiting for with target, be LRRKX disease, of may going wonderful you -- a PD the than another drugs not molecule So due it it's but levels intrathecally, Because enzyme I with have other

And now the they study of in based Phase on different demyelination II in to actually we the we're patients first MTR study advanced II is DTI. terms be based doing had intact that sense actually based sure imaging from the on on Phase selected had anti-LINGO, and that that exons

interferon II first the promising, the it chose we're the with kinds only interferon, on based as study. when inflammatory disease the most that well as combining see first also to multiple the precursor to of have We or In Phase remyelination. you with TYSABRI perhaps TECFIDERA, oligodendrocyte with dose it less it brain cells able now may And immunomodulators. looked remyelinate trial, different but combining the not we we're in affects inflammation, the be of And combined better. whether level

the So second positive. And we'll the that's is out difference. whether find or soon not trial

go Your next of Olson with ahead. Jay line question is from Oppenheimer. the Please

for complementary is amyloid create a from on the question. you the in to Could patients positioning on positivity? And rationale fall studying below taking that segments successful a here elaborate thanks threshold patient whose congrats of BANXXXX BANXXXX for levels for in would Hi, XXXX, and be aducanumab? distinct goal the the

naturally that. and of we best, we franchise, view a the do -- need we'll drugs for Well, multi-drug drugs two where use will and data the they as do view we this part fit the

because mean positive based accumulation. visual Just amyloid doesn't that they're on read, there's no not a

between X, stages defined at studies, X two that's and document by study came year -- And last of distinction. Alzheimer's guidance think I FDA in the looks some various disease. -- looks AXXX the of both that on Stage the as the stages ways, both both Stage So out at the

studies important two both are study, So I and X those to evaluate that say X, believe. I both would Stage Stage and

more time probably There's questions. two for

from Your Evan Suisse. with question. Please come will Credit Seigerman line question next of go ahead your the with

and of questions would you they for on not the results from congrats quarter. Or to have share Hi, IPR. consider just mid-year? guys. the until kind I'm to next you potential priorities court repurchases? with looking the your versus you were Thank the the of you your development go wait see week my cases way, re-prioritizing If towards business would taking results

see March. week independent six being what So the happens we ago, what as thanks And for or business from months in next good opportunities development question. happened M&A

look We this from continue continue -- are at event. remain engaged opportunities, we be to shareholders, and value to create very BD for independent team the on opportunities to the will the and any

year flow. just ended reminder, Yeah, we net operating And generated XXXX, cash as billion a in and the $X we in with no debt.

both. capacity we've to So the do got

ahead Robyn come Karnauskas question. line your will of with the with SunTrust. question from final Please The go

Hi, the thanks question. for

give any be and Alzheimer's, can think we you of a the it Just good I but it that's margins some capacity, that [ph] still to you've give harmful? of that goods cost huge us comfort, know manufacturing as a investors too lot comfort have guys you and should antibody, approved, of amount antibodies. us about around wouldn't very be given

this? learn Thanks. extremely system? amount And that give So to can when you any would drug the the make us overburden we comfort this isn't it dollar high that would

Yeah.

question. thanks So for the

much say to And in a get we'll that specifics that it I'll of time, regard this will So to be well margin want a at produce, into fair been the we're that it that it's will nature do with -- I looking substance the for don't we've obviously point something given and too while. comfortable but economically. at

I'm closing So for going to comments. turn it to Michel back his over

very the for So Biogen you material the very attention. a We page your team thank now, and Thank is turned XXXX ready priority you obviously, and, with a for aducanumab. all potential a XXXX, call. for on being the a for at of strong

the call. Thank you. End

for Thank you again conference. joining today’s

now disconnect.+ may You