BIIB - Earnings call transcript Q3 2017

Due to licensing restrictions, you must log in to view earnings call transcripts.

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 2017 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 like conference now to turn to would over the Mr. I Vice President, Calistri, Investor Matt Relations.

your conference. begin may You

Matthew Calistri

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

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

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

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

Q&A also Paul McKenzie, Dr. and of will Pharmaceutical Chief for the and Dr. the Technology. be Sandrock, Al Medical portion EVP We joined call Officer, by our Operations of

services. investor to also earnings newswire releases I future call, conclude, I related starting via press and like intends events earnings would that, publishing Biogen QX releases, calls, with cease Before earnings note the to XXXX to

section a and when on will they become post statement Investors of website, Biogen's www.biogen.com, these issue We on materials Twitter available. the

@biogen. is handle Twitter Our

the call to Now, I will Michel. turn over

Michel Vounatsos

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

$X.X For prior $X.X in we GAAP income grew the enjoyed quarter billion and period. generated year grew record hemophilia, net earnings excluding XXXX, hemophilia period income revenues the billion. with revenues of the this $X.X same include non-GAAP On Revenues of X% XX% revenues when from of apples-to-apples quarter, billion. an a of basis, Biogen third ago. We net

GAAP the transformational areas. both at Our become believe becoming we neuroscience July, was was a by leader to we In EPS world's record to In needs. our efforts R&D our on in are of growth non-GAAP communicated address strategy what leader, pursuit most developing and four EPS unmet level. the therapies becoming core significant this are focusing we medical mostly $X.XX, $X.XX

us our are our while encouraging in new five business, our in sharing that execution are creating those [Spinal strategy This priorities. requires Atrophy], to progress performance priority and each with cash resilience All also we strategy. successfully We important turn. The Muscular first core making we of fortify accelerating core, on Today, of for are value. the implement simpler MS of we generating highlighted important developments business maximizing sources leaner create a is flow. and to meaning Overall, exciting model. our ensuring also significant SMA operating

the strategy final in leader of and With context, through priorities, prudent pipeline efforts development our building neuroscience, this am both returns. We that shareholder maximize committed business expanding high-impact collaborations. developing to R&D discuss to QX strategy performance. to two to and the are will out our form very believe have We and I pleased and work this be internal and putting efforts portfolio. in but capital are long-term We reprioritizing we our flow the we the ability cash our allocation neuroscience believe

to third our expectations. First, MS our business core up in the quarter, held

arrangements operating neuroscience have we and a number pipeline. U.S. and with progress the simpler meaningfully collaboration SPINRAZA, Neurimmune, globally. made momentum towards Eisai launch of We patients and continued our we as as leaner operations our made We strong our model. progress streamlining in on we treated evolve advancing the grown We and improved the

to XXXX eager build into are XXXX momentum on We this and as we beyond. and close progress

strategic MS our start core the maximizing first me of our priority, business. resilience with Let

Our the all-time Biogen driver significant performance $XX is MS of generation. be of for business had billion, to near MS midterm we in $X.X close revenues, expected royalties, OCREVUS source a to and including of million QX. cash and the were high

patient continued count increase franchise key to drive growth. in for add cash investment versus free This year core fueling a relatively to X% globally, with the a helped $X.X versus which this patients our We billion prior and future is QX. flow quarter, stable

improved formularies on also overall have We U.S. position our for XXXX.

this pleased with We are very progress.

demonstrating have a the portfolio And strategy. credit to our the recently list. payers. their have and placed five Aetna access embraced give an PLEGRIDY national major of just open in U.S. a trend on seen preferred of of trust AVONEX, We team building and plans to month, executed I have value TECFIDERA, on lot our really last that They

$XXX performance primarily TECFIDERA the versus in we the Now maintained a remains in a quarter overall therapy. decline same X% high year, a compared record prior saw the due demand. a revenues TECFIDERA global as MS X% QX, – market Global and patient the to patients in slight core increase X% share total period. strong the U.S. in our revenues products, its to to MS were billion $X.X increase TECFIDERA of therapy million declined quarter, MS over leading this third

revenues TECFIDERA TYSABRI year and relative due patients X% quarter has year grown XX% remains XX% decline global quarter grew to rapidly Japan, while TYSABRI the $XXX over million. in U.S. of by were the over build, million, year million impacts quarter, and share. were QX, from inventory approximately with year. X% over an market in high-efficacy an $XX As In approximately a $XX leading decline XXXX, QX. benefited therapy, MS prior $XXX QX to the TECFIDERA over XX% revenues flat TECFIDERA levels year-over-year to Europe, comparison. reminder, million which to In an TECFIDERA inventory for

TYSABRI discontinuation, versus patients, continues the launch it re-stratification JCV-positive by an In patients were grew the quarter, the seen benefited its as OCREVUS last management. U.S., label, as amongst Outside improved patient and on revenues $XXX have in providing updated clarity X% Europe, TYSABRI U.S. from particularly of uptick million. We in

our While here. we are has not resilience, shown of signs MS stopping some business

We we are bring to continuing model closer including accountability evolve our structure operating and of to will in rollout the regional MS, which new increase customer. us a the recent U.S., the in believe

our about would strategic like current see talk as We future Biogen. priority, I a and Next, to SPINRAZA for SMA. accelerating driver growth key second

in in generated U.S. the XX% in by including to delivered patients with in being the pleased global SPINRAZA, $XXX QX. launch third quarter, the million revenues U.S. the We in end increase very the million are compared saw on the of the $XXX growth of as of as We we number therapy a

as months Approximately build, As large completed of remained a regimen receive to loading QX. a maintenance revenues U.S. did reminder, SPINRAZA patients of four-dose in every third not flat inventory of the QX QX revenues in quarters inventory in maintenance while the dosing. who a once approximately four prior the number in due $XX in dose, attributed levels U.S. were to the dose million XX% included quarter

opportunity patients growing are also to in other on currently a XX suggesting therapy remains treated Additionally, of old, significant age in of Infrastructure and patient the XX% most are over Type patients are first, improve. that years population. Xs XX% U.S. the and over the serious Xs, and Type the continued

that administered the submitted over we of start of have As increase have sites now quarter, last have third XXX And over sites from XXX end the sites SPINRAZA, XXX forms. an quarter.

therapy, Importantly, great we from a received on patients indicator forms yet for demand. have of are hundreds not start that

diligently Outside the broader U.S. we and ex-U.S. not or reach start an the QX not thousands treatment. U.S., aware help what are of reach who SPINRAZA on help million revenues of have trying size we launch. yet working of launch $XX also quarter Revenues indicated this were either We the SMA of team. to in while U.S. are older these in population, QX. from are patients to intent SPINRAZA surpassed the volume patients start SPINRAZA our To saw expanding this to SMA

We Middle countries and America. as recorded in Japan, we named from patient XX in sales as European East have revenues from Latin multiple the across now launched well and countries

dossiers and we Europe. far, submitted pricing So in reimbursement XX have

and This filed we SPINRAZA Argentina. to aim was make we in time, Switzerland, and the this Over globe. in quarter, approved available across Brazil widely therapy

operational research and a total XXXX, number make expenditures of this, value-creation restructuring XXXX development in and up create priority million, to prioritized opportunities. resources, to initiatives. we achieve $XXX with by through a expect end strategic operating million model, reinvested to be streamline redirecting leaner the our and $XXX intend we in of and operations a of strategic To up primarily of to For simpler to organizational a to relocate across and our program goal commercial

biosimilar, and our the the anti-TNF to Moving for biosimilar Biogen the authorization revenues XX% approved our prescribed biologic business, European granted million, Commission with most adalimumab is the first IMRALDI. marketing treatments. Europe biosimilars company in to three now grew $XXX for

biosimilar business. greater strong healthy ability patients grow more the achievements an for believe in in our our we in to We our foundation saw and us in core So We value shareholders our this We it was future. several franchise. quarter, to exciting accelerated business. even with resilience with and MS continued progress country an gives SMA create launches,

building portfolio sources ensure our expand to optimizing pipeline better We And pipeline. new team. our The that pipeline for are to right existing R&D our candidates; now building including: working would that this is to position incredibly BD been senior and has new in underway capabilities; excited about our to partnerships win value. further as like as enhancing and we for and the transition of looking capabilities well create invest to actively management the work plan advancing in both to team growth; to assets; tirelessly develop I area, have to us our

leverages in few over we the a with it turn I Biogen Asian commercialize now in distinct option the to Mike, U.S. adalimumab. Eisai. to profits Europe and its Biogen's will and renegotiated XX% receive the our markets. profits also Europe, in agreement XX.X% of Eisai Eisai's Before in our develop profits partner, This of first, XX% and exercised presence of in the and strong U.S., highlights; jointly Japan. advantage

for Alzheimer's assets. We of demonstration Phase confidence X lead Eisai's pleased are our this by

of new to the adalimumab. economics agreed improve royalty decrease obligations Neurimmune. these also We believe We long-term our will both of agreements to

of announced the extension on Second, long-term aducanumab. data we new Phase Xb our ongoing study for

our and encouraged support they our of are are data these by studies. X Phase reported design results, ongoing the consistent as We with to previous

next will We data Mike analysis conference [Clinical CTAD on will Trials from Disease] and details Alzheimer's week, provide shortly. more this detailed present the at

Ionis completed trials for initiated Parkinson's fibrosis. We epilepsy and assets ASO in for and stroke our positive we our disease. pulmonary had advanced we readout in MS. for with in in natalizumab of enrollment in natalizumab tau a We idiopathic And opicinumab STX-XXX Third, multiple Alzheimer's pipeline. disease in collaboration in BIIBXXX for in

critical joined has has continued talents. Senior Medical. we management to President, we Therapeutic without is momentum. become build not Finally, our Senior which could Area. joined as joined senior as Alzheimer's President our Vice Villalobos Jariwala Medicinal to We this Senior Dr. maintaining the team, has world-class as leader Vice Biogen Science. new Vice in neuroscience of Lee Camille Sanjay President, Anabella Biotherapeutic believe Worldwide

will In over in make an in for the our an future. our progress on R&D. update call CFO I the for to Mike addition, to announcement progressing now are we in and new well a search recent near hope turn

Michael D. Ehlers, M.D., Ph.D.

highlighted on good leader neuroscience. and which be Michel, morning, Biogen's we you, additional clarity Last R&D vision the strategy, in Thank quarter, provided our everyone. to

area We that burden, as medicine much represents of no opportunity other continue economic neuroscience. need, as scientific global to patient believe and

are investing like highlighting update releasing at core comparative and time enacting on now unmet growth areas. spend and needs. emerging aimed several MS MS We in including for strategy we are R&D leadership would to effectiveness this investment of and the advancing at diagnosis ECTRIMS the XX for real-world some definitive to Starting to neuroimmunology, This have within disease as and oral ACTRIMS key we well our are neuroscience. initiatives made Biogen R&D seventh with in address through than TYSABRI, significant an quarter to improve we progress and data week, I as data and new the joint is an progression. TECFIDERA monitoring meeting, presentations more committed poster

measured directed sustained we opicinumab, first-in-class exhibiting treatment subset the LINGO-X. a at a identifies antibody durable treatment obtained will per lower years the whose clinical improvement with diagnosed presentation transfer a with XX in MRI myelin response One been those suggested patients with highlights greater had kilogram against At found brain monoclonal magnetization opicinumab upon the more and within content meeting in as in was lesions MS last XX-milligram be that who patient radial and blood integrity with which tissue Biogen the associated by for will in These of SYNERGY ratio, as of we trial, we diffusivity. relative clinically our X provide preserve, test of AFFINITY and dose, Phase tensor human analysis the hypothesis key plausible Xb imaging Phase data characteristics measured diffusion that a post-hoc trial. biologically a by believe the

from controlled therapy versus the potential characteristics The measure opicinumab a the anti-inflammatory randomized, AFFINITY, overall both multicenter, improvement primary placebo-controlled integrated XXX as opicinumab will the over relapsing SYNERGY pre-existing relapsing of time. through MS The that population. closely response of study and improve for an endpoint and evaluate on dose replicates to Specifically, adequately responder DMT XX-milligram that score, remyelination. Xb SYNERGY to with double-blind studied the their who A alone MS, to per in are patients worsening this the trial disability was with potential in Phase enroll earlier patients was exhibit patients of kilogram therapy initiated who dose aims an of disease-modifying designed is consistent year. fixed be study, add-on disability the

investigating X.X. and The observational antibody PML JC index antibody greater low the risk than natalizumab During through studies. virus less or to risk remains increases levels index estimates that equal the than values quarter, suggest data large Lancet and published between X.X index new correlation at PML JC virus at for

which the patients an PML lowest of value was treatment, cumulative X.X%, of with than to than index X.X. with years risk over Specifically, less patients at in of increased natalizumab X.X% X.X greater six for index

and the information provide individualized physicians Our are can benefit/risk hope label, are these patients when and currently we the is FDA. additional EU with in that data with reflected currently discussing these largely assessments data TYSABRI. making These data

months have within AD ongoing exciting as Michel also a include Alzheimer's MMSE clinical and of an In updated the one events extension the of and had PRIME, study most continued decrease level plaque the at referred considered long-term quantitative and cohort recently We We of new called of the the State levels detail we manner, suggest and the of Xb analysis during and plaque data placebo-controlled which and the dementia, to aducanumab period reaching of analyses aducanumab treated and on that amyloid in to. interim robust rate cut long-term headache, kilogram with months, disease to Examination] At Xb the in XX-milligram In point observed look per conducted months abnormalities, extension adverse in amyloid-related developments up months industry. scan. We on titration between up the the a remaining analyses fixed-dose to discriminates additional from we believe Trials the decline in in ARIA. of portfolios and The commonly months, the and cohort or dose for positive negative extension, a Phase were with time-dependent in the cohorts. Phase most the the plaque In up forward [Mini to long-term Boston. with a week reduction the Mental dose both to and Conference XX up fixed-dose these patients XX Disease sum-of-boxes CDR results Clinical amyloid the aducanumab in next XX reported below treated presenting data cohort, XX at Alzheimer's patients in fall, of benefit the cohorts. continued the in imaging titration consistent treatment treatment. patients fixed-dose XX time-dependent treated amyloid XX was to

antibodies. with clinical correlates Phase microtubule in X/Xa tau IONIS-MAPTRx to mild a hallmark Pathological XX% than Infant to study with with status. partner, reduce as ASO, Congress Hammersmith we in treated Examination. International associated antisense strongly of lowering differences disease infants patients. Key or significant Our data selectively of the or the or by Phase represents none data of accumulation XX milestone weeks, approach of of BIIBXXX observed protein a Significant the oligonucleotide, and lowering and in monoclonal month. Neurological were recently neuromuscular in unique that at of protein a Saint-Malo, Pharmaceuticals, include the Ionis from at Within baseline designed disease, France. to responders disorders, tau less tau Alzheimer's patients ENDEAR XXnd brain. anti-sense earlier the presented Society via this motor Alzheimer's initiated the the therapy levels World X relatively compared SPINRAZA patients new administered duration Reducing to the with is patient intrathecally Muscle for with highlights dosed first of untreated disease study an SPINRAZA responded independent measured tau in production BIIBXXX equal an feature as a to analysis collaboration is the

their age profile. growing disease. that XX with And the a For treated from SPINRAZA to than those of regardless of or untreated. and in in SPINRAZA at Examination SPINRAZA XX with of ENDEAR, presented the studies, of in patients interim to stage benefit larger EMBRACE There not double-blind also of were difference responded equal benefit/risk duration those weeks. favorable survival showed analysis The of compared of of responders demonstrates with a milestone demonstrated eligible body presented. statistically disease for and this responded In infants EMBRACE, significant meaningful SPINRAZA can Data none a Hammersmith lives less XX-month children make evidence children and Phase contribute to greater weeks a to ENDEAR the X treated with baseline, overall, in sham-procedure-controlled was a EMBRACE untreated participate disease cohort. the proportion multi-center duration XX% event-free Infant Neurological in a infants infants SMA also the infants was treated while motor study with data or than SPINRAZA in the randomized who patients

excited continue into potential Beyond be the program clinic gene in to about SMA, in mid-XXXX. therapy to we SPINRAZA, the advance of and we our expect

progress to in has X alpha-synuclein the of the Parkinson's anticipate on study targeting Moving this the from progression, sharing we Phase with disorders, antibody the of enrollment anti and in completed disease data goal cohort our pathology our BIIBXXX, slowing year. Parkinson's of trial, core movement next disease

asset the a are of by We this end initiate to of study Phase the also planning X year.

on Moving our pipeline committed areas core also just areas. and to not we updates, emerging growth to but other enhancing our in advancing are our growth

of neurology, data stroke up we Natalizumab next X acute stroke period. time potential infarcts, acute in Specifically, therapeutic complements with currently early a XX is with with post-stroke This conducting hemispheric and mild-to-moderate a fully Within acute ischemic with in the is trial see brain targeting in we functional our outcomes first-in-class we study BIIBXXX, significant targeting pain, expect hours start to stroke, neurology, enrolled, aim year. of improving severity, neuropsychiatry, natalizumab with brain large inflammation limiting year. the planned program ophthalmology. severe window by in ischemic glibenclamide and IV edema Phase are Xb acute patients Phase a next after onset. therapeutic The

be see U.S. therapy believe and target During patients we potential significant opportunity. X initiated XXX,XXX OPUS, we has for drug-resistant study for antiinflammatory over the a patients EUX the also alone, to natalizumab, With which Phase quarter, in we epilepsy. with a focal first-in-class the

and seizures which potential vascular assess efficacy, study phase. if alpha-X may study in adjunctive ultimately tolerability clinical the natalizumab are and of efficacy participants. integrity, reduces therapy and the help preclinical adult lines rationale the XX-patient of to a phase six-month help stabilize of as blocking double-blind research double-blind barrier determine interactions believe and the will leukocyte therapy. multiple of blood study to continue after severity placebo-controlled objective natalizumab The safety, Patients to a of open-label six-month Specifically, natalizumab integrin with reduce of to primary seizures. benefit, adjunctive for we Mechanistically, with be the providing frequency is the to frequency of expected completion reduce a into brain randomized may

study growth for neuralgia of enrolling, is radiculopathy our data a currently year, BIIBXXX growth expected of in to X program Also on X in of next biology lumbosacral we Phase idiopathic as well our IPF. or emerging Phase pulmonary trigeminal recently a pain, Xa area neuropathy. next Phase core a areas, we painful our of fibrosis, neuropathic Phase Outside for Moving small year. anticipate Xb with initiating and emerging proof in study STX-XXX as trial achieved BGXXXXX in fiber or

our development beta from IPF within trial to Phosphorylated results been For the assets with compelling baseline bronchial and intend from we with models. like alveolar of that value. alveolar XX% XX-patient as as of activity by remains demonstrated pathway phosphorylated to and long see BGXXXXX lavage isolated Xa as to science the levels we add up measured Phase BGXXXXX, that of the patients neuroscience TGF beta, correlated SMAD potential treated The in TGF by are inhibition IPF not mediates focus, fibrosis signaling have preclinical from increased macrophages substantial down-regulation the continue SMAD transcriptional multiple subjects. in

addition, TGF-beta to support with year. Through study, was genes study with safety a anticipated Xb identified efficacy into In of prespecified impact level to next dose we BGXXXXX this Phase and appropriate an a associated multiple advancement profile have signaling. shown

areas, build our to in neuroscience, invest core out key our strategic within augment growth machine pipeline. are in to reminder, prioritized and R&D assets in a emerging translational priorities As our our capabilities and and

drug facility the ASO We other the to into for promising XXXX, opened our which to market. end, success year R&D to increasing support pipeline. strategy R&D component and have candidates five North similar to emerging us to Carolina areas, of leverage core this manufacturing strong lab made get programs from nearly on a modalities. We In from development recently probability faster to focus an year. offer aim the in track the progress on key a To bringing greater in productivity productivity research our we growth to level transitioned we highlighting all the and and double of And through our for historical way oligonucleotides, ASO novel the antisense putting next our have growing is than or platform transitioning a clinic that clinic. within of

been leadership have productivity. We team, future maximize help Michel building discussed, also which our to R&D R&D

long-term in MS, is But While body portfolio, already including drug clinical in are to that of and high-quality reaching program promise. our data Michel. advancing addition, assets to number within and accelerating continue we enhancement. growth compelling make require we I clinic. in disease showing will important a recognize pass focused neuropathic remyelination; on progress see: expanding our look highlighting we a neuroscience In clinical coming in our will continued the growing opportunities advancing call the make summary, through portfolio; portfolio in external a and growing Parkinson's forward further back leadership highly disease, of we here industry-leading in now a productivity progress stroke; epilepsy, pain; the of IPF; Internal mechanisms Alzheimer's we to our the portfolio ALS; new SMA; an candidates biology in across unique portfolio, months. defining

Michel Vounatsos

Mike. you, Thank

with let Now XXXX. are share how we me of the rest you thinking about

expect SPINRAZA on uptake a terms in and trajectory in internationally. patient U.S. of continues the strong We that

dosing However, be mostly due in markets. driven anticipate QX revenue by ex-U.S. to scheduling, the impact we will of the growth SPINRAZA

our QX. And for expect We have a conclusion, we OpEx invest increase QX, as on believe will priorities. QX clear to in In we negative MS modest net behind strategic direction. expenses, MS expect our typical a OCREVUS we I the we seasonality portfolio, expect for have in impact and versus

shareholder imperatives, and we linked long to value do everything strategic aligned are term. our actions to over Our the is maximizing

business resilient. Our market-leading remains MS

a We arrangements especially our completing in in very neuroscience. our continued on portfolio and intend importantly, We business portfolio. an can advanced increased be leader neuroscience our expand neuroscience We our Neurimmune. Europe. assets we development more with we focus in to momentum, further And this SPINRAZA continue mission biosimilars to enhanced to the impressive We with revenues collaboration launch. that our so achieve Eisai

disease; BANXXXX the in Looking several radiculopathy; stroke; pipeline, readouts gene forward, within for therapy for we Alzheimer's painful ALS; lumbosacral neuroscience and in months, for across in natalizumab including: to XLRS. BIIBXXX BIIBXXX XX meaningful BIIBXXX our XX Parkinson's; expect program next our

would the without in a clinical caregivers, Before that, we for achievements call future the and employees development all and I could we The passion our are positive not to be thank our patients' and to impact Q&A, lives physicians, of dedicated making will programs. go around With realized into who participants open their questions. like commitment. world past the and on

Operator

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

Umer Raffat

Hi, guys. for a parts Thank you question. aducanumab patient to SPINRAZA taking for actually on focus so leave and the much stuff out that. I count of my Michel, rest I'll but, the call wanted for two to minute,

why First, than I $XXX the reduction implies. just reason market is ask $XXX payment And through payment is wanted what on to think very valuation the I different the this royalty valuation to on million aducanumab. Neurimmune based the the of what because the for million implies implied for aducanumab

I your a was this curious. going of have negotiation curious the much ask just right on aducanumab, I R&D Eisai context going is bit to to understand also How wanted of or onwards better. just in reflected make So was amount then and spend that's to aducanumab for in towards just of And expectations now? appropriately Street the I whether Thank your XXXX, is of spend payments not. XXXX starting you. And because R&D

Michel Vounatsos

for you thank the So good questions.

the be with potential pleased took so opportunity important in lot with alliance important. of We will and these and it's very a most we the is I reached agreement very And we probably this XXXX with this therefore, believe are the alignment so belief. new far, work, in in aducanumab, agreements. this act We think

on bullish right the that many the I assumptions, in collaboration we operating – and we the With that working long-range in our this working a are two the And have will achieved very in we this past, with product. have logical future. we together it's long-term there plan, things between agreement million, and long-term in with the we say play, are the $XXX the Neurimmune, For remain, opportunity and on present, companies.

link, potential terms I much of I it's of but would profitability if succeed. future that able in further to the go aducanumab very So for of we're positive not the the speculation overall think

outcome. the I a of So Eisai is and will beyond. are only Concerning as the spend to Does that this need time spend the with thing add to XXXX, we pleased large something, for in clinical starts somebody can clinical okay. tell meaningfully spend, contribute in portion overall XXXX the to occur want you the to

Operator

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

Geoffrey Meacham

in SPINRAZA I Michel, in it's QX, to also guys. Good and guys reimbursement, or is or just be on are for the more you're patients, saying one, this QX worst just want in the Obviously, discontinuations some U.S. severe context which get flattish wave Thank for wave would morning, the two Thanks you. for is you question. than patients? for seeing putting most U.S. the difficult difficulties that, getting the

Michel Vounatsos

question. the for Thanks

team. with patient XX% very having And not a I are We growth pleased in the momentum simple the is the achievement, compliment U.S. so

also XX% enlarged we and proportion, this fully in way that the the the in of or we actually administration we since on so order momentum patients is for patients XX. early As regimen, more complicated patients of between if mostly that to X, patients the the they dosing are everybody experience the the well, Type access got getting expected is said with anticipated, and beginning the becomes of it more the are have QX reflected more year, to other those the their a on can with the XX% of leaders, reach. of And I of so the because a normalize, the we it's proportion see. Meeting the and of know the spine so dosing as have impact the will in of Type basically patients, difficult they dose But in majority you'll above as that one program age and X. of because and are Type the time dose We has as the normalize yes, this have dynamic We and come recall investigating routes complicated, and prudent mostly X that's are potential maintenance procedure who regimen. with see we why Over the based revenue, out ones was model the of spine be, patients and been the prudent larger more the on to will complicated. the complex. fusion, expect QX XX% back mind, that complicated are we just this scientific fusion it patients those the

are scientific to leaders, lower, give of others according to proportion is apparently, fusion And The just the context. some easier. much ex-U.S.

SPINRAZA in we and on peak the So change. U.S. and of remain our did objective the potential ex-U.S., not sales optimistic

Operator

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

Eric Schmidt

those of a problem squaring end the just Thanks same with new you of circle increase receive the I multiple to sounds here and majority number patient QX I'm doses. – adds, for well large a very therapy did having like a from the variety in had end taking with SPINRAZA. of question. of patients patients guess to on It on QX, XX%

not can't many new with free patients guess I growth of that be is you to get but question gross-to-net sort. maybe change must or how ask the So or different something that being drug added way, same it There here? a Michel, that to some

Michel Vounatsos

free there dose. was a growth increase XX% of impact. the with I XX%. patient major is the a it's the of forms of yet that start Again, not were patients it dosed hundreds make who a mistake, the are of little we clear This a was It for unless dosing bit we why onset The correct, XX% complicated with that This drug, regimen very later more initial dynamic for patients, not to that patient patients maintenance That's slight is yet more was have not time growth dosed, disease takes are so is and get those. see. that the and but that dosed.

another again, is dynamic the is So adjusting. this that and new. not infrastructure I But said, is the as system

Eric Schmidt

growth QX? expect you Do in

Michel Vounatsos

the last saw element QX and I an we QX. Thanks, inventory will that on and was between play not yet Eric. QX, comment

Operator

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

Ying Huang

the BANXXXX question. is your good net expectation XXXX high products? the other talked products. MS for talk Hi, a you And morning. Thanks level maybe Maybe, for formulary also access then pricing Michel, and what coming we another question for Can on end, TECFIDERA for you the taking is about my program XX-month the aducanumab, know an the Eisai analysis with they for Thank results Eisai the on clarity is to that in? just opting did from have opted in and of any follow-up before you.

Michel Vounatsos

almost is are And is progress pleased as is which leadership for will the prior typical gross-to-net market now access can on to and the with communicated, imagine. and the we years you get contract. position for the impact And under very as for arrangements the U.S. I our started So similar contracting helping, that XXXX,

in actually. very enhance. one didn't to we a We or dramatic order see erosion limited a maintain So saw

pleased we Aetna. with So with momentum, open including major and some including payers formularies the are win like the

So is this achievement. an important

Alfred W. Sandrock, Jr., M.D., Ph.D.

Sandrock. Ying, this is Al

talked follow-up saw seen what which so that follow-up next the terms XX-month trial the same XX-month the cohorts. of be the of presenting Eisai we've all far, the is week, from data about In in the and in saw, include Phase Mike they things titration which fixed-dose Xb cohorts that we'll

Operator

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

Cory W. Kasimov

anything Hey, you've relative in of the guys, to question. good that thank by to one. keep is for strength over there guess taking Thanks. overseas? it surprised you and early different Are U.S. I the you SPINRAZA there these noticeably my relative launch morning, I'll days? seen

Michel Vounatsos

for question. Thanks the

ex-U.S. disease. driven top the U.S. line anticipate previously, And revenue see we for We did terms a prevalence that by in are pleased. MS, as mostly and see communicated unlike proportion SPINRAZA, We higher of very of the that, we opportunities of

on helping patients element is waiting one the and pleased We And the mostly couple Germany, than named in that program. XXX overall, few maybe to Turkey, XXX that was access in are very strong. in and we the got Nordics commercial in shifted launch were we reimbursement already program a ex-U.S., order early Europe, in since East, of this was Germany patients number countries, just driven of going large the identified early or that gain weeks. to to to with be access journal the recall by more America. you'll goods. Italy, countries, – official early patient had Middle Japan is a close and also some the sales But Germany in So Latin momentum very

unlocking trend trends country just the countries – obviously is, that a at different anticipating now, that not many same So ex-U.S.? we basically that the question in the in believe be not basis not based anticipated growth as reimbursement, We linear sequence same are and the of opposed you have as U.S. of this time that on same will access, the is opportunities the on

again, internal thought trending the I be our in trend direction. very we above we right think that And overall, nice momentum, are and smoother were this it's will a targets. what

Alfred W. Sandrock, Jr., M.D., Ph.D.

Europe. approved, in Cory, a put interest early XX we it, had patients when in compares we had some access timing data program the the countries Europe. so was between in in XX lot the a to XXX in on across more probably to to than numbers more U.S., That just the patients EAP and little drug the due about saw we when

Operator

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

Geoffrey C. Porges

if talk your just the the I for Michel, Thank on in Al, Alzheimer's, you and clarification about talk you terms access intrathecal frequency And very for Al, much, there a Michel, that has double then, for years, policy significant and this to deliver category could single-digit the then should increases I be able could, overall going being we ASO been you've of Thanks. one-time policy could treatment? to forward? taken this you. changed about question. on and on and the the for you question, the MS a dosing a modeling quick year, the pricing? prior price Is Of apologize a then basis driver year. course, what company And in pricing the

Michael D. Ehlers, M.D., Ph.D.

I'll at first the Mike. take stab a is this one. Geoff,

I access of all. studies the subjects. that turns program SPINRAZA anticipate don't out think It we this initial terms in at in significant for any really dose-ranging intrathecal problems program with was Alzheimer's the findings more safety delivery that it about this. they're than And intrathecal are in

what dose we're we've significant then SPINRAZA. challenge than And to trying get idea seen see range. exactly or standpoint, So we with more the a anticipate any from an right technical don't of

Michel Vounatsos

cliff. last policy. comment exactly. before. much market performance look the ever And And I So XX.X% where OCREVUS, pleased very continue and volume, at And know the is to when concerning holding Biogen the was question, actually we Biogen, can. is with second a we a that over it It not the we and of MS will flow the that important The the meeting to price cash at so will the start me in we two That few quarters as where for days to it's last OCREVUS activity organized We contribution, let so are in share. intend an terms best launch portfolio. XX%. of is our we expected, saying are this recommit on resilience generation, speak we don't we'll a so momentum. leaders, drive two going if a the the as to I including demand continue as and not was minimum with quarters, we erode still defend share generate that all can by

Operator

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

Carter Gould

on congrats all updates. your guys, the morning, and Good results

to more Neurimmune, with end back aducanumab, companies? or we about come should Were opportunistic after proactive and how to Just moves these? from your these moves overtures the Eisai on think updates on those

Michel Vounatsos

the who's potentially opportunity playing best to a where. what agenda gets this the it's the that are for I for the or product, These a core the have Biogen, at opportunity promotion So the to thought with also Eisai is are intend the how that is We the therefore out the increase relatively we at But and best see opportunity we deals, two of give the move. achieving. the important. the pleased more and think back. win-win, I partner an co-promote day obviously, not the operation CTAD, data the will details we Phase to I we chance to hear would coming with see it which few I X/Xb, this And have signed contracts and the years in MS were first are We'll portfolio, be and operation could and and improve data. the

I would So these we with say, pleased are arenas. upgraded, very two

Operator

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

Matthew K. Harrison

just to go too more because much. to piece we morning. I'm just time. I'd for square? you Great, what one starting us Thanks good And for the beat don't figure SPINRAZA sorry numbers to out missing. be back Can to question. help this like the taking trying just may I'm

in maintenance XX% inventory the you beginning, sequential a from thought growth out the back that had you had patients. at patients but had second of revenue you you dose. XX% said growth, I new if quarter, the So XX% And

like I and but almost doubled little had So of on new a dose. patients – hundreds you some substantial patients – add maintenance mean less, you it seems taking

like seems it patient by per So the come XX%. price has down

what are missing that we right, numbers? else is in or those So

Matthew Calistri

Hey, Matthew, this Matt. is

me to try help Let clarify.

say growth, the end XX% third we're when is of end of patient we first, the at at to So looking second what quarter. quarter

quarter on versus patients the of the the at you XX% at end the number If therapy we of patients. second third end look quarter, the more of at had

unclear. how two, many the third three one, the quarter end received or of Now doses patients at of is those

that. revealed haven't We

a probably other on patients was So thing more part square that math. difficult XX% it's revenues the the little for been came we And the of who about to reason talked you of had that's plays doses it a there's bit And doses lot the so know a the loading quarters, prior in that's little dose I complicated, nature how math but maintenance dynamics loading of of versus out. a here. from makes

think gross-to-net of I impacting. don't So it's a function

believe XX% of over time. normalizes said, on we And just expect that saw, free. as of timing of we is you doses. As a something the are it's function we patients this more It's

outside U.S. is the there's come of said don't about majority QX. I think said think the to growth I of solve that expected We the the all trying commentary the U.S. to you're other is for growth the thing in no message we is

would outside the that majority would in the there growth I message be is come from but the the of growth of U.S., think U.S.

that rest So trying in SPINRAZA that help? I We're just in seeing not to think send U.S. to it message dynamics the world. in Does the growth you're don't the of the we're comparing a

Matthew K. Harrison

what's we us just think guideposts ex-U.S. trajectory. it countries? it maybe existing Yes, should or additional Is does. country I you And could to I give you've on commented new I going consider patients trajectory. some launches ex-U.S. grow in – guess But on think

Matthew Calistri

make launches that would country one be. assume we of there launches new can new will believe drivers could – country You be the

some countries. of As that just comments diversity of at That's countries a have the the made see you up across we've of the you look sales. made, already the and world more going majority you're rest approved the Germany at Turkey traction as other and look our we're belief. to But making,

Michel Vounatsos

But countries But like the can product we launches first Germany still momentum, has both. expect Italy, obviously new you a long way phase, actually in to the go, add in new momentum. should add so speak, while will

Operator

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

Terence Flynn

Mike. taking good for Hi, question, maybe Michel morning or for one the thanks

to on externally. later thinking of maybe looking the business deal you're cadence about and development us early stage, business referred thoughts give You or how latest deals. maybe Neuro stage, both your Thanks. development the focus, just

Michel Vounatsos

Mike more can get will and add I So color. started,

when after have XXXX, we we TEC pay to [TECFIDERA]. mostly first, that cash flow So generation, less we royalties and cash this strong on have will grow expect flow

on to the sure allocation the we dollar towards of the the we as share the secure that, elements. on opportunistic did make to may efforts will the repurchase shareholders building of the manner will price we repurchase, now, terms And share So communicated other continue in where that the of shares And also and share allocation based capital an will we unlike neuroscience and maximization the in prioritize, have shareholder the this for return. of do in capital majority to the past back pipeline. we addition,

we'll and those opportunities. there And Mike? the And the we we the very a of of So looking Eisai beyond or be early of are companies. at go the valuation and time. of at Biogen if remains lot stage early took opportunities, careful assets Neurimmune different spot are sweet stage.

Michael D. Ehlers, M.D., Ph.D.

within important two able productivity assets one was the that. just to bit add our little a increasing I'd add and to R&D couple the to committed a was be Yes, things of We're number new of existing quite to portfolio. to pipeline, pipeline. Number

got We're committed sweet more Michel beyond. entire a to advance we're in of well. mentioned more is external – derisk number innovation clinical spot, and sweet oriented. of we But believe, through organization be augmenting beyond So quite ongoing. of portfolio and and of We've lot retuning and R&D course, growth. really we're to to a evaluation, early-phase online externally bringing proof-of-concept search the that We've capabilities. look because our active those and spot those been our ability discussions really we within our assets

see assets an that productivity existing both think into will time coming a portfolio. I the over number So and portfolio of increase the of you in the

Operator

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

Aharon Gal

give cost Will in an me (XX:XX) therapy leapfrog and some hundreds about difficult opportunity the that therapy as is question treat Have morning hear to been guess stable? gene how it Good is just us triple population to you could, platform. of opposed of the mid-XXXX. suggests able terms be fitting cost? to on for in and able think Is both to patient. in, the you'll in the entire SMA. manufacturing about the be If to transactions here. there something away you dollars to Good capacity starting be trials to just that. around your my thanks you be an able a Type now get from your per Cost more here to thousands I address per X question Folks move would structure? landmarks enough talking to of material you patient

Paul McKenzie

this that A you from for gene Ronny, for thanks gave. recent in great seminar Sure, and question the therapy Thanks that industry. the people of is Paul really benefited McKenzie. lot your

beliefs great and our question up manufacturing our development and around bring around capability. You ability a

platform with I to on that you have will industry-leading. drive We therapy allow to As gene our development shared us before down that's doubled believe capability. we that a

clinical We allow dosing. half development very the strides make supplies our our on XXXX around manufacturing second excellence, also do great and have PCL the our for invested and we activities, progress to of development We're continue for partnerships that process. excited And these platforms to in around manufacturing future in both parallel. commercial us

So to well portfolio as more a but continue believe agenda therapy in the months, real play. we the to to across come platform we're upcoming positioned drive our in gene

Michael D. Ehlers, M.D., Ph.D.

is Mike. this Ronny,

following our of are a to Just mind clinical in SPINRAZA. And of play approach platform an still with on, has and Within is have our that front with SMA in we attractive center all particular, is which SMA there Paul's safety, number how could beyond. think in there's advantage And along a certainly right to competitive one area things focused of opportunity we patient be up patient think with potential are with is a at, subtypes of are believe We experience. are looking for quite SPINRAZA combinations administration, I where and in that a gained important be timing SMA of with delivery lot real on the manufacturing and subtypes. for things that that dosing certainly which we're going experience course, ties that within I that out. lot route this comments,

strategy. So safety those elements therapy are key between manufacturing, patient sub-type, our of profile, gene delivery route,

Operator

go of final question with comes the your ahead. And line Jefferies. Michael Please Yee on

Michael J. Yee

thanks Hey, question. for the

given you aducanumab's X Eisai standpoint the Given just data to in interpret how us Phase that from update high on with the coming, advancement the BANXXXX can and hurdle opt-in, remind a of the how hurdle there now opted Thanks. just would so this the there's in? be would X two fact that program given about high you they've far ahead, programs whether think for or a Phase that

Alfred W. Sandrock, Jr., M.D., Ph.D.

Al. Mike, this is

of in how hurdles actually BANXXXX? to what is rest CDR which the or the with trend want BANXXXX. would the need hurdles finally, And then isn't, a all, thing I events, the rates so that. we the a to with to First are look the it's there what least on plaque composite as decision. like there contract aducanumab first which as the there's reduction, I is the are. way the course, interpret data effect favorable at But make to adverse If then prespecified of the efficacy see, agreement be, I effect The key there If includes ARIA. and sum-of-boxes, allow us things see. then of reduction that Is at data. And said, I look don't want there plaque that, know is we measure, we'll prespecifies with safety, of such next of compare to the the then what a at would

Michel Vounatsos

all you bye So day, a great thank have and now. for

Operator

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

Biogen (BIIB) 24 Oct 172017 Q3 Earnings call transcript