BIIB - Earnings call transcript Q2 2020

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Operator

Good morning. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2020 Financial Results and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers remarks there will be a question-and-answer session. you. Thank Instructions] [Operator like the now Mr. over to would conference turn to I Mara, Relations. President, Joe Investor Vice

begin conference. may You your

Joe Mara

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

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

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

over Now, I turn to Michel. call the will

Michel Vounatsos

strong quarter. patients, and we And strong us. have to morning advance With serve financial thank another everyone. a execution, joining priorities for strategic delivered our on Good continued you focus

with begin me some developments. Let important

team the proud patients meaningfully an X. disease. therapy This completion approval development EMERGE, data PRIME to with ever I incredibly the market the data our of from clinical and positive have Ib with am from tireless Biogen’s cause we Phase Phase opportunity to devastating their FDA the Biogen III reduce of change program, work of dedication leading bring potentially and for for and Together for submission completed First, to the clinical the comprehensive our collaboration space. positive the first decline to Alzheimer’s of and this and ongoing first US from followed study aducanumab, for submission III the submission July results in supporting the study. on ENGAGE unprecedented includes study including regulatory a Phase

aducanumab to patients’ some for decline result reduce of that show and daily activities data time. help help living, certain ability to both which perform of longer may period in the Our cognitive for a independence function of may patients

if days next and we communicate has both response of the us been terms these from the decisions accepted, steps, we submission review, within plan have been notifying FDA whether from a In granted priority receiving the submission press of release. a anticipate if XX we date, accepted via to

increasing aducanumab leaders We in with impact readiness, assess have how launch thought engagement our and experts potentially practice. clinical including our to could progressed medical US better

as of of collaboration together the with meaningfully Japan, launch the to are to Europe. remain our bringing efforts readiness had ramp and cross-functional payers for Alzheimer’s are have disease In aim fight new formal consultation market This to we established indications, and across aducanumab and progress the with of tau of long both is prepare made Biogen we the term. gene we to with proposition, potential progress aducanumab’s engaging US. EU and now We our positioned the with study the focus a to regulatory Eisai, broad over collaborating therapy and quarter. we to to significant We believe the continued beginning our initial the Eisai, we with programs And to BANXXXX progress PMDA. in and in that Multiple to regulation optimistic up era neurological including aducanumab build modalities. of targets interaction have on are franchise started III, collaboration marks multiple defining disease, the filing We for We this preclinical we Outside on and includes course as with believe Overall, disease. change US, in for Alzheimer’s our and we submit including we Alzheimer’s team readiness partner launch Phase which to about lead readiness, have formal a operational. an currently beginning preparation make in preparing the an informal a had Alzheimer’s. we market in regulators the Alzheimer’s value disease. targeting new and treatment develop short is Sangamo site with range first dedicated uniquely meetings therapies the which prospect a

decision patent court regarding West TECFIDERA. disappointed our in Second, are we Virginia for the recent in

decision the in intend for Biogen to positioned well opportunities appealing will are the creation evolution final Biogen in core Difficulty] our for this space. capitalize what of still IP. defend and positioned value We shareholder we growth and to No on as [Technical vigorously our business we believe time is to matter outcome uniquely now the lead the is and be, work

Phase beyond III important with filed ALS, seven opportunities and readouts ophthalmology, deep XXXX, data stage of creation as in seven lupus mid-to-late value end Alzheimer’s a areas, or including in disease stroke. XX assets, the pipeline have and by such of other clinical near-term We

Third, to establishing deliver and creating to including for we as contributions company, strong Jeff processes finance many August. operations yesterday, cost and as disciplined culture. the to very strengthening team, our will management like quarter-over-quarter, results helping Jeff a be down consistent stepping his a announced CFO in thank I’d

strategic Jeff ago, period X% We Compared quarter in our period priorities. endeavor. same year against are We $X.X to transition. to revenues staying pleased well be will brief our a grew future on billion. wish review performance him QX that and a second progress now for ensure the to his seamless I will a

earnings GAAP EPS share $XX.XX. XX% non-GAAP to quarter $X.XX to Second grew XX% and per grew

COVID-XX impact in in from Importantly, following saw quarter. June earlier we improved an the momentum

MS the MS as Europe. revenues, QX the and portfolio our to saw quarter versus billion. The US market patients products new MS We market for year were performance X% this business had for VUMERITY focused royalties, $X.X demonstrate product number in resilience. the quarter on our increased share a combined. and on share prescriptions First, of share fumarate TECFIDERA in continued with strong OCREVUS and prior globally our strong of increased stabilized maximizing potential we our including Overall,

note in with the US MS it’s lower by COVID-XX, launch significantly Although market we has well that the were impacted disappointed have been new in switches patient VUMERITY, which to both of as and the performance physicians, engagement the to for VUMERITY. as reduced due important impacted starts

represent in Importantly, clearly GI patients. may we is believe of tolerability VUMERITY that the and differentiated terms better alternative market better MS for is increasingly many treatment a aware

increasing allocation next-generation Going forward, maximize our strategic fumarate. focus this we is our now and resource on to are VUMERITY,

approaches in is Canada have new which help hopeful this year. that second and will and of recovery critical medical we management strategy the submitted in Switzerland the new the quarter, remyelination. the potential in we could year. continue pleased represent were this for to this are the to the year, in VUMERITY’s investing the very of help EU and of MS half combined of approaches with look remaining approach readout the by market file Outside through and regulatory filing transformative needs. plan improve of end our part lifecycle reversing VUMERITY We in US, of be disability unmet in this will slowing A We address to even to trajectory potentially dynamic the portion innovative to progression forward or opicinumab the

Across will the to a of believe our lifecycle and high we bolster forward. MS for US approval BIIBXXX, recently continue opicinumab, priority. overall for products, oral advance to on and subcutaneous an offer our and inhibitor important current therapy profile, with formulation our addition space. broad EU portfolio MS these going filed we a to high Difficulty] competitive potentially is BIIBXXX treatments In [Technical dosing and BTK best-in-class remyelination efficacy of We both profile in management a focus assets

We of the potential continue dosing interval TYSABRI. extended for use to advance

offerings. advancing of the improve its label pregnancy. And to tolerability of regardless updates an during use outcome potentially we to and TECFIDERA we formulation broad both profile, are the we future interferon leveraging regarding have PLEGRIDY the the on of We and are maximizing litigation, of product MS. focused We with intramuscular present remain committed are opportunities

$XXX generated SPINRAZA revenues quarter increase versus second SPINRAZA. of prior year. a million, the global Second, X%

are being year. began access of June. clinical in this mid-April delays with We performance XX% an Including and SPINRAZA, of normalize in which the light are expanded COVID-XX, prior XX,XXX to due peaked trials, over patients to pleased versus program and May and in dosing the increase treated with

safety SPINRAZA a data which SPINRAZA administered market. recently deliver meaningful This can infants benefit on to potential there for We SMA this to demonstrating virtual the to groups. can presented ages is the announced new for scientific portion independent pre-symptomatic this patients. NURTURE Data all continues high real-world follows the gene benefits We SPINRAZA earlier publication unprecedented the SPINRAZA efficacy clinically at adults, sustained data Cure survival to all demonstrate meaningful of be meeting, only of evaluate study, SPINRAZA. the the of when important in an plans believe to across the to SPINRAZA treated need for rationale and and following efficacy a study quarter, year, compelling evaluating provide largest benefit clinically of a from and and This of represent clinical teens SMA the with with approved initiate the we new therapy. strong continue therapy benefits patients the patients population. added age our showing SMA

Phase Further, of We therapy in could study. to of through on seen SPINRAZA DEVOTE setting real-world for management higher lifecycle our greater study are the with in demand whether investigating the efficacy we going this XX% in the in dose result even receive of SPINRAZA. patients I long-term SMA, also of SPINRAZA have extension in gene

long-term we impact €X.X generated savings $XXX an second the for expect is work particularly Third, biosimilars million sustainability healthcare the This revenues in in increase the as COVID-XX, quarter. XXXX, the to and our to systems European observed in of We from approximately contribute continue quarter biosimilars to systems. estimate XXXX. for we will important the early headroom which of healthcare to were create financial that innovation we as billion

a a We as movement into new disorders. we recently and US. beyond Phase We SODX-ALS EYLEA Bioepis initiated generated Fourth, in allocate cash Phase Samsung tofersen geographies, additional continue our cutaneous BIIBXXX New In Alzheimer’s remains disease, published III optionality biosimilar progress potential and our pipeline. erythematosus Medicine. for were positive Phase expand with lupus I/II for presented strong Fifth, from to in in Japan data for provide the us operations. addition, initiated positive study study we approximately capital. including flow the to and work of referencing QX, to to I In continue ophthalmology we flexibility our Journal billion in and cash $X in flow generation the results significant England and first-in-class

marketable external opportunities. business development We financial us have cash in the billion sheet, continue on and flexibility and balance M&A providing with evaluate securities to $X.X the to

something recent As approach past, in to short our BLA our aducanumab a innovative we well are thoughtful In term. have has all for maximizing both in we execute investment towards continued demonstrated the committed aim on the to the that summary, long as Biogen US. to strategy, patients, shareholders returns our submission the we for and bring to including the therapies over demands

we deep the continue well we leveraging as interconnectivity build believe potential are a to portfolio, the our risk neuroscience TECFIDERA, we we are of pipeline. mindful positioned While of to multi-franchise

need progress have end lupus value as I We continued R&D. to on for as ALS, innovation a year meaningful stage and well including our over of in ophthalmology, the readouts and SMA. expect will and in in for beyond important more MS areas recent seven Al unmet turn call update mid-to-late high now medical stroke, creation detailed several we opportunities by Alzheimer’s, of next

Alfred Sandrock

I everyone. continue they advance as thanking would team these hard Thank times. to work the start you, by for challenging their Michel. R&D programs like morning And good Biogen during our to

our by track only delayed on our Although of next uncertainty that having the expected majority seven on trials I’m of remains impact is currently with pleased mid-to-late end some on the slightly COVID-XX stage readouts or year. the that clinical are studies,

pipeline our now me disease. Let made second Starting with advances the quarter. to turn across we in Alzheimer’s the

therapy study have for we completed decline this a participated from study. although submission meeting FDA. ENGAGE, We Ib first mentioned, Michel in aducanumab to from and is not data submission Phase pre-BLA FDA. a to did meet study III results BLA the As endpoint; supporting positive disease; Alzheimer’s upon based positive Phase EMERGE, with the clinical its This for PRIME in primary reduce the the the

reiterated based this continuing agency BLA the regulators We achieving world. of our forward COVID-XX PRIME submitting in and review and EMERGE, to a to During for important the from the look the the which, reasonable. I with was working want crisis. engagement their milestone team midst around the that on other with data FDA congratulate ENGAGE during

and of continue clinical Alzheimer’s intermediate of also pathology as ongoing Together, to individuals a Trials this in reason XXX Consortium that aducanumab III disease. very of disease can We study the of partner a their of decline disease. and results The even evaluate end, patient cognitive These levels initiation we BANXXXX our delaying goal elevated brain. us optimistic in believe the the amyloid Phase preclinical Phase earlier reduce disease. progression similarities BANXXXX to Alzheimer’s with into for collaboration Alzheimer’s and the Alzheimer’s regarding individuals BANXXXX includes tau suppress the well are early or Clinical have strategy II the amyloid between area. develop as BANXXXX in administration of perhaps and the BANXXXX to in well stages of conjunction whether study, preventing expanding study disease. of with studies this and in early evaluate the or the AHEAD for Part Alzheimer’s announced sustained with will broader in positioned give portfolio clinical be the Eisai, early onset leadership disease even To AXX of AX populations

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we in also gosuranemab, to a addition antibody BIIBXXX, In I. have anti-tau Phase distinct

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a may we best-in-class molecule small make in believe have a that BTK highly inhibition it selective BTK I. BIIBXXX’s and of Additionally, non-covalent We potent molecule. BIIBXXX, Phase inhibitor

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We are that the patients updated New trial clinical US the of This pleased Medicine report this mutations in from ALS, Phase In additional to the and gathered SODX England to due data across include NURTURE label of results tofersen to the endpoints. efficacy recently biomarker multiple was showed month. Journal study. study promising the in I/II the with ALS in of genetic were in published signs of nusinersen

have are results late to forward assets study, We We ALS program these as Phase look for to is year. encouraged to cause well the tofersen ataxin-X. mutations which and results BIIBXXX as of out positive the most the other ongoing implications VALOR common targeting results next the CXorf, III that believe read by expected of for our the including and our disease, ALS, for due genetic

CLE detect individuals manifestations. the a measure active a resulted or on at in well-defined score, targeting like lupus cutaneous making erythematosus the turn progress BIIBXXX, outcome disease the and the evaluating and systemic study, LILAC activity. would II in BIIBXXX a lupus. to our encouraging humanized we without treatment Phase skin reliable in College results to from to safety we monoclonal European CLASI-A Rheumatology fully meeting, response or of I Last with Next, dose are antibody BDCAX efficacy of month, presented CLE with

program in week be with In We BIIBXXX to has scientists collaboration first with at and statistically Phase program score were the of plan therapies. III first anti-BDCAX of Biogen EULAR XXXX. with QX Phase development, we for patients in systemic both year. June treated III start by in active year despite our with at dapirolizumab, potential program the was meaningful the than trial; build versus next half in in the participants and presented Phase reductions Phase This the X.XXX. developed III clinical we of well with BIIBXXX a study BIIBXXX which, the CLE for lupus. results lupus, of antibody of on care interim results treated to to the XX treatment promising dapirolizumab with in options. partner in lupus to better patients significant showed of erythematosus from primary initiate this endpoint CLASI-A treatment IIb for being which franchise a a UCB, pegol late-stage p-value BIIBXXX standard potentially Together Specifically, less positioned and placebo a are by discovered need aim of in disease follows

for continue ophthalmology, gene Turning our X-linked retinal for for to we choroideremia retinitis disorders, diseases advance BIIBXXX treatments. pigmentosa, and including approved no with to therapy BIIBXXX both inherited programs

BIIBXXX the of data the III first from expect Phase in We next study half of year.

readout this product represents aducanumab. after our next Importantly, potential our next pivotal commercial and

in II/III We also of expect of half XXXX. Phase data study the from first the BIIBXXX

be ophthalmology, of and retinitis Parkinson’s disease, now pipeline deep year, the number autosomal across breaking on a infirmary will will develop end with pigmentosa. most entered to gene, dominant a including need pass multi-franchise ALS, have readouts as and growth unmet Massachusetts imaging, next at sustained progress capitalizing company. licensing have of mutations a potential this Through expected focused believe disease. a the long-term help blood-based are of diverse the to into the summary, causes we We neuroscience in work common which in and pleased MS, a space in among CSF degeneration Alzheimer’s we to we PRPFXX are agreement set on to the including In significant stroke I to our that inherited the aimed broad due create and science, We retinal to biomarkers source a for and drive treatment the Jeff. for therapeutic of Eye a stage Ear of advancements call important significant the mid-to-late portfolio. areas, innovation to pipeline continue

Jeffrey Capello

everyone. morning, Thanks, Al. Good

had the despite review financial financial to the the remain We year-over-year challenges position quarter are long continued will continue the in over financial now to strong quarter billion. capacity to we that business I Biogen our in X% execute quarter with for an as pleased We grew strong update the guidance. performance grow to full-year and our revenues a $X.X term. and provide another Total to second well. significant very COVID-XX cash

$XXX MS which, quarter, the our the As delivering in to quarter a attributed second versus reminder, Global revenues MS decreased X% was second the included to $X.X pandemic, without in of year accelerated $XX royalties. benefit OCREVUS million well revenues X% million this due revenues year. XXXX of approximately declining QX in approximately including billion we COVID-XX executed second the Overall, million, of believe of the OCREVUS year. of versus utilized business, the royalties prior that a we sales believe quarter $XXX prior in the we

Importantly, flat year. and decline US growth COVID-XX We prior of versus foreign see exchange our based International despite quarter the million. year, environment, of competition interferon believe new products million, a OCREVUS, are competition. the versus were part MS on negative were the the excluding very the in well the due revenues, US, from in versus effect $XX were approximately prior MS recent of MS increase our the share approximately the guidelines TYSABRI of XX% positioned to Federation. prescriptions MS revenues Outside encouraged treatment a we to in in within rates $XXX current

MS quarter of first of million utilized the approximately approximately second US the sales to revenues the we included $XX XXXX was we the benefit which, COVID-XX accelerated in attributed believe addition, quarter. million In $XX pandemic, to a outside that believe due

growth fumarate very second X% leading quarter the prior patient revenues impacted of approximately prior fumarate grew outside increase the well versus therapies US, $XX XXXX, a Importantly, continued decrease the fumarate year, $XX received. in as last of of the were revenue million TECFIDERA our revenue increased in second quarter versus revenues, million including strong in the approximately both by VUMERITY, to of compared US. year. US, and be X% drove quarter second growth in driven channel we the the In Global year. inventory an US X% to by MS

Second quarter VUMERITY million, and the majority revenue and have we of reimbursement $X lives now was access for commercial vast covered.

we Within the see with of prescriptions strong share execution to growth in pleased our US, the for fumarates were both prior new quarter. and total the versus

it’s product X% As our mentioned, by increasing making that for new including with are and the we to XXXX launches in resource is COVID-XX VUMERITY. allocation more declined overall Michel quarter new US, second TECFIDERA challenging, VUMERITY the offset revenues we utilized for prescription COVID-XX US, Outside growth important of note through impacting a accelerated believe that demand approximately the QX sales XXXX. $XX approximately We to the and attributed rates. unfavorable revenues was price million pandemic, outside by XXXX million in which, benefit exchange believe TECFIDERA foreign US QX included volumes $XX of

prior injectable year. by AVONEX the shift Importantly, including US, to the in the versus of PLEGRIDY, due across and QX oral approximately global approximately and year, the combined. or from growth In grew XX% patient high-efficacy interferon revenues, both versus growth by therapies. to America the continued XX% interferon XX% patient XXXX, decreased revenues Asia platforms X% driven decreased QX outside Europe prior TECFIDERA Latin approximately double-digit number and versus Pacific US patients

the given some total in we the revenues TYSABRI interferons began. see were revenues to interest outside accelerated share in quarter; million due that the sales this pleased million quarter We worldwide the second prescriptions quarter revenues US, the of quarter However, growth by second sites. In have first interferon and believe estimate pandemic. approximately benefit in share of infusion we something utilized year. of dynamics Outside is to new decreased see interferon of in year, increased the impacted second of we X% the and XX% Of at by time US, prescriptions inventory the versus decreased approximately versus year. seen a XXXX. to prior as the have X% was COVID-XX revenues $XX since the the by TYSABRI impact believe attributed not the the dosing included in we pandemic we XXXX equally of COVID-XX which, continued in COVID-XX $XX versus decreased which to delays stable prior US

we as and foreign the exchange adjusted year, share by roughly unfavorable million XX% volumes quarter. Within revenues due to approximately were the as prior pleased decreased new Outside US, by the to prescriptions negatively TYSABRI see US, versus stable channel impacted of the well $XX versus prior rates dynamics.

COVID-XX In believe of addition, benefit the second of due we approximately XXXX. which, TYSABRI in sales a believe pandemic, US attributed the $X the accelerated that included QX utilized to outside revenues million XXXX we $X quarter to approximately million was

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believe the compared starts. quarter impact The US, XXXX now the second year and as year the versus In quarter COVID-XX to Global versus X% number move decreased and the XXXX. me of versus second decreased X% patient quarter new $XXX on slightly patients X% SPINRAZA. versus prior we the on on prior by therapy US quarter to million. SPINRAZA the increased decreased to the XX% increased revenues first prior had revenues in an as Let

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recently-published SPINRAZA’s markets. patients challenges older the broader that encouraged to in European for in adults are of the performance in with Overall, real-world we helped data us of use the second we certain quarter the secure despite on Importantly, SPINRAZA COVID-XX. has pleased independent were reimbursement

growth And now over with many for we our there opportunities expect well-established of are evidence and XX,XXX. efficacy with of estimate significant We real-world coupled given the XX,XXX the untreated our Importantly, in a of markets. patients number patients established continued emerging higher product previous across SPINRAZA of than to this strength commercialize significantly we for global SMA estimate markets. see that and

year. move new grew we due revenues and million $X XXX,XXX market COVID-XX. remains as patients Enbrel related first now the utilized have X%, decreased now being with were XX% decreased versus increased we across our benefit our other Despite the biosimilar attributed the quarter business within second the by well markets. quarter within other grew revenues with are previously-anticipated revenues volumes to our FLIXABI of prescribed grow to in impacted one of $XX from a Total Total year-over-year and impacted prior quarter-over-quarter approximately the Europe, the this transaction me, generated We in Number prior erosion QX continued corporate in We and the a was XXXX. BENEPALI IMRALDI slowdown which included in versus property OCREVUS QX COVID-XX XXX%, EUX biosimilars that $XXX result comparisons. partially the XXXX. anti-CDXX revenues. Europe. as in COVID-XX by patients due additional primarily and a relatively decreasing biosimilars estimate revenues partners, dynamics impacting believe $XXX versus assets. as by volumes offset onto XX% both by increased due to our XX% prior million to excuse the to by a me manufacturing the our revenues XXXX quarter Let contract the million in using also to of biosimilars approximately from COVID-XX intellectual pandemic, approximately revenues biosimilars believe COVID-XX, certain year sales major the negatively potentially immunology to year, due US prior which approximately manufacturing-related both higher of there to continue which, year, to accelerated opportunity biosimilars. for license was versus royalties this biosimilar one impacted Note, in business, due in million geographies RITUXAN quarter, to dynamics the quarter, of second treatment

effective other margin XX% our expense gains other Sangamo. still R&D and Let fair our to million on an Pharmaceuticals was increase QX our change approximately an $XXX year $XXX included for second income related of tax ramp revenue in equity a the XX% manufacturing QX We a expense our tax QX million to me income expense to expect GAAP million, versus was approximately profile XXXX. investments, XX% quarter of Ionis non-GAAP margins. $XXX year, XX% XX%, XXXX to a year, revenue. contract non-GAAP expense second on and were to unrealized is higher and valuation which our $XX margin aducanumab. was second Therapeutics. income current gross from of due non-recurring prior this to both GAAP benefit a In a in prior due increase in rate with GAAP million. in the of $XX and GAAP half year SG&A versus million, of QX non-GAAP revenue. improved This allowance. QX was gross up the collaboration improvement In now revenue recorded the we Sangamo quarter. net XX% an investments the GAAP by turn non-GAAP and of commercial SG&A and driven in XX%, in of R&D tax prior the year of the as we quarter, value principally increase was expense preparations tax QX in was related both

the increase was value XXXX, approximately effective for quarter of XX% of tax XX%, For $X.X the of our million $XXX approximately in our non-GAAP change X an second the average benefit quarter at prior-year the shares tax total primarily second XXXX, the approximately non-recurring quarter repurchased second to from approximately of We in due of rate an in profile. a price billion.

As the XX% increase our of XX% of the per $X.X prior $X.XX, to quarter, XXXX, earnings of the quarter. diluted second approximately the share. $XX.XX, debt. in and of ended authorized billion year. booked in us approximately GAAP the We per and quarter, cash versus the share repurchase brings and EPS securities the in cash end $X.X an December share billion flows prior a We second from the versus was In with we generated billion $X in operations billion which quarter under remaining year of marketable now second in $X.XX program net earnings non-GAAP increase

to for turn guidance potential this revenues be many to updated now me R&D of that for the from to TECFIDERA, impact total to $XX.X guidance intellectual year. operational does of our updated not billion. Let expect impacting property to XXXX. GAAP the our in assumption generic expense mind, Due potentially full-year revenues. we include anticipate situation With factors billion XX% approximately $XX.X XX% entry We approximately any

does non-GAAP and of our XX%. We to approximately GAAP $XX. our be per to of expect XXXX very to be this diluted share XX.X% earnings rate any anticipate XX.X% expense business impact or We tax guidance share $XX per non-GAAP GAAP SG&A development GAAP anticipate between potential non-GAAP be earnings large results to note to important It’s approximately to approximately that hard and acquisitions transactions are both $XX not and rate to XX% XX.X% XX.X% revenues. be and We to full-year to from predict. total as tax to diluted $XX include

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

shareholder truly I’m working back Biogen. over a the moving long-term Michel CFO entire of a contribute team of to believe like I conclude, is the opportunities as have I value to and comments. I’ll to the stronger his ahead say it. able forward. wish have to turn been Before I enjoyed Biogen I would closing creation of that call for for multiple luck in Biogen with best now position proud of I I what

Michel Vounatsos

Biogen long strategy reduce step aducanumab made want therapy the you approval in to financial decline continued to a our Thank for much, demonstrate importantly clinical so as to building strong Jeff. again results, to and of progress our first over returns our that demonstrated well returns maximizing the have requires superior we strive to we for we allocate continue appropriately, structure bringing make. term. innovative and investments now capital the shareholders to reiterate one delivered a strong and potential multi-franchise Alzheimer’s I execution efficiently, effectively the as This in patients closer this therapies to have solid past portfolio will quarter. always capital We to aim and from advancing as disease. as commitment for an we optimal

Finally, as crisis. our still by and events highlighted seriously recent health injustice racial COVID-XX that organization exists takes the the very inequity it the considerable

Biogen thing of to we our and we working our and contribute This to all accelerating Now taking pioneer purpose betterment from organization way vulnerable includes ensure doing across in more of like focused to I would approach I hiring the the our questions. societal includes term This organization patients, being focused a the and sustainable leader we open dedicated are positions believe Biogen for a address neuroscience our times. making leading us long science call I needs employees, in also who stands are well position this which the that humanity. to conduct Again, therapies. an our the than sustainable on community; in shareholder advancing to the value. environment to right during ever, as aim have access believe broader diversity proud trials for inclusion we that, already on to this of as the including tremendous most the on and to the positive efforts organization clinical the therapies over to remain long-term was patients’ the we With around thank challenging impact the a to lives, for our employees space. am access what be world will as for ensuring these we

Joe Mara

As you analysts we yourself are reminder, a there on question to one limit number call. a you. appreciate as would Thank can of the if

Operator

question come will JPMorgan. the with from Instructions] Our [Operator line first Kasimov of Cory

Cory Kasimov

taking for Thanks question. guys. morning, Good the great. Hey,

Let working me great Jeff at you say it's been with Biogen.

has initially of recently announced lack more III pre-symptomatic the move guess something that So study. rationale or you the elaborate about - choosing over Can Alzheimer required my the lot. of to what made the study? aducanumab? into it dose it Phase else? Thanks BANXXXX I titrations how attractive question toward that a is on Is

Alfred Sandrock

of Cory, is your third Al actually this Sandrock. every I question. heard word

in imaging sure, prefer trials. Phase or then forms and to So X similar think amyloid very BANXXXX a on would aducanumab. yes, decline both BANXXXX you in aggregated III II effect Phase robust true, also I Phase antibodies. I'm that, and to not of and and perhaps to in They Alzheimer's were but they and say comparisons both asking show are aducanumab disease about PET that's bind clinical both reduction a-beta preclinical have If I shown

clinical all partners diseases sure Clinical the that for with to Eisai I this very we're Disease we are your not that I that. is approach study Consortium. starting our seeing out and at Trials answered the - question I look have believe earlier so turns excited initiating We results these forward for hope of but Alzheimer's I it neurological heard it. - the best I'm

Michel Vounatsos

So for while focused filing we on with the aducanumab. BANXXXX we did support study the preclinical

for readout we we management patients back the during move a opportunities FDA the have on how entire the from forward. revert We once continuum on of and answer will disease lifecycle

Operator

the next Our from Meacham with America. Geoff line of of question comes Bank

Geoff Meacham

been to working with Hey, say question. Jeff guys. great want it's Thanks also the you. for

with is developments at next beginning you. share of at can over that much conference ENGAGE just year. you of nine wondering step that or Thank look anything - you us next analysis when a medical done any whether EMERGE, Another decision past the - one months on into I versus six since this could the decision FDA. with pretty of six could have in you detail But the the that go know the aducanumab. the months be you terms what to been is the guys published have past a over, say, from FDA, the if or

Alfred Sandrock

Geoff, of your the asking next gist months? get few you more over timing So sure are question, just make the we the to about

Geoff Meacham

filing. just no, analysis No, the quality the data analysis the for aducanumab details the the of and of support in of

Alfred Sandrock

of very MMSE, Boxes. we that with again analysis were dose, shows EMERGE, also published - clinical there studies; the portions of on effect. sure and question, on of the then study of first was - did on CDR-Sum three these even the that EMERGE a as highest well not was PRIME, do data heard We an endpoints. not I'm that support show pre-specified from secondary the doses ENGAGE, that believe on only is effect based an ENGAGE show is not filing similar I I that but effect, ENGAGE, endpoint portions all look But the which endpoints it the an did primary Well, much to though PRIME. the exploratory and negative EMERGE, from Geoff. the as your think and data And endpoints study, lower

all with ENGAGE consistent data And from are consistent the you and EMERGE, that. our So to get to the I really need findings with dose. higher think

Geoff Meacham

Okay. Al. Thanks,

Operator

comes question of next from Umer the Evercore. Raffat with line Our

Umer Raffat

on I market working TYSABRI, question. VUMERITY months lifecycle PLEGRIDY VUMERITY. management program laggard my on up this? just capturing taking for been important a and every the a precedent why guess why what focus share management on on is your and I single on lifecycle second. happened has complete Thanks for Michel, you hear management the commercial that you're like is would is, programs TECFIDERA, love I and question XX% may to a has well on guys. but been perspective take been XX%. Hi, my but feel almost I above lifecycle that's most And mentioned few for on if two for to

Michel Vounatsos

and we platforms the opportunities starts to switches. we and disappointment COVID VUMERITY the date life patent performance that forms Yeah, can launch start the I on We and for are the we long the on for question. based did management VUMERITY the December run. in this new had share impacted anticipate then you lifecycle thank encouraging patients' And and came, significantly on and have, that for you the working

not you the did will when it we will there remember December down strategy, a because asked you that months not in we question, road, And So performance of the the launched the fumarates anticipate was few be strategy times fumarate switch COVID. at three of that date But the and time, to organization a the the strategy results not lack all is an for over to excuse share US it. VUMERITY, not of enhance which this the are bad. is was for

meet brand, those the month stable organization behavior is So it's said next that doesn't and with this prescriber. that, mean XX%. significantly VUMERITY change very access, benefit all what it because it VUMERITY, Fumarate shutdown, of in now cannot a is fumarate TECFIDERA you next-generation increased good This the Having patients challenging on know It We there is on differentiated shows the as from you terms allocation. is GI tolerability. data. is could speak. it should who that challenging VUMERITY, on but difficult, of pivoting enhanced and to is one are we stay close the focus when When the new a on a it's the a to is good is your significantly TECFIDERA, focus launch. generation should have fumarate good time entire to the the resource because

should So, give you and we don't not. up,

Operator

line of the SVB from with comes Leerink. Marc question next Goodman Our

Marc Goodman

of if Jeff, was the change before. There the million like SG&A second Yes, wondering $XXX spend less talk than it's commitment you in has been ramp-up guidance. the It adu for could about I it looks in no good the your in was half morning. year.

So, from? Thanks. the cuts where coming are

Jeffrey Capello

Marc. Thanks,

much going spend. in meetings So, we've pandemic, less found discretionary there's on, less much other conferences, travel obviously, that and this -

we due significant will year. the half so, the savings that of in and back have And we guidance in second that fact anticipate that the savings quarter, vast is those of the the difference majority to in continue

Operator

Jay with Olson next question the from line Our of comes Oppenheimer.

Jay Olson

Hi. the enrolling fashion, BLA you. modules review? FDA can submission initiating you Since on a aducanumab began Thanks if modular the submitted question. waited completed the those review was comment of taking or Thank in whether until BLA the entire their they before for you

Alfred Sandrock

FDA's that don't submit want comment modules internal I Well, submit. processes. It's to did we available became to true on they as

That's on you so, processes it. them? And modules I But some I or FDA can't internal whether and had they months know. comment reviewed they've some now. not don't, for

Jay Olson

Thank you.

Operator

with the Jefferies. from comes question next Michael of Yee Your line

Michael Yee

with a voucher? Thanks, or review be on and were Maybe, Hey, Europe, Al, about how simple file. you just morning. the and you a you're on the about you would nice progress, you not And any not can whether used is Those priority question good then particularly, made it or unprecedented. and how Al, filing. think comment reason to comment there about not a guys preparing whether there logically congrats

sort and So, a similar is on that there of Just actually, you you've had much. discussion a comment with them, agreement? you've so Thank Europe. gotten

Operator

mute. be may you on Speakers,

Joe Mara

I'm mute. on not

Operator

the next our Goldman question of come will And Sachs. from line Flynn with Terence

Terence Flynn

half for more if And are Maybe the more I a what wondering, you question. of question a grow the to was then the drove taking comment assuming just on for can And the Al. maybe the revenue wondering specifically? SPINRAZA Thanks you anything to was me. year? Jeff, is change I two-part back guidance, going broadly, Great. in for

was CRO If you. the to filing involved discussions and I'm for were ADU the Thank party FDA? you in can process they III confirm the wondering that Phase the the if was with how the IQVIA trials? company just

Alfred Sandrock

answer Sandrock. it. going Al repeat to I'm sure Michael is not so I'm this previously, Hi, my heard

one On we hear it on at voucher. it, priority acceptance FDA to expect the priority the leave of the nusinersen we'll whether use haven't got review But approved. we're received we review a not and about the question, going so commented we us at when do have of to We going we're have filing, do the time to use we We or how it. notifies that. when

your regulators, was terms that of I question. the In of second the think ex-US part

process we also regulators, the of the preparing the Japanese European and interactions informal in preparing engaged a had filing for submission. have the that we and with with And we're as formally filing We have were well. EMA,

Jeffrey Capello

before, So, it I'd in guidance the we maybe moving way the things the see point the to pandemic where of first that the how in played light was on even to Terence's and left drove what out. you COVID we of with difference kind guidance. wanted back to view question quarter

we as what we sense from better described, impact of the quarter, was in still end and first some at quarter here Now, businesses was plus unwind which sit SPINRAZA both some of headwinds like we've the the got on a July, TYSABRI. second the it of the the activity and

We the some those to half expect into headwinds of back continue the year. of

was majority we see of significant SME COVID business, in continued difficult the guidance the when where April So, point US the month a would through which at the very did June. and of of guidance. May vast then kind out is a to months we difference strengthening due particularly strengthening also impact, significant quarter, predict you challenging saw look we in I strengthening to the was a business But and the did in of second if then that

it still went we're with wide another of So, range would because how comment fairly a be, back. we kind quickly assessing comes

SPINRAZA, So, which strengthening impact but with difference full encouraging. was post guidance did the for COVID in big year see we a down, is the

I helped how the conduct have we'll the on see was that IQVIA there of plays to III CRO was So, aducanumab. IQVIA. all think Yes, out. that trials question us of And a to Phase then

that were the they regulatory had interactions However, FDA. the not of with involved in any we've

Operator

Our with Stanley. of next the Matthew come from Harrison question line will Morgan

Matthew Harrison

you to will into secondly, as adu. Thanks. to you file question. you're move from What whether could what result comment around sounds it Great. that that clarify Good need willing morning. view Al, or then Thanks on to just use you not the just like review made priority voucher. can to taking not It III? say a study or positive comment just you on And Phase for One do for the you you anti-LINGO? see

Alfred Sandrock

Matthew. Yes. Hi,

the And terms on So, prior we're arm. is in a not X-hole looks and four we're walking, used X-hole comment which in the willing right, to of not is Test Priority we've arm not - non-dominant the overall - at - endpoint components it's anti-LINGO, response our primary of Voucher. in whether Peg in EDSS looking a core, or score, the which Peg and dominant terms Test

times So, area whether we're MS you and affects and of as four components. system nervous improvement in parts at central patients Because overall you the improve. worsening can And looking in or at one have know, another. not different

not, or we overall, the whether So, improved. wanted patients to know

addition to of course, myelination. going In to imaging be we're related looking to that, at measures

myelination So, for MTR, example, Magnetization of and looking Transfer is good that. be we'll a at measure Ratio,

in So, consistent addition clinical, be the see we'll with myelination. we to to measurements are that if have looking biological

Operator

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

Ronny Gal

and question. nice you Good morning, results everybody. the thank taking on Congratulations for

share you number the it the was with to aducanumab if You differences drive of organization? just used and the us that focus submission going certain have us or more patients that, was advance the you of the versus VUMERITY you the is using share is I And adoption who it a you've can total if extent if And idea you wondering the to in rebate is educational the the wondering there high presented and the what received anything can discussed placebo? instead, all even with done doses I of of of patients. with difference primary set copay review, various before those can you're of forward answer for patient cut FDA. same the

Alfred Sandrock

I'll first part. Ronny, take So, the

data PRIME. look ENGAGE at analysis and show found in what from the all evidence that the have negative similar who terms period of highest EMERGE, submitted over received And those EMERGE. I do that we that's a do we purview. efficacy chooses study, sustained that say studies is, FDA the of in we mentioned, time ENGAGE, their what three those to - will we So, show dose the I of to that

and coming CTAD And that's we and to supportive are evidence so, we data ENGAGE. why that's the ADPD presented from believe there

Michel Vounatsos

the on affairs concerning second patient at the salesforce since level. including of at you VUMERITY So, levels not the the can the fumarate, at behavior, is services their all the -- part on VUMERITY, - that at the aligned, level, are to schemes tell shape incentive focus payer I question on the medical level level, now

organization is on aligned the focused absolutely So, and of all levers. those

Next critical. five months will be

Ronny Gal

Thank you.

Operator

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

Phil Nadeau

whether as let move for pre-BLA the my Jeff, for the that the add well-wishes you to on In next is opportunity. in on feedback what you FDA the I'm in on three meeting prepared pre-BLA your Question the receive be taking Good that my morning. noted Thanks did remarks, question. the any an Advisory provide did more you, Committee were of likely? would the curious detail aducanumab submission based and you particular reasonable. help me for suggested meeting, topics Thanks. whether Thanks Al. studies over what maybe FDA the you years. the can indicate discussed,

Alfred Sandrock

content to the so, our of it's policy talk about interactions. Yes, not our regulatory Hi.

I any said in I'm further prepared - remarks. not what to not go I'm than So, prepared my

the Advisory of Committee, be at modifying of Advisory be disease In for the not reviewed Committee. terms would to an therapy it unusual this first type

So, for when starting or will time we that one at have the and whether And to it up the notified one. around we to be, accepted. expect Whether files the or are has we prepare been be to not we not FDA. of hear will that

Phil Nadeau

Great, you. thank

Operator

the comes with Tim Research. Anderson from question Wolfe Your next line of

Tim Anderson

been and question few data the of The terms FDA's feedback biomarker of amount has tau measured in Thank are you ENGAGE I of those collected remember, are EMBARK a tau what if over I'm risen context really capturing years. you. as potentially in which on on biomarker wanting the understanding has wondering a is the in this trials. biomarker, Tau you data? of you prominence was study, in on low EMERGE new that more CSF. quite And tau as to These size you in aducanumab. have or the My Alzheimer's few tests, everyone. last

includes that I tau think imaging.

the would to I What talk about willing test for heard FDA you've asked you helpful. arguably guys we is priority Thank disclose be is review. you. you have. a designation, data therapy views any haven't And for on been commentary So, you've breakthrough litmus how that have then, requested which whether better

Alfred Sandrock

important So, because that's Alzheimer's Tim, look with so. in And you're perhaps right progression, tau that biomarker accumulation correlates tau has best if risen disease. an prominence do you target at and in as drug to what clinical seems

downstream - beta we and to and already for for - triggered in imaging patients there be However, specific the for new sense factors, possible tau that of an tau, effects we a our And consistent that with patients amyloid belief which does. and patients PET - could first And both number and that a lumbar data to is by our that is be tau a many by interaction and by could tau. beta could we when on we're puncture trauma the is would ligand, were it's reason amyloid tau be spreading be misfolding But and use one. it it's twice CSF. is it's also imaging And introducing beta triggered amyloid. lowered, undergo we not that see imaging why amyloid that hard with all, and that, between - also or of convince aducanumab, our

not lot to But effect we convincing in is but two your show do by do a the two question. PET ask scans, PET forgotten different now part the data we tau, having have a for only CSF also scans of to imaging. patients. adequate So, to second I've think of types on And

Tim Anderson

Breakthrough.

Alfred Sandrock

with the that fast very Oh! June, and we've-- engage the last we appreciate we we a engagement say status., with do interactions I'll priority well, the about of where we've Breakthrough. And expect And we we've track much since have of to collaborative opportunity status with had Yes, track level had, have review. number FDA. fast FDA. to hear essentially constructive, a

Operator

question RBC Abrahams Your Brian next comes with of Markets. from line Capital the

Brian Abrahams

gene you What expect evolution there would study on any my of And question. Hi, taking reimbursement Question then, from for bar sort entry combo strategy and combination there. a looking had SMA oral? on much for SPINRAZA or additional guys a Is so and Thanks. for that of use? perspective dynamics. be with new the any commercial therapy? comment potential might Thanks out can you prep one of an in

Alfred Sandrock

are for I'll there's or study this Brian. clinicians it, doing for reason already doing study the from no not mainly Well, the A, is on The but it's helpful whether data patients. the to doing first because, reason part, take -

the of of for a data In consensus that on SMA. published Journal statement real lack fact, European and of a we're you Zolgensma called doing or question see you happy point on with key so, therapy And to is, Pediatric just therapy use the European it, in this they when the what experts Neurology and do there's improvement combination to out studies they And beyond of SPINRAZA you SPINRAZA. to more just Zolgensma add alone be see one one.

gain it's maintain motor better, motor so, you And really more more milestones. milestone, at looking whether you and them a whether

it's efficacy. really about So, mostly

Michel Vounatsos

use speculation to And I or on a claims. think based on good to and very help clinicians that it's research option not therapeutic based prioritize which

in you at to was we the competitive risk terms still there well product. they the is is Pediatric to the ease. profile leaders, a to therapy, we gene safety potential I speak pretty to objectives. the with starts consistent, consensus that for of underwhelming to And published be profile link I see behavior, refer to if When think wait. And there the landscape, Neurology, in European older FIREFISH efficacy was the position the their a hard need long-term If the And labor plans, of have look SUNFISH scientific no speculate the population uncertainty infant wait for the the characterized. Journal I back for and latest still for is achieving of yet. it's realty because

scientifically basically at all encourage the at options. So, those the looking

XX The approved product we of and and SPINRAZA larger efficacy behind a of is in we stand evidence. countries. body all in Biogen, have safety the groups, For age now

which continue in patients. believe this very really the bit is there be treatment is context, for a treatment in So, will SPINRAZA and market, good that to we this alternative good where a more

not but gene increasing last therapy. So, least, can we others the efficacy study I'm not there And the are working that. by after do to is response enhance sure dose. the

order in So, best educate I think the good it's market. to

confident. So, are we

Brian Abrahams

Thanks, Thanks, Al. Michel.

Joe Mara

two more time have for We questions.

Operator

Your next of question will Suisse. line the Credit come from Evan Seigerman with

Evan Seigerman

Hi, for my you congrats the progress. on taking all. and much Thank question very

release night Jeff's his expertise was you as the appointment, larger Mike's strategic in major this creating financial So, that leadership emphasized acquisition? under Nightstar evolution read was last we one in development from transformative was more it Should only to an there clear business press or the which considerations. out deal, as really value

Michel Vounatsos

deals. XX we space And we Jeff, where delivered inequity together the specialized. have remember, in are an we believe with Well, we on

spot most 'XX, This the market is value. to see stage. aducanumab. I maturing big the So, which early add readouts one will the beyond, extremely in now and start And that and is very sweet where the well 'XX, And hope, am coming XXXX, delighted XX is is portfolio to impact between this can important there we in with months XXXX.

that So, same invest very we you we BD long-term I in will aducanumab can the value continue tell while to active time, shareholder we creation. always But And the of M&A are interest potentially. approach we the the on be careful very at front.

Evan Seigerman

Great, thank you.

Operator

with will question Humphrey. of Robyn Robinson line the final Our Karnauskas from SunTrust come

Robyn Karnauskas

thanks, segue. for Evan, the question, for Thanks Great. my taking and

ask STAR to want III trial I So, about the for Phase choroideremia.

Walk first. reimbursement steps what coming are many it people best-case you. up, is, then And bar able data got to what us as to the and drug? You've Thank they with get the for the younger patients would to then, be be be scenario would what disease next young? treat the the secure when very-very you'll the best be through even

Alfred Sandrock

That's is, out, of which is XXX you patients our letter FDA This of standard. the greater Robyn. It's choroideremia, bar, is Al. increase XX is point Phase from visual for who Hi, the trial, placebo. in the the corrected and therapy BIIBXXX, acuity. proportion the trial endpoint the X two-arm Yes, best a the primary patients have about baseline so as than gene a

treated acuity of XXXX. XXXX. patients we in patient We our the last of the non-treated announced so, just better And to was November trial need December patients. in versus in This in improvement visual have initiated

And X on which expect we to an improvement study and X is And trial, had in the Phase year. on a natural encouraging endpoint. relative trial it the corrected a and some to out single-arm the results show compared heels do visual was the the drug history study first in a Phase so, next read of who quarter proportion best of very acuity that patients did of

same please. endpoint some hit basically closing and So, standard you. the just to III over by for we're trying just FDA. set Michel, it Thank comments, Phase using I'd to like for to hand the the

Michel Vounatsos

all about Thank thank our Biogen, again his you to in I attending. company. so and Jeff much, thank contributions for At for Joe, neuroscience. many it's pioneering to want you

we are XX of of phase years very So, our plus approaching a exciting development.

Our all many maturing. in the capital and is of pipeline space allocation that

coming We have very important readouts in XX months. the

III and your new Phase FDA all allows, seven for we you aducanumab. have with We attention. close open if page, are very to Thank a

Operator

now you conclude will for Thank you and joining that call. gentlemen, may today’s and Ladies disconnect. all

Biogen (BIIB) 22 Jul 202020 Q2 Earnings call transcript