- Earnings call transcript Q3 2022

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

Operator

Good morning. My name is Jennifer, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Biogen Third Quarter 2022 Earnings Call 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 Hencke, Relations. of Mike Investor Head Mr. may your you Hencke, begin conference.

Mike Hencke

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

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

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

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

now question. will of we ask kindly I limit the to portion to call, the the a Q&A one during As reminder, that you call yourself Michel. turn over

Michel Vounatsos

is exciting thank everyone time and This for morning, Biogen. you an for us. joining Good

Mike for advances we and to begin and progress discuss mean performance. what then in this like filed, made financial our we our Priya reviewing in continue quarter will to review Phase across guidance. we be year developments our raising are R&D, they to key I are which recent will third we and believe pipeline, the XX to would addition programs pleased our Biogen. includes In execute full quarter progress, by X important

First, X Eisai, were to we Alzheimer's announce the results excited of Phase the in study with early positive AD, together lecanemab from CLARITY disease.

achievement been today, forward Alzheimer's years, For readout Alzheimer's And biology insights treatment as Clarity trial has AD CLARITY meaningful a clinical celebrate design. new lecanemab's from positive profile, key disease, over and the the which in Biogen relentlessly The illustrated therapeutics patients. XX results provide benefit we aspects we could new disease to incorporating in of working both significant several believe bring in clinical disease. AD for of a

in decline six First, lecanemab an study administration reduction clinical disease-modifying the over significant as months, as which consistent early the showed XX-month absolute expanded a effect. statistically highly on basis, with period

household all as well positive includes Second, home. and performing out the as activities merger of key conducting was tasks, such personal study of endpoints. finances, of traveling on independently This cognition living daily secondary as

lecanemab Phase approved plan has Third, here. in believe to and goal of the to therapeutic the accelerated build we on AD, QX are regulatory studies, with approval X assets where, in first within important in days, zuranolone the progression plan pre-owned This the important action, where of be upon of filing diversified for to depression Alzheimer's disease. potential other results in expected are Phase includes for making early X the clinical-stage a and Eisai's treatment. postpartum the therapy end with together access as continue oligonucleotide observed approved, mechanism rate that depressive slow treatment profile major an BIIBXXX, Japan was disorders, Alzheimer's novel treatments. underscore not new We continuing have that believe that, has fight The BIBXXX, Alzheimer's. zuranolone, antisense to XXXX, includes to pipeline across progress CMS decision targeting US, to of engage of two against forward tolerability disease a AD a to they advance of Sage, with January opportunities Alzheimer's the meaningful regulators Alzheimer's for safety could ready consistent with as This the depression. significant. Eisai we our year, as area and stop efficacy Clarity Biogen with eight and areas, our But working look advance We and Clarity the molecule. next as depression, remains a learning's unmet current X approval to by and Biogen the need FDA people if to of three a both clinical will new both We tau in and ensuring we EU expectations. we a traditional continue small be pathology, medical by globally potential file With

accepted has FDA and accelerated our filing SODX-ALS priority granted review. the Second, in under pathway, approval for tofersen the

follow-up functions, meet on longer shown not and quality decline that who measures, experienced of strength lung primary at muscle life. tofersen rate endpoint did has slow six study of key clinical a including the While the remain months, in patients

near-term point programs results and us XXXXs areas and and launches for embody fatal the franchises biosimilars, Parkinson's these position in five by drug that are recent mid lupus We we and as late X. have are along We made next and in the drive of such that forward a disease, to by and truly growth with neuroscience. CNS with to year. April key expected disease, additional Overall, such all advancements new an we key growth believe look developments encouraged XXXX. Furthermore, being have see FDA renewed believe potential development, in in decision Phase drivers debilitating stroke, discovery in opportunities, to by we currently the to of this potential inflection in these had an

detailed as the wave leader work been has and portfolio we progress next remain where four our neuroscience studies we are immunology Biogen our usher in to also a capabilities area, update to on lupus. in R&D. turn while and in late-stage we have in believe the we years, expertise positioned specialized of will over this Priya For therapeutics expanding in recent more that call I to in well a now new advancing for CNS our

Priya Singhal

Thank and everyone. good Michel, you, morning,

As past advance for renewed Together the to order achievements filed disease. results disease. a change of quarter the endpoint and exciting early therapies Eisai, CDR a was announce disease. that baseline to Sum and growth patients difference Michel R&D representing endpoint by on Alzheimer's of our on are clinical of excited in deliver The positive mentioned, of new with Boxes, a company. primary we decline potential Starting study study for placebo lecanemab were this XX which evaluating measure are which meaningfully Clarity had programs, of of CDR and impactful reduced The XX%. with very we function the drive the Phase Sum several XX study, Alzheimer's X.XX, the the Boxes of X treatment the pipeline, compared in includes Alzheimer's lecanemab well-established met XX months primary in cognition from AD at of in with

as caregiver-rated the January statistically that onset as AD exerting approval in publish study Sum to could reduction brain, as pathway we on with endpoints, We November the has Clarity lecanemab approximately in includes of Boxes significant a highlights expected findings lecanemab of The effect. believe filing also following additional This to study living the highly Boxes this This confirmatory that FDA currently key applications as relative a the of EU and clinical of as placebo. expected in been the patients. QX a intends also end incidence CDR basis, of modifying CDR Medicare accelerated expanded lecanumab lecanemab. be rapid a amyloid an engaging CDR efficacy review present when marketing Furthermore, study assessment as placebo daily impact by Japan possible, of in of versus on was the QX We blocks decision to for ADCS-MCI-ADL, benefit to disease of effect is potential for and secondary maximize also in journal. by FDA XXXX. efficacy will for at results the to an such a medical of met accelerated a a change well. CTAD lecanemab AD date the these overall as lecanumab's as authorization combined a months. under Eisai a and significant for The US of end in positive reinforcing significant the cognition of clinical centers with a access study early suggesting treatment The We activities approval Sum services XXXX disease. reduction they leading a six on in assessments statistically results, observed work and under demonstrates verify versus Sum the Boxes ARIA Accordingly, XXXX, with the function. the on the is absolute the along traditional of over filing placebo. serve in PDUFA file well Eisai Clarity of that also modifying and agreed period believe all expect Alzheimer's the as approval. XX-month soon as of XX%, Medicaid has will disease X, Eisai with observed peer-reviewed

pre-clinical which before advancing a the evaluate to study but includes, of with are lecanemab amyloid for administered regulatory in impairment. engagements, X-XX also access these onset program Beyond earlier together and disease, the Eisai, present AHEAD is we lecanemab, pathology development when cognitive first, when ongoing comprehensive

regimen simulation as while data a AAIC comparable subcutaneous milligrams of result lecanemab of presented year, lowering of modeling I that well investigating IV development formulation potentially from potential the IV dosing Second, the comparing ARIA. over administered fixed as subcutaneous current dose Eisai frequency exposure weekly maintenance the bioavailability versus lecanemab. reducing incidence with And formulation time. XXX a study Phase may and goal subcutaneous efficacy of earlier and a to this of the in data dosing a the dosing potentially illustrating At

now hand, long-term. in results disease over on Alzheimer's we the leadership focused these in With our position maintaining are

pathologies, We broad as amyloid of range targeting a Alzheimer's have an portfolio a multi-modality and multi-target industry-leading both portfolio tau disease well addressing pre-clinical biology. as

Now turn novel MDD, in Biogen XX-milligram includes to patients the ongoing expected XX-milligram PPD suffering for are time responded where supports people an we Study XX-day a cohort. regulatory both quarter, original and depressive which and US potential, days of first We and cohort median the for showed SHORELINE repeat year. the Sage potential zuranolone and This the these as treatment longitudinal postpartum if support a treatment to that XXX to treatment open-label who data approved, new updated sorry, believe neuropsychiatry, work treatment to onset this first this for presented will zuranolone's to XXX I to and filing Sage completed disorder medium the depression. as the major -- further time that I'm single for with days for analysis by new depression, was the be for of a from continuing in zuranolone end advance to MDD meaningful data

we has quality transitioned currently published label strength to those the of application by initiated function, recently request showed neurofilament, portfolio. a Medicine ALS, accelerated submitted review. was Phase which and under its extension tofersen progressive responses in tofersen Moving rare approval evaluating across neuronal considered and from who the critical and therapy. VALOR of of open who data to genetic by at tofersen targeted which major no led New on rates placebo that SODX-ALS, In extension published in slower versus FDA reduction Journal review. and measures will injury to in neuromuscular sustained VALOR XX-month later. open-label neurodegeneration. additional of the filing FDA the information data time pathway that to of accepted of a The The and our start the robust marker of decline to the months England a life Furthermore, require experienced study the Subsequently, with from six a the tofersen amendment July, FDA, the III for patients priority form muscle tofersen

with small been has BIIBXXX confirmed movement In together XXXX. inhibitor. an period molecule now our April by Phase late-stage LRRKX individuals As XX, FDA months for trial a with expected second clinical study by result, in The mutation. evaluate will Denali, we review X three extended a pathogenic LRRKX the decision BIIBXXX, LIGHTHOUSE a initiated with disorders,

also idiopathic this is believed in and underlying Xb implicated function activity regulate LRRKX Parkinson's which advancing Parkinson's earlier that lysosomal pathway LUMA we Given disease, are year. biological in Phase to we the disease, initiated study

erythematosus, results of evaluating X/X Litifilimab of study CLE. in Moving met with or in specialized or X for to in two safety Journal we and both immunology, immunology. cutaneous late-stage X X/X the Phase separate efficacy Litifilimab on our The announce mid SLE. LILAC which of of which in were detailed parts study as Phase primary of systemic to were endpoints or study in the Medicine. England lupus includes in New The the in and pipeline X and to dapirolizumab study, the individuals also Litifilimab upon recently pegol, two CLE lupus We three specialized BIBXXX erythematosus UCB. Phase Phase are for in SLE, developing The manuscripts excited Phase CLE one with initiation published the studies collaboration prior builds

to broad programs recent and deliver effort, and better or employ on at conclusion, in these to This ability new also target. characterize of for elements I unmet the ongoing the approach combined our in over biology exciting Together, to has Looking disease modality in potential need. right biology, use a principles, the includes as the will important target Mike. call SODX-ALS; pass to potential of of disease This biomarkers Biogen. prioritization late-stage In readout engagement, to and to mid exemplifies well with validated have success of the study now we therapies specific a targets number depression, as Alzheimer's increase opportunities in with the areas to genetically and believe our area the ALS. we significant ahead, probability disease our that Alzheimer's, horizon. proof-of-concept disease novel a includes progress believe the therapeutic of and focus on R&D our we broader stroke; initiation

Michael McDonnell

constant EPS good Thank quarter morning note and of XXXX. at financial was full all some was third Priya will are financial the comparisons of which of and Total update quarter currency the quarter the flat a X% actual $X.X which to $X.X inclusive billion, third OCREVUS actual you, million everyone. XX% decrease XXXX of X% and revenue, provide the XX% at Total currency. currency versus quarter MS royalties, was Global at revenue of from to outside currency. diluted our $XXX of billion, guidance. in third was XXXX. XX% currency, in decreased and was Germany. I at erosion decrease TECFIDERA an at third at generics of saw of the constant actual our constant US versus of quarter performance currency. highlights for and an that continued the XX% We third primarily and the impact year due revenue in for generics a Non-GAAP Please US, TECFIDERA $X.XX,

Separately, in adopts TECFIDERA protection EU. We if Justice continue court European approximately XXXX. dosing until advocate is opinion. to the Court of February TECFIDERA expires to enforce market new launches typical. advisory granted patent, a the to least are have we understand There of our opinion. is opinion see would months that court generic to issue XXXX, non-binding we to actions Earlier decision, recently month, the deadline statutory of general which no We the European for five expect issuance of the issued in advisory after this but at the the general's final three advocate its filing

do with continue have been to generics protection EU, obtaining some unsuccessful including to asserted Germany We injunctions the offset increased TECFIDERA's the either by States. oral being the in or patent, Until, statutory the we of France. and segment increased higher VUMERITY VUMERITY in injunctions entitlement VUMERITY by can volumes, in the in not at the both currency. in allowances. market where our XX% preliminary we XX% and Global market revenue increased at countries preliminary of actual revenue $XXX pressure United in successful successfully and contraction currency payer impacted countries and partially and in is constant place. affirm of US discounts others, sell have million X%

to supply continue with for to potential work address supplier our manufacturing We contract constraints VUMERITY.

XX has now the decreased and and goal US, issue currency. launched higher over of with impacted discounts Outside in ensuring in the the were We a anticipate average and EU, inventory identified We by required at not approximately pleased to currency new allowances volume. TYSABRI actual rate adequate at working X% markets rebuilding conversion $XXX X% TYSABRI negatively growth good we now and launches manufacturing lower on was changes necessary currently supply Global formulation to XX%. the revenue US revenue patient an of in are XXXX. continued do focused as constant secure the and root well see country the which resolve uptake of related of as supply in been with subcutaneous XXXX to regulatory are reinitiating shortage have cause million and approvals. implemented

Although, Global Sandoz XX-K. States. or patents those continued the related have actual suit the for and XX% expired, oral impacted our from and the million to and listed revenue TYSABRI injectable at the making United to currency using high of IP, currency at composition platforms in enforce filing shift we matter continue including was interferon We'll this patents have TYSABRI, XX% by of other including of in the constant therapies. $XXX decreased efficacy against to

in revenue believe of by the partially we timing US, due potential excluding and over the well certain increased markets grow negative to to X% of In X% actual currency SPINRAZA may of $XXX we year, revenue constant stabilization SMA. believe declined and US. SPINRAZA flat and the Asian the prior time. dynamics, some versus increased in was pricing has to million United be as Global to offset volume Overall, that the currency. SPINRAZA Moving as Outside shipments. States, currency the seeing growth signs at impacts, revenue positive we competition at continue

was of currency an X% as well negative in declined Moving We and at increase which as constant impacts. Biosimilars by at currency. unfavorable currency our saw actual sales to pricing volumes, million offset $XXX X% business. Revenue

expect XXXX. of gradual to the due year. to biosimilar X%, competition. continue meaningful more BYOOVIZ prior Revenue in contribution We which by million $XXX flat was continued to Total begin declines royalties anti-CDXX revenue a RITUXAN versus with launch increased OCREVUS of revenue was expected offset from

Now balance sheet. moving on expenses the on to

of cost sales was charges. which non-GAAP quarter $XX idle million, Third capacity includes $XXX of million

idle expect suspension product ADUHELM. pressure largely and from mix shifts drug we in forward, product gross due charges on potential the manufacturing for resulting margins of Going further to capacity

closeout of R&D development million $XXX Third third SG&A quarter quarter Non-GAAP quarter payments million. SG&A the in million compared which third XXXX, driven related $XXX as This business $XXX costs. expense compared upfront approximately clinical $XXX was in to trial was This was expense is XXXX. transactions as well is included $XXX savings the to decrease initiatives. in million cost non-GAAP by The million. of in primarily to

operations. the of proceeds the average initiative. for one and of from of $XXX million. received third quarter, $XXX expenditures collaboration our a of note, common $XX $X.X quarter, million expense our the $XX primarily debt footprint $XXX Samsung office other in quarter marketable flow Of we as primarily share. million billion million and $XX securities, optimization In with at price million with driven Bioepis. and repurchased debt. We in the million, Third net of in in Non-GAAP $XXX were interest part of free per net quarter approximately generated $X.X in Capital an Cambridge cash cash million, $XXX during the third company's billion We cash sale the ended expense net X.X million profit collaboration was was was quarter in flow sharing of driven our million by by stock expense. shares buildings $XXX we from

previously million litigation. qui resolve $XXX paid we the and to fees plus expenses October, in tam disclosed Additionally,

in April million years our receive next capacity, the financial we additional growing from very in over including invest $XXX financial over $X next stake undrawn significant including position business As year. approximately to strong a a with the sale billion credit Overall, Bioepis, to an long-term. in $X.XX the Samsung remain reminder, due facility of a billion equity we the cash and revolving of in X.X expect

updated to turn few guidance, me our lecanemab. let Before about a words say I

opportunity important to We Eisai global XX-XX are sharing a this profit collaborating with agreement. on under excited be

component may has earnings see right Biogen revenue. in presentation authority. revenue After the other of be quarters and co-promote booked of lecanemab initial with other who share of The Slide losses the for the lecanemab Eisai final profits co-commercialize Please our XX As considerations. of decision-making as component launch. other approval, to in a negative a reminder, be has accounting will our or

discuss our updated Let guidance. full-year me now XXXX

guidance $XX.XX performance $XX.X We are billion range and range to to range increasing to new $XX.XX full-year a of non-GAAP $XX.XXX result is billion cost of new billion increasing to revenue from a our our guidance our diluted previous This $XX.XX previous a from topline of $XX.XX. year continued management. EPS better-than-expected $XX full our range guidance $X.X of billion and increase of primarily to

Our expense, prior our guidance unchanged and tax ranges SG&A R&D non-GAAP are rate expense, guidance. for all from non-GAAP non-GAAP

net as seasonally will a higher also we As continued core revenue pleased of activities. we for in for reminder, XXth due as business to press guidance In the competition, our as of due guidance well RITUXAN to year, spend assumptions. execute in be This and release the SG&A rates raising typically assumes that biosimilar generic continued of the to a important the September Please continue declines across see our are erosion assumes entry. year. financial guidance see guidance This other financial hedging exchange summary, remain foreign in fourth revenue TECFIDERA our for quarter. of remainder effect to well

readout portfolio. build to across potential diversified over time we lecanemab our to a immunology, are growth has believe and the continue about multi-franchise to recent We specialized and the excited Biogen neuroscience, biosimilars pipeline as return

call questions. Session the shareholders. that, As remain will now for for Question-and-Answer long-term on with always, we focused creating value we our And open

Operator

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

Umer Raffat

Eisai. your There's curious it. Thank I been like And there's to was or to really very any contractual commercialize disputes much. on just of if Eisai of a question Good allow a investor status relationship morning the guys. questions of that lot speak you had you to you I status if not on sort the could that. relationship, anything sort and the expect of of you with

Michel Vounatsos

tell Umer. more is relationship co-commercialization the basis. in regular many when question, years. I add very The have the being the counterpart we And with and can opportunity on that once meet -- you I solid very do to the for our that will since to my Thanks align a I is very to -- co-marketing closely. together you determined. working something? the and discussed speak coming Mike, is are team solid. overall, The not and is yet but relationship sound do want days. And

Michael McDonnell

No, that covers but is would more the it. I detailed work Eisai for the together will be obviously, that shared. decision-making think final I strategy, And study we're say commercialization a as share. CTAD on upcoming it presentation, profit we where results has together, rights, excited XX-XX

Operator

go RBC with to next Markets. from Capital Abrahams our question Brian We'll

Brian Abrahams

and Thanks I I'm reimbursement approval? in partner's a taking the whether question your accelerated lecanemab And what and results CMS with full high-level I'm and versus congrats Clarity how morning. requirements discussions, views accelerated case evidence data. support satisfy for AD you on on the an guess curious CMS' of reconsideration on NCD good from latest based quarter topline Thanks. access are wondering, Hey my an lecanemab ongoing on approval. the you envision your to for would

Michel Vounatsos

this for Thanks question. important

depends it think the to all of the I strength evidence.

and primary line results with We the on top pleased are the very secondaries.

considered be forward. are and that all in to publication the for for assess and path will imply of by Priya? will looking order CTAD that CMS, evidence a the We coming level forward

Priya Singhal

of there a That's just And -- the that I'll are right. add a that Michel. are is scenarios you, exactly there outlined in couple NCD. Thank

that, essentially on is CMS-approved So NCD strength is non-overage. the of a rigor affords But I that coverage the it that which which randomized in comparative for indicates, kind of rigor trial, of prospective of that only covered in registries. The and approval, the depend the study could controlled options, the approval trial the a strength traditional will be approval. of for study, essentially final and including scenario, think, a traditional accelerated it's randomized there situation controlled is range

that about in of we confident very sense, evidence. So strength feel the

met As manner. we in also to you significant about had And XX% X.XX, placebo endpoints translated an a of And statistical the lecanemab. treatment know, of were endpoint add difference with population. that primary secondary met XX% all underrepresented highly would a versus we with I addition, which in

engaging we believe results already are discus very The with CMS encouraging. it's So seen, that to designed Eisai very this. rest be and well remain the to and will is

about the You so final reconsideration, out that a would was in could NCD be add urgency note potentially reconsideration I'll -- did NCD That that that considered. just with specifically asked and CMS there, scenario a I a could without this months they precedent from think And take that final put the that with historic to full studies. comparative nine act prospective would would XX for act the in perspective. But urgency. sense, said have they a need be coverage

for wait I and continue the engagement. we to the data need think So CTAD

Operator

the from line Goldman Richter comes next Sachs. Salveen with of Your question

Salveen Richter

morning. Thanks taking for question. Good my

lecanemab walk back business you're just On can about how us the data, development you and through the portfolio prioritization? of thinking

Michel Vounatsos

we Obviously, MDD BDs strong. have of active I are and products remain do XX And the remarks, getting we on BD. and can we said ALS, the tell we AD, as -- for IIIs very that you filed in PPD. Phase prepared portfolio evaluating during is prepared

Priya making So BD we And the are We've be week be progress. all are Mike? is the are in we deals few to and evaluating than always every active. more we continue and improved. made Nevertheless, very very the XX prospects, busy. we past but portfolio years, on because can table

Priya Singhal

Thank you.

we've both be when. of during And scientific as back, believe great just as the our a evaluation portfolio mentioned question. the up also of that's have We we space. to biology. and set a Michel done the see think biology I stepping hypotheses, lot of the ourselves in we leaders remarks, So in to what terms that And Alzheimer's the able address the

success of lecanemab. in with that's think with we've results also Previously, I terms had we've the So now the and seen hypothesis. A-beta biology, aducanumab, the

had addition, work. did tau, against not antibody with study we In the own monoclonal our which

Phase our tau hypothesis with we test the post-translational with are initiate all of address did we to that is X forms an extracellular So, oligonucleotide antisense tau. now and that BIIBXXX, which will positioned

antisense an we Phase inhibition we have BIIBXXX and So we addresses aggregation leading enzymatic [Technical have Difficulty] in believe tau believe of aggregation. which we addresses X, a oligonucleotide. Also, tau

So, looking tau biologies and are several targets in preclinical space, terms -- from the of amyloid very the this carefully Behind basis. trying all have other modalities. in we that, that from are we also and we pathology really the also the tackle at to

very with tested already So, disease. comprehensive And preclinical I'm pleased have Alzheimer's in I we lecanemab we approach. regards being to when, think a very that have

ongoing, do address that's you -- study what happens So, intervene amyloid will the have prior a with you but symptoms. which have therapy, aggregation an anti-amyloid that's you when don't when already

it's I think a So, approach. very comprehensive

not We here. to going are stop

targets. In We will very maintenance development and look And to our lecanemab, at finally, think BD is Phase obviously continue very testing on And continue development the plan. open-label in at important. Eisai dosing. internal be I we with are important we're two this. to looking the lead attractive aspects X extension,

frequency the the And So, at looking decline open-label Phase III subcutaneous clinical extension. in to what's stop. to progression are the right we preserve continue development

Thank that invest think very So you. will we And a this continue to comprehensive. I to think overall, I will space win. it's very, be

Michel Vounatsos

anything BD? do add Mike, to you to want

Michael McDonnell

covered only would add. you it, add is just think -- I the thing would I quickly No, I that but quickly just

M&A, not did way not the into should in you read new collaborations activity quarter anything You see of the during BD or that.

will we tend Thanks. to to continue a be very a of look expect at should pipeline the future. deals. you have and lumpy more in transactions to be robust that there fully does variety It continue and We

Michel Vounatsos

looking we and we prominence and beyond. position lead at So, acquire, said all at are as process, neurodegeneration actively assets a very more Priya in and targets in privatization AD, in the could but takes we are also eloquently, to our

Operator

your Anderson next take We'll Tim Wolfe question Research. from with

Tim Anderson

I actually relates it still a earlier being have ADUHELM, question and on about kind role with comments lecanemab your contemplation. under of to

with I lot but anything be under But impression and really a what think not I aren't hands are the washed of your ADUHELM. hear, case. that you've all the doing folks from may

Eisai. could on It's instead be CMS why ADUHELM. figure reimbursement me that the you source out may a for It and sounds wouldn't active you forward still you path version APOEX be be still intuitive to pursuing with if and wondering still And of true all-in if Thank get carriers. subcu of be I'm trying a You're a not why you. product. to is just like with may to tension that lecanemab

Michel Vounatsos

EMBARK So access the all-in aggregated have, of [ph], lecanemab we'll partners removing regulatory slowing on to cognitive AD we the the [ph] in Priya the the currently more be important, we form that. process. and this Clarity And And is to of down great can we with is what will shown dosed with this on and decline. the secure of the patients have associated study. together ADU, the have be will very brain do that we beta patients after with can a finding reinforces being and everything the Nevertheless, with we that product say

Priya Singhal

made I and any aducanumab, continuing a What I'll to is we we don't decisions. are haven't I'll at lot -- to actually look add. Yes. have say that

very an many data to now, is patients be anti-amyloid scientific have and set who believe For the for we years. been going community. EMBARK to on aducanumab that therapy These are the valuable

study. In first is addition, accelerated we aducanumab a ENVISION was called that the the get have this and given to post-marketing approval, requirement product

So for continue. ENVISION EMBARK now, both and

Operator

Your next Sandler. Chris with Raymond Piper from comes question

Chris Raymond

thanks. Hey,

Just maybe question related one. last to a the

wound how launch approval you the How through on approval? maybe ramp the commercial maybe So largely should about here learned to infrastructure and here. lessons talk walk lecanemab ADUHELM from we Thanks. potential infrastructure from And full ADUHELM you move with us down resource your January? this accelerated in think for come sort as spend of a about

Michel Vounatsos

start the regulatory the between been NCD the and timeline It the lecanumab the based have decision force ADU, and will on This and for readout reasonable and on. on gap question. Thanks will not then board. process add reasonable. a was Mike will keep I not to large

had So take choice that than the took. we actions no to we

approximately company is in there in the Europe the since continent the approval the accelerated time we approval Japan assessing, in a in have same strength, full the together year. each new the for the with page. early intend US, we of file considering each And are Now relative to benefits the partners, should strength and we at --

investment, the there. yet we are but completely not planning are We

very do we'll and paced that from manner, take and controlled we'll in So here. a Mike? it

Michael McDonnell

way obviously XX-XX as share have commercial continue we a openly. final in that better learnings have situation I ADUHELM -- And that – all are the that Yes. I it that just spend the way saw didn't we much share. be ADUHELM things you I revenue Eisai do on decision ramp you'll obviously, feel we able will in that a will They gauge will that very we've to from rights, will But than that would discussions I a that on in to Eisai a say saw a highly the add had spend would on able you we and number -- it we see to profit proximity confident strategy, that, it's said. feel with that that direction as revenue commercialization There the to gauge ADUHELM. in there we'll anticipated. better ADUHELM the were on than have and go what proximity of ramp confident to be do

Operator

Your next question--

Michel Vounatsos

this And if and say not a product may, case. have say of ago couple a launch, an process will and that thought -- is new accelerated years mean us. I the was of ahead I we we will I What that will

So, was here up. now, very scale resource be and controlled have much we then a the that process we way outlined we'll in the to company's spend new

Operator

from Matthew Stanley. Your Morgan with next comes Harrison question

Matthew Harrison

question. significant get the lecanemab and is for I results. part the of for drive address taking which we the lot a that from I Thanks topline morning. Good wanted about to subgroups outperform a another investors, to question populations think or Great. potential certain

was just of you CTAD? case, subgroup Thanks. out have can certain that the that major a maybe for that topline, confirm, example the So, or called in if response you if the was should about into going driver that would think a we how

Priya Singhal

question. the question, can that I Thanks Matthew. for take

met say p-value overall, with a and X.XXXXX. of of the AD this just CDR-Sum which was So endpoint, I'll its Boxes was primary that Clarity

very significant. was it highly So, trial. very, And this was a large

X,XXX with all function. and endpoints, participants about was cognition secondary were it which it the underrepresented and -- domains including met independent of population So, its

and feel that encouraging. So, positive they're the very, are very that overall, we very results

believe just we've we may what exactly that by overall, what think primary feel subgroup that the and to not very have at able comment I this and you Eisai, have we more see. endpoints. wait not I topline. see or of about encouraged on seen we need to details analyses the be for say won't to the I by wait, the on may But shared Now, to both CTAD would and been secondary we point, details

I that. think we have for to wait for CTAD

Operator

Your Skorney next question with comes Brian from Baird.

Brian Skorney

Hey good taking morning for question. broad have wondering could that lecanemab. outline for timeline any everyone. was you I my Thanks if subcu you

and have or wondering have the dosing looks forward? maybe just this a who be seeking with patients approved, think might interactions from you -- initial chronic IV as to and initially like on you're more over be what you subcu initiated And label a time? Just like learnings switching pathway get your that would of where any period to could FDA applied

Priya Singhal

Brian. you, Thank

is engaging with X And comprehensive also very being tell formulation that what for you this in pursued the overall, a development We're is important already the subcutaneous is clinical -- can open-label -- also FDA. Phase lecanemab. Eisai the extension. has plan development I of So, is long-term part

there just the bioavailability Phase say has discussions would So, data I been publicly. that already are X shared lots of ongoing.

at in So, that the is I timelines not But fixed dosing, being already currently are need package been shared has that. And details weekly else they the the as I shared. might the of remarks, and what looking my and evaluated. this XXX-milligram mentioned

shared, And that appropriate. would just that for so important I say share it it be is to a it's will very we and ongoing. is when wait let's But and endeavor,

Operator

Michael with Yee comes Your from next question Jefferies.

Michael Yee

Hey, thanks. Good morning.

groups, you about from about or and wait just if guess comments are have can or CTAD working what to whether and that what ADUHELM will that having push or whether see to fast. reimbursement they interactions, maybe a guys clearly year data, Going urgency, for talk what you be CMS that do act hard ago approach whether pathways of a patient back Thank you could types there's CMS with they situation to I the any, you. advocacy change to

Michel Vounatsos

has lead payers. the has and And what that initiated know regulators already engagement engaging So we Eisai from CMS. is in with Eisai

So at there, for I But responsible the details. which provide will not stage, engagement the they're important. activity. more this most this is is And

Operator

Robyn with Karnauskas Securities. Truist go next We'll to

Robyn Karnauskas

Thank you. My question is two fronts.

with this mentioned, has And that think that share and you lot a -- you to a big -- that space. up have that that small is will right you elaborate hearing a more a trying have Lilly there? presence the very we're revenue. to you're you now Mike, in So doctors I'm just And ramp said, we'll mind for of Because interpret Priya. tend line space. in to in bit you you going what question spend Can little competitors

a of that We trials also patients a you not tau have hear pathology that there. to want do questions beta – in may plaque tau couple with that already

Michael McDonnell

clarify point I'll just I made before. the that Yes.

up point ready a that is infrastructure large that, would we wouldn't that hopefully, goal go. experience was As to and a approval we would received significant and to priority we we launch XXXX, of that repeat making strategy a I obviously, And had that then wouldn't June will the with the and launch one. first an be encountered infrastructure the commercialization position. possible place And the when like have we obviously, in obviously, situation be be was supports that the delays delays. Eisai along us, then infrastructure that best successful that. And in appropriate launch. the we we'll had and and the to there, primary we built in support develops put goal ADUHELM, that That's right with get And hope in the

ADUHELM. it on spend ramp in you that front see the gap that revenue, so would a of it would And did have wouldn't but that

Priya Singhal

can can to And I add that, add I Robyn. Mike. Thanks, that. to

doctors profile really really, result important can clinical also the be plaques in here. like I'd going perspective. of demonstrated And add to of space evolving I is a be going think think really that highly this very safety lecanemab impact. is to mind is and terms removal a rapidly a In has And that important. this from scientific I share, the that, obviously, to

lecanemab, of for consider. to And to efficacy ARIA together rates be be with example, about to XX%. are think expectations. I going that For we've this, the seen important doctors are with We've got this results, within that

I So data is a the that going little think anti-amyloid therapies needs data the bit share think other I depend we I overall, before will question maybe would was from the say seen decide on the what meaningful. and to the be mind the about while launch, be to more

We've a this pioneers. The and need very need think is the here I think very, complex other encouraging that as very see unmet patient broad is we high. very ourselves We got and and population is this piece data.

[Technical it. question, then So, a place Robyn, we to And very you it's I think where Difficulty] can patients. quite important didn't catch clarify on difference please we the second that?

the You towards up broke end.

Robyn Karnauskas

sorry. Yes,

before So, for tau you want you tau other In some pathology, give that scientists plaque words, tau. clear to the work may believe not alone.

actually are you ongoing, The plaque biology. work A-beta not it an need all how drug think may with XXX, clear lecanemab, thought combine they may actually we understand chance is there because lecanemab? -- You actually a on trials with to the that do like need now you like that that that these to including

Priya Singhal

it. Got

I key. I'll to step pathology just amyloid that think obviously, say very back is So,

aducanumab, we We aducanumab also on did potentially impact tau and that such. with phospho-related believe upstream pathology. data with of show it's tau And our with the --

that that be to cascade it. here already question think going approach methodical one overall systematic not that's to it maybe could said I in intervention, very important. be think how the to So, Having we we're that and very different that, approach the that to, this be and Alzheimer's matter. be of disease that right, you're we The I about very timing of may which adequate. going be is trying of future also a spoke type is is But

of publicly This year result this based could two results of I And to impact. data. that also clinical before Xb in in based the have plaque, removal about from on demonstrated and stages three Phase preservation and to that progress So, that with has X, the type aggregated know they Alzheimer's. patients severe with there Phase we've of modeling, Phase which on analysis that this significantly years shared is of a will more X do from think data also and this Eisai now this they said lecanemab that modeling I result, earlier data really could is

So, it separately, I tau. where we and addresses from encouraging progress. had significant think of trial that believe are And And forms results Phase tackling the BIIBXXX, are Xb reduction our then dose showed making we very we time-dependent of which we we a tau. all

you're So, we're But initiating the right. in X. a now process absolutely Phase of

looking can. many in the at that We way we best we different will be approaches in how patients can benefit

all yes, to we need systematic need and So, need to go to biologies but considered, we this. step be wise, be about

Michel Vounatsos

of is be There of welcome -- that all And is much if terms I companies. so mind the efforts built I other may epidemiology add share, to we large. the so in on the infrastructure

leaders, Specifically, about I lecanemab, some of engaged scientific have and with you. you that know

engaged Difficulty] clinicians. and We [Technical have with

that patients months make the end feedback difference But will six the of expanded effort from efficacy very hear. safety the for period and every is in the to compounds. the this think day, the prepare at I the XX-month market at it we And what the we the over will between positive study a need. of and stage, at be welcome

Operator

Your next question comes from Jay Olson with Oppenheimer.

Jay Olson

the I'm for platform results. your potential lecanemab plan leverage AD congrats Beta question how TV thanks the Clarity on you A antibodies, Hey, taking for their and including the and curious for to and ADUHELM. Denali with collaboration about

better Now the have of antibodies? nominate therapeutic candidate the you a you. to results, improve clear positive is think what program? profile Thank Beta penetration could timeline brain from A do And we that the TV DAD

Priya Singhal

several the Jay. move on make we're as carefully, Denali at can't build that see looking biological But and comment as on to on you, you. we'll we've we seen. everything very Thank actually question. I of and I It's the TV data it's table. across we partnerships and hypothesis What We'll platform. strength and good the they Thank of with appropriate. our how share be yes, specifically strength announcements the relevant looking become of existing the can you at is these more that everything very portfolio, and a are is looking can our

Operator

We'll Phil Nadeau go next to Company. and with Cowen

Phil Nadeau

Biogen role better setting Good Would because are thoughts Thank data, Biogen's all of that at will morning. on Thanks from learnings question the price premium lecanemab? decisions, play launch. And of lecanemab's in on price? price the discount recent commercialization the our say a on you. has follow-up to aducanumab ADUHELM expect for pushback? the of questions. you because Eisai A final a appreciating what What taking to

Michel Vounatsos

interfere cannot As decision, and this process. It's you with will Eisai's can we anticipate, we not comment.

Operator

to Goodman go SVB We'll Marc next with Securities.

Marc Goodman

there? to more you dynamics you Something SPINRAZA, what just, give confirm, the weekly, Priya, or And is on is were? the still dose about the Yes. regimen? Could going little a be just can that XXX OUS subcu price dynamics the then increases we're positive us we're pricing just dosing one color that on working

Michel Vounatsos

question ex was about US I think your SPINRAZA?

Marc Goodman

Yes.

Michel Vounatsos

the Yes, being slowed SPINRAZA momentum dynamic. see data the see patients We from the so down two types risdiplam. of plan by on switch efficacy patients, launch of a for from from U.S. is back to But we are sharing reasons. European that we

from So are US. I learning and -- the think we

time. of matter a it's So

rapid Europe, learning very growth should in And price continents for core the US the from by same. not from. We're learn we but And We volume, becomes model believe delighted are US. this of what see the a a results. that other the we terms is ex

we gradually. the product is you results are can the back, ex this believe delighted Mike, we the its resume Overall, momentum to we see where SPINRAZA will momentum by So do want to US and coming US. grow add?

Michael McDonnell

was items, of partially volume Yes. I remarks, growth offset in a out prepared We increases points a few of our few OUS. and the was others, growth Japan, to actually a there strip the was which we a was modest in more due if that there on add, a was our directed that Europe Mark, primarily Germany made had some But by modest price China. you at markets currency volume. competition have throughout and but FX in we than timing there like in the mentioned decline, to did volume and and in the Brazil, that and decline overall, spirit flat. constant Russia, growth just was would places And OUS offset more Canada US question, your basis, we

So FX modest then declines kind offset of against had you than going to you by volume and had you it, unpack increases OUS. price more the slightly

Priya Singhal

just point. I'll second really on And wrap the up quickly

kg you your is -- the had, intravenous the to think recently has study that the And XXX-milligram that now announced. fixed second question biweekly. I Eisai XX-milligram dosing, dose communicated was listed that auto-injector per weekly it's the for actually that also equivalents dose show

think correct point there. question. you me had in different I the that a Please if was

Marc Goodman

No, that’s Thank it. you.

Priya Singhal

Thank you.

Marc Goodman

Yes, thank you.

Operator

Chris JPMorgan. We'll to Schott go next with

Chris Schott

with is you subcu for think around bit the I Thanks more Great. commercial standpoint? is be just much this you Thank do from lecanemab the about aside, paradigm of a extended for or going be little and therapy dynamics will you this challenging dosing so maintenance this programs? infrastructure this guess, could a IV not we you. you're short relatively know Can for I dealing but questions. timing, be talking that a two-week to the talk reimbursement how time? And that period as wait and current window an about for envision the using

Priya Singhal

Okay.

with data seen kg biweekly dose. good XX-milligram per I we've very So, the think overall,

the I early endpoint Clarity I basis and that on primary until is that the six seen months expands relevant is that here at six AD. months, there's important as in very, titration think, point the think very, as separation -- is no XX-month an absolute readout

data. disease patients to built this seen So, around be physicians. been say for will encouraging actually as very quite important of all infrastructure out, this it by is the Alzheimer's and would I be has that

which we We is we to having mind, premise as But doing the keeping So, and convenience see it disadvantage. trying Eisai necessarily are was in it of effort, leading subcutaneous don't said as the question. this patient make we don't that sure are everything. the that disadvantage, that, if see development. a is a we're

it these build very beyond comment these can't long development a subcutaneous. in topics be intravenous we're and high out we aspects at level how to clinical it carefully at that program with will would I when at But looking level all on granular all as So, the transition and mind. also a

stages, two early in important be it really believe be we weeks. clinic So, in for patients every overall, the will seen the to actually

Operator

Your Matteis comes next Paul question from with Stifel.

Paul Matteis

ramp neurology Where based so you on is you Great. the I capacity up field in infusion was today? be access to the over think time? ahead how today much. Thanks how ADUHELM, experience happen it clinics in your there for lecanemab would needs much characterize do launch? to of And wondering, materially with broader

Michel Vounatsos

believe larger. our ADUHELM reimbursement, saw So for on But what We current and and a need shifting is at from that flexible we the was reimbursement. capacity. the system I happened. this adaptable see existing that the we potentially And ADUHELM got some some so to overall, should be has by be there based could shown has time never the infusion upscale learning, to system center capacity that of is adaptability the to much never there

Operator

Your from Bank Geoff next with comes of Meacham America. question

Geoff Meacham

questions. much so morning, the Good guys. Thanks for

the earlier on or of the launch? some spending. to investments for adoption you restructuring the guys lecanemab launch bit can sense trying spend that this of over about the year. that had the little just you I'm you ADUHELM commercial talk of a maybe of for be that made for can reallocated get manufacturing a Post follow-up of next assets kind the course magnitude the – the versus Just lecanemab redeploy a that you year, can

Michel Vounatsos

Mike?

Michael McDonnell

Yes.

manufacturing, dedicated Solothurn first for facility then a a North would which a will Raleigh, and getting inventory say of Geoff. I to Solothurn in And for our Thanks involves largely Alzheimer's new the products, significant Carolina now lecanemab. So facility couple ramp-up Switzerland relatively ready in facility of be question. have the a disease on comments, launch Switzerland. for we have for we

-- is the as And we more extent $XXX marketable, ADUHELM the tied to that had that of as that little to well. the think the speak, the inventory then launch. end we million could it's facility, a of becomes lecanemab to And over I quarter. hand facility heavily so utilize of on efficiency,

So be some there. state that's will the There capacity. play of idle

quarter. infrastructure did there's be say on this to time from a of repurposed NCD we've long product million down. said that about There'll received You commercial take would that saw gap that lecanemab a to maintain ramps. capacity the charges commercialized idle It from was as make before, some incur infrastructure. the to in I the $XX lot fully [ph] just we'll We will ADUHELM. that April too time have over time to as would be we decision, when cane become infrastructure, of that that XXXX not the

So cost $X billion committed. that we've savings most been our of as of eliminated that's part

and the a so the part, infrastructure will that commercialization And Q&A lecanemab, new of a will most for be ramp built. be new End

Mike Hencke

concludes you, That our this for call Thank morning. us. everyone, for joining

Operator

participation. This concludes today's call. your for Thank you

disconnect. may You now

Biogen (BIIB) 25 Oct 222022 Q3 Earnings call transcript