Biogen (BIIB) 30 Oct 242024 Q3 Earnings call transcript

Good morning. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter 2024 Earnings Call and Business Update. [Operator Instructions] Today's conference is being recorded. Thank you.

to conference like to now would turn over the Dr. I Relations. Senior Director Amato, of Stephen Investor Dr. Amato, your may you begin conference.

Thank you. Earnings XXXX Biogen's Third Good morning, and Call. welcome to Quarter

which that During I risks our encourage filings, risk forward-looking a review. to forward-looking factors we'll provide this from statements, you We list call, differ materially to and cause may which comprehensive uncertainties statements. actual in results make SEC involve of our

GAAP as release non-GAAP and related well biogen.com. of other on as call results and results this in between earnings discussed Our the found to reconciliations documents be our section can Investors

We call. posted slides that website this have also on be our during the used will

call, Head who will Chris Financial North McDonnell, today's Chief Chief Alaimo joined Priya and and America, as Alisha Development; President Executive Viehbacher, as well President Mike On Officer; Officer, Q&A. of our by Singhal, I'm be our Dr. Head for available of

and session. questions to move some to We we'll over to will then X make we question. possible, as through Q&A the you get the ask I kindly opening limit will to call turn that yourself us allow as comments, now To Chris. many

But Mike call his with we very Biogen Mike also and significant everyone. Steve. quarter his still you, our for of by of Robin earlier the Also up announced retirement is first and fourth Thank Good we the Steve of earnings to McDonnell, Head Kramer. in a of the I'll plans IR for as thanking contribution interim CFO, recognizing as great the appointment firmly done be will quarter. CFO, this you, stepping and job morning, us later. saddle start preparing this week, successor,

positioned years. over the very future. well has think I last think do company the X I made Biogen So is strong And for and progress significant the

launches well sequential progressing with quarter-over-quarter Our are good growth.

I we've more embedded reduced, done emerging. has our culture. base cost significantly has acquisitions been strong approach The are been a have late-stage received already we been in I well spending, value-for-money value. think, have importantly, and pipeline but think to And a date Our to creating

So if LEQEMBI. let's we turn first the talking start about launches, to

benefits although continues started to had got the continued from collaboration extent to the new to in U.S. the And expectations base the U.S. grew the uptake outside of our our is continues the as September. the an revenue of force, and quarter in expanded the from really sales who still in seeing and in to growth anticipated. and in prescriber The quarter. that compared LEQEMBI commercial Now be not of refine by XX% Global revenue the the below collaboration prescriber we've increase second third strategy, we are first field nearly we there U.S. out XX%

our potentially business. opportunities accelerate continue And to evaluate we to

revenue nearly where seem from single payer a Now we've by who activating the And some continued and absorb encouraged been patient we're treating expand We've networks their high-population help terrific enabled of that And in like to infusion think more been also and extend the are systems health Japan, and sites demand. extending starting in I U.S. care doubled see kind see to Japan there's large U.S., to does rate activities geographies in recently, system treatment It previous the outside particular, uptake China. the of has including quarter. growth. launch

induction availability maintenance diagnostics. and of of utilization soon over quarter-on-quarter near are the IV And widespread there We and we the that next for year, potential uptake, more could expect believe potential few future continued for a sequential as accelerate blood-based including LEQEMBI term. overall, maintenance as growth subcutaneous a catalysts formulation eventually

much physicians. lift for of Just a to is underline how this

Polson Catherine time Jeff October dated advances. noted the may University TAS have of [ written in about you They XX, an unprecedented JAMA Neurology, piece by [ talk Forrester ] Burns Brent ]. of Kansas and UCSF, at of of that at opinion Some was

But and equitable challenge health advances cannot at equally, of into they say a system to the treatment care is equitably care in and Innovation and manner policy timely in be practice overemphasized. advances the scale. the necessary levels translating importance scientific clinic at and translate diagnostics,

to we just market. have to we It actually to that we this taking number of treating believe system So going patients. important the issue. again, believe to an health continue demand is that this be is a care But don't time adapt

SKYCLARYS. paid both demand is from now as globally in broadened SKYCLARYS includes in EU, increased and the particularly Europe. markets We the where increased U.S. we to saw countries XX demand a are Turning This other mechanisms commercial in revenue number generating seeing we quarter-over-quarter. our outside footprint, of

rate are early point, we at between like In demand place. in rising is out patients. and of there we develop there Now this in programs the we number the say commercializing revenue I'd Europe. a to Europe, we the generate actually difference find the how a how access U.S. product. seeing we're our is U.S., revenue at And already in have In

the already population for those to on at have go while patients point, governments the reimbursement. a negotiating an board ready and on to lot is then immediate But are of you're Europe they with patients some treatment. governments patients get reimburse And strategy of products in because to get you

that at it's expectations. progression governments. quarter-on-quarter, we in a do tell a looking patients be I that a at adding in be pace the time you're every week reimbursement get our of But day, exceeded are point we of what can for has but the you Europe demand, reflection reflection every when ex-U.S. So not piece going is to to growing at going

now globally. access XX to more patients, and that been we regulatory are expand there Now to looking are submitted filings have

the and in third in revenue and XX% second where this revenue So that's expectations as in quarter, year. we're by commercially to quarter. part looking increase quarter, continues and start now increase outperform over driven we ZURZUVAE a patients generating beyond XX% million as the the U.S. they the soon an Europe, $XX in next could our saw U.S. of of

all I talking everybody outstanding markets. done pre-existing ZURZUVAE. not these the has launch. we've think about, that are remind this of and cases In LEQEMBI, with just I'd SKYCLARYS the been team an job

We these markets case. in are each building

And in takes pre-existing that you just looking go market and always you market. a where having to innovation incremental from are than longer take some share

we change the could if So slide, Steve.

pipeline X And to to is goal will sustainable to take to growth. that for One came even for a Our success growth can put objectives. had sustainable When is Biogen major in for this leaders really that revenue I the well back XXXXs there's medium-term build into company, of more and pipeline who company a build short growth. the Biogen really the sustain the I to and a onto pattern XXXXs. growth also term

really interesting whether products unlike we we products good do we with are Biogen, emerging. go think I work. have don't the Biogen. as past We that going I because really Again, don't look lot into the about we there innovation. some So to very where But know about think a to we say, see very I in Phase we at they're feel of are we pipeline, are what III, incremental and excited

in these biomarkers, we growing I lot have think in in indications we've a assets. seen and that data conviction awful an other suggest

an Priya of downstream. the a on existing protocol And were and we that worked this to XX and this someone recruited as I product space intrathecal go. dapirolizumab, we [indiscernible] Priya for commercial had because thought recruiting augurs recruiting. years, well will experience excites it's over therapies, where me to to finished early one So Phase already ready as Priya clinical and a particularly Phase that there's is and a one. things congratulate trial the III about with results, say, that like who's UCB is when had they're competitive me, although see actually saw positive in this III I'd early,

starting be very Phase III And so soon. we'll

and we've huge unmet actually Lupus and pipeline we We we status is have, game to not compelling. here, changer guarantees we products This lupus Diego at San also is iGen, behind breakthrough big In only look nephritis. encouraging there could in no data very felzartamab but But are our that And area indications. make Phase dapi, and we terms data in that have reason AMR. at have to of come had II had an development. market litifilimab have I that in because, think, we a least that, know very for X pipeline felza, need, again, a got on these some all in and us we've believe of difference.

it But the cumulatively the $XX real start we each of is about these of is today actually as transform at these, billion. about all they you late-stage got products, approved, I cumulative And to be of revenue have pharma could for to over market about and this business of And expert sales peak if talking consider term. the pipeline all made shouldn't Biogen peak The pipeline. really our that really billion, when $X.X Priya. longer look

I'm that, with it turn going to So over Dr. to Singhal.

Chris. you, Thank

on eye the transforming pipeline, as with we noted, heavily have Over towards medicines. and focused novel augmenting our years, X into last an Chris innovation impactful

both value to and in litifilimab diseases, Felzartamab As a multiple encouraging result, tau BIIBXXX immune-mediated deliver both clinical pipeline have SLE, supported in CLE. ASO meaningful has our dapi programs by as and that patients. SLE includes suggested. Chris several potential current data are I the believe Alzheimer's, to in in This anti-

priority. top our remains programs these advancing While

working now where Phase example execution. We strategy important the are a completed to to implement design decision-making amended An expedite expect this on to readout acceleration is portfolio we of and recently also in continuing broader the XXXX. in enrollment across trial focus II while BIIBXXX,

SLE our UCB, a results positive the this study in are quickly partner, dapi to moving with very for Additionally, year. III Phase with month, second initiate last Phase III we collaboration

implementing efforts evaluate continuing We clinical believe times. are optimize on the clinical includes participation help laid opportunities have and development development enhance a our of the to several working are we out cycle also This for and like external clinical has with Chris using development meaningful opportunity across In that that parallel these through we AI to indications. stage and to strategies to with and also and we to build aligned accelerate objectives, research innovation site corporate innovative pipeline, execute trial selection. ambition opportunity these to execution our the colleagues initiatives Biogen. Overall, new

we we long-term generating and begin are for quarter. effect as storing are options. presented to pursue the that in and blocks, we to importantly, data with treatment includes LEQEMBI by to showing real-world maintenance continue of areas with beyond insights benefit to Turning like where continued CTAD, removal provide Alzheimer's, continue to important evidence, would optionality working This just but early the with such also at AD. working Encouraged expanded on patients. Eisai treatment LEQEMBI I like

subcutaneous the and expect next XXXX. We IV auto-injector maintenance on both regulatory dosing for year decisions in the

Furthermore, the to enrollment in AHEAD the Alzheimer's October. X, X, evaluating just I look month to forward presymptomatic trial preclinical of prevent us enrolled well, LEQEMBI delay and AD or in advances. ability completed X study, this as or updates providing we this

working and targets also shuttles expand novel to treatment approaches, such are BIIBXXX. ] as leadership across states We with by including disease staff our different advancing [

we building a that range of in while our Moving proof this action AMR, relevant. programs where to and we to may continuing believe significant This established We comprised Phase by These acquisition be industry-leading PMN where indications are felzartamab, next of of immune-mediated pipeline diseases of characterized with cover an III concept. are unmet expect immunology. recent includes other year need. late-stage X programs to studies evaluate mechanism of initiate IgAN

negative multiple to where associated worldwide toxicities, and current it are various we X treatment-related that leading affected programs and also is after and women therapies. in of to limited individuals SLE SLE the contraindications suboptimal as standard over consequences most due aged U.S. million and are are treatment have of estimated options before, with lasting efficacy concerns in care damage. pregnancy during is common for organ death such the to XX Additionally, in for cause #X XX and safety

a III by BICLA are statistically potential significant the plus assessed the pleased the of in Phase greater report primary met endpoint plus versus of improvement endpoint, placebo at we to activity as study that showing weeks dapi care. disease standard of the standard pipeline, of care our XX Underscoring immunology

endpoints of the Importantly, and assessing that on we flare for SLE. also activity key prevention to key goals secondary saw clinical represent disease management treatment areas improvements

biologic had understanding our active study criteria II included along Phase Biogen, the disease need design and underlying the and standard spent therapy patients with biology III an attempt with collaboration III design top the a treatment UCB, a analyzing of time care. prior a Phase derisk the potential of of in learnings, to These in effect. results disease partner, on study inform updated Phase combined our ensure the Following of to screening of which demonstrate study,

by III of breaker a last dapi that approach to this is month the presenting years. a from study year. this Phase late results to in punctuated ACR molecule success is UCB, and The together Phase second at third results detailed with next forward over Phase show the the the fact study in We study as annual look this the SLE positive meeting XX III to only global expect III initiate

Turning to SMA.

more this priority has pleased evaluating [ every X XX-milligram higher-dose continuing the The always delivers This drug World earlier the the consists the entire X-month been month. from regimen loading dose regimen. DEVOTE nusinersen to phase of than to of Our ] administration of patients. results study dose the XX doses approved at loading for the were in present doses outcomes higher followed Muscle first on maintenance SPINRAZA high detailed regimen months. improve regimen meeting investigational by We Society milligrams of XXX-milligram

the more the nusinersen, loading The onset to baseline of improvement. with faster sham Part pivotal in SPINRAZA met the months than and in at objective X significant from primary Consistent as to change demonstrating rapid measured neurofilament DEVOTE, an XX compared the clinically infantile CHOP of by regimen, statistically B group, endpoint XX, biomarker. prespecified slowed day milligrams neurodegeneration cohort a INTEND higher-dose match

in trends both sham and permanent of observed the approved ventilation currently also risk regimen. We control versus or death reduced

higher with are results participants treatment. group nearly results to of improvement X exciting after portion the X in This initial transitioning disease-modifying we shared SPINRAZA XX, as transitioning on average patients currently therapies. from aged C XX help we of to milligrams the on addition, study dose. function Part open-label In motor seek an years These from to showed after

of the regimen XX-milligram in year. remaining to need SMA, dose showed We was submit and regulatory tolerated regimen. with individuals to safety approved these this filings the potential later profile SPINRAZA Importantly, a to results help high highlight address well believe the and generally similar unique aim we unmet global

therapies In conclusion, of meaningful and highlight to milestones important this pipeline continue that deliver development past new quarter, to to our we well several I patients. the execute believe potential achieved

China, we QALSODY In addition SKYCLARYS U.S. to late-stage PPD in Switzerland zuran ex [ submitted readouts SMA, alone in lupus ] obtained filings and and and also for and for and respectively. approvals

Alzheimer's, multiple across presented neuromuscular at data disease. multiple new areas, also We insights disease and renal medical meetings, including

well we believe to positioned pivotal is Today, the potential cadence launches. a that of deliver and regular pipeline readouts

and growth. deliver We continue to Biogen's for aspire our to Alzheimer's, leadership achieving to established as position bring transformative medicines disease to patients' that us objective rare capabilities lives while like sustainable uniquely enabled us on current our expertise that disease to augment in to reshape external core the we believe area look deep evaluate we foothold pipeline I and immunology Furthermore, opportunities areas innovation also same of pipeline. and

update. for over financial a With I to now Mike hand that, call the would like to

and hear me and to comparisons XXXX, some like results all morning quarter are the third me Priya, to the you, versus provide that our note on third of color good you'll quarter Thank you unless I'd hear make otherwise. everyone.

the for we moment, income billion. operating some to quarter third and were revenue the pharmaceutical dynamics was prioritization and total Total down from our initiatives. that's Non-GAAP additional continue key from Growth quarter some revenue increased just Non-GAAP down and to Fit the on XXXX quarter. third In diluted provide for note a $X.X core versus R&D EPS of X% as benefit X%. Both detail was I'll X%. $X.XX revenue

raised range a year in We be range. additional to just full XXXX. some on again I'll are guidance color few moments, for pleased provide our And guidance our XXXX raising

Few quarter. for third the comments revenue on

product Our that dynamics the primarily revenue approximately dynamics. by some driven by and with channel along X%, MS competitive was declined in space,

Patent Importantly, of announced the expires dosing, we related Biogen's covering the of European last week February DMF patent validity XXXX. upheld that which in Office TECFIDERA

decision. are with the We pleased

anticipate do and this patent, challenging However, generics challenges. are we further

a to in is a the although competition launched in TYSABRI U.S., biosimilar impacts see continue high-efficacy has not from yet in class. biosimilar seen increasing the and Europe, we entrant

growth million, X% generating progress revenue by increased the revenue offset driven and revenue pricing U.S. SKYCLARYS second $XX by produced XX U.S., third newly revenue in that franchise SKYCLARYS global was from in continues some of quarter an quarter, the with partially up and that demand, now the countries $XXX disease of dynamics million. reimbursement XX%. of rare second where outside our quarter, was in This The and was $XXX that driven increased from is to the and markets. demand. by Next, launched some modestly in launch represents of million increase

affected of revenue once impact timing decrease year. QX in impacted quarter. the unfavorable but loss the in approximately SPINRAZA XXXX impacted revenue was here. expect by to by revenue that third of $XXX further to only Russia, X% which currency. not million XX% to is of tender It million, rest an revenue an we each U.S. global was the and or encouraged contributes the remain was foreign and SPINRAZA we up in some annual for also tender performance million $XX year that impact of The this and do resulted Global results, shipments $XX million the important $XXX by and declined note which of this occurs

contract finally, completion and year-over-year as other was growth million, quarter. delivered U.S. million. demand. to certain $XX in and that's was batch royalty for in-market an expected in-market sequential continue $XX XX% second million third to That global that's due That's the be manufacturing, second up with million. approximately booked the of quarter and ZURZUVAE of LEQEMBI XXXX. XX% in again notably of up commitments sales increase by in And $XX quarter. by quarter, were in the encouraged $XXX revenue We the quarter, we the from Eisai the versus XX% revenue second lower sales up versus LEQEMBI and saw

Fit on cost allowed quarter R&D in driven Non-GAAP costs as the revenue Non-GAAP mix, X idle incremental particularly and product by of of from sales as revenue continue million as a charges. the in for a increased points, primarily well and quarter in SG&A percentage most contract expense decrease our revenue of to I'll as increase million product Now as decreased benefits turn was capacity Growth expenses. lower manufacturing that year-over-year of X% few with launches. third third comments we launches the from percentage $XX initiative the from R&D decreased our third the quarter in see absorb to prioritization our initiatives. Non-GAAP $XX expense us associated to benefits new

$XX garner by continue billion We of of certain the quarter. third initiative Non-GAAP we and of unfavorably $X of $X.XX income. income of in was $XX which XXXX. approximately items with result partially including interest million the savings in net for the $XXX net added items, offset Fit HI-Bio-acquisitions. lower to million associated some the million Reata quarter, a by cash tax favorable EPS of to decline Growth balances can about gross impacted EPS believe our our net nonoperating a and as by was was on end This

that cash marketable were update free billion ended our able approximately flow since generate brief approximately $X.X cash highest the million flow, $X.X $XXX We of the cash and was quarter on with We securities second XXXX. a Now quarter billion debt. of free and our of net of to sheet. and balance

from in capital flow cash benefited quarter working some Third dynamics. favorable free part XXXX

opportunities. us both We and invest external continue that provides to growth in capacity to sheet balance continue and to remains believe internal our strong the

reflects highlight of to this at midpoint full $XX.XX. This range and XXXX. new between raising again guidance. of a performance the full key non-GAAP I'd between $XX.XX the year Turning the $XX.XX to year-to-date, a guidance EPS few year growth the approximately diluted of pleased of to new from range range business to expected range now to and compared relevant XX% XXXX We're $XX.XX assumptions that guidance. supports our like

decline we revenue top First, will low line, our a by that the percentage. to on continue expect single-digit total

in which our of the to behind important And includes to fourth seasonally on to key as year, refer spend would year. I our as in our areas be we've slide and the help product HI-Bio. as rest ramp our following well will key And remain believe case long-term the expect investment the In to throughout with continues late-stage is our of release assumptions. which acquisition lastly, ongoing expect launches Biogen position focused growth, higher closing, sustainable #X guidance our continue pipeline. product new efforts areas of our quarter to compared SG&A communicated these you this goal. and other we for as advancing as We business, press the felzartamab launches typically R&D we we for our programs

And the with that, for we will call open up questions.

first Brian the with Abrahams Your question Markets. Capital Instructions] RBC of [Operator comes from line

LEQEMBI, see of your I'm the potential when in you're as you October. characterize days in overall more to expanded the remarks. starting your might efforts, prepared on well little from curious strategies with signals on commercial commercial those whether any plans. other that expect commercial pull-through you and to a mentioned more on for see you alignment maybe Can the some expand bit acceleration And

pass color field of I'll then the expanded little second over can force. Brian, and take the on it a give Yes. the Alisha more to question, part

an around lot since product the things we launched PET really also team we learned the we launch year awful commercial we needed fall, I last have like the mean clarity of really all to place, really get the in the I think but I reimbursement had started of mean, scans. product. in

of about this really So I launch. for us, is the think the anniversary

there But are also lot time understanding for their that a the number IDNs now are place we get and in the of take can care there it of protocols And to really a sometime are things the who's have data we more maintenance to next maintenance, going year formulation, awful for And the patient? coming also IV like right subcutaneous lot an We're the for hopefully, things have year. next along. pathways.

we what's give probably able what X you So could we'd to on some to the that. working doing seems together and well it now be more so just be for review color partners opportune more? And and come

working this very are well teams the say a would very launch. together. We both understand is complicated I that

have more to most as think, high awful work patient, seen, make PET really are seen. happen patients who's than complicated percentage the of coming again, lot of physicians, see this yet, do people I an And we think I putting most a that lot certainly all I've of who in eligible really are Then a to not right and of organizing the into neurologists the patients the MRIs to beds. punctures, scans infusion triage the treatment. are the the lumbar for

So lot we've sales week. of every effort out prescribers and add and seen see real awful we week the an we marketplace, every there in more

think And progress subcutaneous it's so I that's get going the for we the until induction. way to probably

again, that a might could and of I the maybe about reduce think, anything think think dramatically field be of helpful. the would, PET Both be use I blood-based diagnostics you you force workload game expanded place of changer the those physicians. quite in But else more and Alisha, scan. of talk can the

what have we've seen the increased QX. did in actually prescribers writing QX, the the is you quarters. of number we able launch don't number versus new patients including see And of as XX% in see encouraging all in also prior steady As the seen that progress total in in to QX trends and you have we're by new of that's writers

physicians come these are week well. you seeing IDNs every single week, as expanding on single every So

in while, key infrastructure field in launch the after up a these still However, at the today, been to. forward the even challenges, is barrier out shows what we've for research fast the just and Chris market alluded end of is of the beginning the in as day, like

to written that their concerns. the now team especially of However, who with that, physicians really new haven't is X with on Biogen able yet, we're main confirm Board, also

is of course, of a big ], second still [ area though as as it not was it's Our concern, even prior. concern

you they some alleviate. work they once their patients that and protocols, out through see do work However,

of applicants over that we little And luxury who a a XX a situation only little now and posted we we full have out posted. organization in had at over as were We an the as as these roles reminder, field When we a we to roles, had However, force were intentional very bit had our hire. there. time. X,XXX we to

those really and history able in disease a to we were territories already pick these had had in built in history So or relationships. who individuals Alzheimer's either

And there so for weeks. several now the teams have been out

are bit do are see where starting little We overlaid we more has do the rest more of representatives also, opening we Eisai. are nation, we're little physicians. the prior Biogen than targets offices those us reach a able up engaging, see specifically accelerated did for with relationships you growth a to Where again, to easily have doors more in because, see with what and in the

rep day, actually And with depth. for the to Pacific say MS at a away. years, in the example, with end to XX had that's prior able the relationship the are for longer right that they're term, continue had we going we in a of physician obviously so been doing frequency But can in help the Northwest, we

they Another less over over to XX a patients, unlock were physician than in in the had able time XX a relationship X-week period. years. Southeast think, They I

and are even we month or starting they've though acceleration, seen So out mattered, about has the been relationships only we've to some see there Also the for history so. mattered. a has fully

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

Chris, times filings us the on a you the maintenance formulation status the you've of induction? of for well referenced subcutaneous Could update morning. already this an more for of couple both as bit as a give subcu

over Sure. Priya. that I'll turn to

our really and to then expect to moving that has as filing subcutaneous we the be complete indicated, Eisai to remain on on we So maintenance imminent. And top initiation.

on has Clarity initiation part We calendar regulatory data. Eisai This open-label And of as are the indicated, working the extension subcutaneous to a generate study. outcome data, analyze on by therapy is expect QX to of XXXX sub-study. track subcutaneous the in we the year. remain

Leerink. question comes next with Marc Your from Goodman

more the dynamics. there little you us opening remarks in a to challenges. a on pricing about the And give a comment more was and comment reimbursement you color Could bit There little SKYCLARYS. if could just

negotiate doing to treatment. to revenue in you you we're the what know, we as actual already reimbursement. of you country varies are have approval patients and patients then by those for Europe, physicians, seeing So But but country. getting go on by is get And basically, country generation

are you you than some for there for where can an program. some you countries, There countries charge there much where can European countries. other reimbursement instance, earlier So are can't, early where countries access get are

So process. we that in are

have -- done started has really patient we generation the generation with not revenue What demand reimbursement. the sorry,

active up patients. and all in are We countries signing

see considerably demand that those is so by revenue-generating numbers, of the tracking convert to lumpy will definition, in in a generate month. actually is to patients. patients And quarterly numbers growing we when every patient revenue. is, when What advance you we're are because little going which the patient be revenue And

where if can can have pay the most we that's have those on make just programs normal to a in have And establish price. price -- on we early process is had for obviously, revenue go than there and is, what and charging. in programs you adjustments in really price to as into that access the launches for, an that some going idea And But cases, lower to charge the you clawback countries be on a where Europe. a booked we've prices a point the you're those is have you reimbursed we better And some where EAP.

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

development. you've fourth? as for regard the R&D, Chris, the on to Any the latter the the but thoughts business also efforts with lever to you in updated to strategy regard to late-stage noted spoke the with pipeline here

horizon, competition. extremely our X assets industry we've you I those do we're across and pipeline the And how that. in is bridge see that of had situations where portfolio a mean legacy in facing we an of promising increased classic on

some the likely is of business I would And choose to wait the for pipeline. and arrival grow that the out and growth now satisfactory us. our simply And wait that necessarily companies for XXXX, to not between say is but

could that enhance So of we to near quite in create Are spent also assets continue the could we term and there this. I for time are value on bring a but our revenue still looking lot shareholders. in personally that look, growth that

pretty can make a they market. we we then as return revenue. buy priced the very assets so. buying We're interested you on and But good not get know, can to get investment, just really close we'll highly in as do If growth,

lot awful So an looking, are you lot doing. awful of what and do digging an and have that's we of to

somebody private that disciplined both of else's considerable get may active in I people we I've always want companies. make shareholder think capacity. are financial we comment also not said we public And shareholders paid a are money. look whole but fiduciaries we still to of have have and shareholders. at our And We that. team Mike, wealthy, you But that, on to

Yes.

of on structure, in with just rate run about a Salveen, our debt cash just EBITDA billion. ended an capital reference. billion when about the you about And We capacity, give quarter you on $X.X of $X.X to billion So about frame to on $X.X think of billion hand. total $X.X

quarter. it's in million a So about that's think Xx we're free the you year-to-date, about flow billion $XXX below capacity, modest with pleased when gross, cash very $X of And amount.

plus you billion in there's amount over and dollars less things cash you to if the of $XX comfortably of billion added that X you've other supplement in of look the $X year couple leverage, years, couple cash than a the do and help point and next flow that transact capacity on of and year or billion can reasonable we growth. at acquisitions of next hand, and gross to our order got can to over X with see debt free per collaborate free turns a at some the incremental cash of plus So time flow

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

the that interim enrollment just study. that, line would understanding time potential more if there positive? an We pretty look would be specifically, based handle are noticed the for why And completed the remind And Is could be Patients. to I an ask be is what analysis population? early expecting that [indiscernible] would us this AHEAD a you of on? My there the Priya,if enrichment these is that X-XX wanted for of what you you that can

Yes, excited X-XX completed Thank you, Michael. enrollment has in that the we're October. fact about AHEAD

and higher stages, of early with other is looking trials, and with at everyone, X amyloid trials. early Just very are it's load these large intermediate and intermediate to is amyloid remind X patients really the stages

in the which point. time patients a is X the X, about X,XXX the AHEAD stage XXX AHEAD X, and earliest XXX-week about trials intermediate patients time have the So it's and in line,

regulators ready are when all be of out. to look read we said parallel with in options to that, Having might continuing engage and at these

we'll and or So continue early clinical improvement. with but tau, a with in patients about of data benefits the low excited you and of treating to lot specifically provide we're that that shared terms from Clarity study very even no the tau really, more updates, stabilization having completed actually shows because see we've enrollment,

it So very today. and very a to why excited exciting be space therapies, have continues we to about patients are for where that's we're really

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

on focus I as there's for possibly quick I'd very like And amount slightly of I different going second. molecule your does your as look BDCA broader a as into It and is question lupus significant between well. well topic a felzartamab, investment R&D the thought CDXX my this. a guess

good a might obviously Phase in CDXX news. from But manifest data we're CAR-Ts, which III, You some bispecifics separately, which possibly remission seeing CDXX even as well. is hit some incredible

T get should emerging So CDXX lot to not we exposure, CDXX the I of relative like bispecific. guys And how on potentially from you have the you is guess, area, or this engagers? time some weigh it a which do bispecific to cell seems market of by that the data

in more when the think in here, very population. watch in But the it's shared be data the you think we've innovation seen few step patients. back we the it the to Yes, continue moderate-to-severe ACR and what space, about a with weeks can this you exciting we'll is and sharing and and excited embargoed, at we're for data by And I offer. we potential, that dapi

So believe will just really high be of And is very population. stepping global options heterogeneous, many back, and it underserved you chronic specifically disease, women in that burden at required. we when SLE, disease, look a

not CAR-Ts is sets here that generate of and B inhibiting while data And looking to where in I relevant us data success small probability with after of interferon may small high Phase show in the III in and to T that inhibiting mind entire Phase believe the bispecifics may makes and and sort the a think hypothesis the the litifilimab, really have in efficacy with the I type becomes really the important. these So X likely dapi, that population, signature to and at could the plasma keep CDXX population. scientific are we've and be we're continuing think interferon very activation, And addressing that then to II we're reduce And itself. downregulating BDCAX really we ligand, pathways. in cell going which delta has got ability

So far many we that be but really probably trials. going data momentum really that and to required, have are remain the this about optimistic with believe seen that we is options the and we our important we've so

So be and pathways also we litifilimab, we're know, been continue XX as cutaneous there believers really these in these no you has to With slopes innovation programs. in addressing years. where

these. we'll mentioned, conviction, scientific prosecute Chris continue So as high again, and to we have

that because years when was modest I'll to has only the we we lot program be have And over efficacy small until seen years, were X was said. And over else add, of third. and was last killed would almost failing, we of data just populations I And in date, as tell at we've and the product this realize the products approved. Umer, you, standing. Priya can XX ago, been BENLYSTA awful everything I GSK developing that Dapi an

And who gets the to finish see wait think have so actually to line. I and we

On CAR-T, going seeing not some numbers personal of are treated interesting such CAR-T in significant you're logistics patients the of being be opinion. that to data, my but yet

a as So need there there's I said, Priya think today.

results you're find this different take full going the X any just It's demonstrated that speed We going product of not going And have given I think approaches. going disease, winner. ahead. to to is we're a that ultimately be nature there's product that a has to

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

the quarter. nearest term? from which you the your are Congrats X peak $XX relative the X in key contribution pipeline largest the ones curious programs. products We're talk of about on Can terms of and billion of the about and timing potential revenue

forecast. get into to don't want giving individual revenue I Well,

of I think be where the not programs. that succeed. going But the pipeline. if a look sense to you all always was to what's We the do there know think idea give of I are significant everything can at magnitude

and significantly. think see and to one. continue invest you at believe, is not Roche BIIBXXX Biogen If in look the Alzheimer's, I only ] do we Lilly I [

for You've early-stage in out money very awful Alzheimer's. lot seen of AbbVie lay a quite an asset

system adapt demand is think for I significant market. becomes able believe we health the as this that care to the So all that treatment important to ultimately an

Alzheimer's, way not was we there spent just major world-class I significant at all said about believe And week, severity people after field and really varies a have seen benefit believe people really what a they in of tau that with in we of at see, lot the are medical excited last will really researchers and the a a tau can Alzheimer's tau beta. level really school for have lot a a day that a we of in with going patients.

amount we also And dapi, and that tremendous also in have think certainly as litifilimab is a nephritis. lupus So we with have do BIIBXXX product potential. said, but of we a Priya felza

selling do as see a again, at look in, indications a all look you X where significant see those of for So have hasn't be felza, and is this you a we market we but And to And market. billion expansion. then going opportunity. about we being going patients III X numbers AstraZeneca that there's at considerable a at as year. done an is $X look there's Phase of significant that room the BENLYSTA In still at is programs product lupus you well, that

wait we're teams to XX our you what is So trial up. of data the the like clinical potential look you is again, Again, between number, excited have kind at potential emerging see But what X and and somewhere if of and looks these XX need profile. like and for have increasingly add the markets we them about top pipeline. but this becoming in estimated. the the actual differentiation, unmet the

Markets. of comes with line Capital Seigerman Evan Your BMO from the next question

to talked we've SPINRAZA past, the in for the about potential know I returning growth.

this numbers accelerate the reaccelerate on can and softer there quarter, pull Is other you how achieved. think you nusinersen? just predicated high-dose you Or talk this are factors product? to of that growth -- the can that Given this is levers it about

And that intrathecal treated. Well, compete therapy on. so exceptional SPINRAZA globally, of an limitations ex example, European effects or markets, even on it efficacy the but be -- oral turns of we clearly actually, that in growth benefit ex is really we diseases. gene a that of competitive demonstrated, the out actually, out have can if And -- we what administration, what that of SPINRAZA. matters some a in the we [ and the SOLgENsmA to though onetime see as marketplace. U.S., effects sort It's the adding very we take for of ] for of a We had know study severe has really that's which patients have terms therapies did

for and intrathecal get to loading get number the that at through level faster think phase. the the is the believe actually reduces teams because we And could we of of I injections previously. -- loading DEVOTE our can important therapeutic right that extremely benefit that doses than the least to

efficacy is U.S. perspective. think you ask I at see least but really this from I'll a Alisha, that? an How So gain,

SPINRAZA business. has a really very strong in contributor, been especially the U.S.

SPINRAZA that a then and benchmark down like when patient. efficacy has for you excellent set to believe we So look what disease, it looks rare at really translates really that

during a team very obviously We we and growth growth switchback. is a the of efficacy our of a oral leading has and product One, orders really very during And that's had the so also year-over-year, from time for with few do way is SPINRAZA. comes lot believe it's reasons. which still And launch team strong. X competitors. seen, And my had even we've stay-at-home the strong the

isn't maybe There's back that returning to a SPINRAZA a efficacy of lot are they've there. realize that away to they competitor, the switched patients and once

in forward see do space, secondly, we in companies with that's new this years, into this a quite still bit major of biopharma you fast so putting rare U.S. and disease. money And are that finding patients X And X the we

them least believe we are see do at you coming good And quite patient side, to so quickly. new online. And we still very We're on at able finding. patients find the Biogen

We we of sort have use with AI that the an along field force. machine excellent

We're in physicians of find able excellence able locate are patients. to reach these them and centers and to out

you X coming feedback And the dose get and so from pieces of physicians of high patients. do with

just As more. had we we you know, wish

least approval with growth so right the we're support the quarter-over-quarter, going also filing And and now label, U.S. high that, do for year-on-year and at we potential into for preparing that, will the organization. that obviously, dose believe

Your next question comes from with Paul the of Matteis line Stifel.

of way legacy any the dots forward? do you've bolstering hires experience have as be spot portfolio appetite assets connecting do certain like more Is sweet the around some you it feels its when high-risk areas historically at from development, that a to look you words, going we take in going immunology, rare lot feel neurology. neuroscience? made away Chris, you the of and are have business here, In going risk and you in to that Or things in relates is should about to and think forward? more shifting In with Biogen on your the like it decisions more some of right maybe expertise neurology other

programs every millions first, very programs We're of brain in spending significant in that of say, would we Denali. a MS program still mean Alzheimer's, on of Parkinson's have I shuttle year long and in program we're the early-stage And I in obviously, BIIBXXX with we LEQEMBI. on already development. we earlier-stage at number coming R&D. working ALS, We're in a with continued but partnership have neuroscience. significant behind the significant technology, neurology in investments, LEQEMBI actually other and hundreds still investment in dollars looking have modalities

area. think MS as to But immunology an franchise. neuroscience therapeutic it's I think be in have significant good So we somewhere actually is And in beyond think really just we already the where commitment. whole see idea I to a capabilities have already I addition, franchise we neuroscience a me, not X

acquisition. awful biotech the of and I&I, a conferences. gave we us HI-Bio I confidence lot You And to the treat I that do venture an of believe certainly the system. go have MS conferences do number and through to immune immunology capability

in I&I has area after now second most R&D become oncology. the important

products, so lot has capability scientific lot one, small that of disease cell. do of in is model tremendous going really does. and a awful of that opportunities Biogen build. diseases to you're immunology differentiated high-value I commercial emerging rare fits highly we Rare in an more that a have And an capability BD a than has not this And description think a space. volumes for but commercial in everybody awful scientific have

being, area go. say, that would into that agnostic with expanding area commercial an indication can model we that so And I is almost

shifting some our to from And some And to the I focus traditional focus being Growth we some able capabilities. heavy in MS ways, build. that don't think we're There away and are stretching on Fit much of really was for to of these have as capabilities. a capabilities don't incremental adopt innovation some the in really against But companies pharma not really get we'd want into Biogen. up other -- we in I where into to model. wouldn't those have areas commercial go large We're

probably of really the a a we like can diseases within of that have take legitimacy in certain really comfortable we smart to But capability and we we dermatitis. people have play and atopic advantage pretty to lot there, areas or and rare feel related neurological immunology, Biogen. not the RA I can more things horizons immunology, conditions in expand necessarily So our of

comes of Morgan Terence line Flynn Stanley. question from Your next the with

think directionally for XXXX puts takes. wondering and Mike, about and help margins I can was you if just of the some us

we've of was operating going good our primarily quarter. third revenue probably SKYCLARYS. seen. really higher bit was the revenue like some what But you've we Sure. to and that margin. bit I the you're progress. improvement dynamics lumpiness and think it's driven little to in about a The less of income referring It little -- SPINRAZA, I'm There's made than Terence, some it. that of assume, the And think a that And quarter talked I margin to by in the

feel income best percentage think it's year-to-date point should improvement, year the XX% garner year-to-date to X% about guiding and on the In up and margins. our mid-single-digit I remember improvement can the guidance, the confident as of continue savings high this we improvement XXXX XXXX, we've we're good a We're growth I year. $XXX And we for for say, it half we the important the the expected think which talk and about full operating that our And other into billion line, X if basis, by and it's million will We help that we've to $X still way. head year-on-year. full teens next I growth year, that $XXX to exit gross said on that half But we a but that's feel we that beyond at you the look year of not made. end that savings, of million think year. probably get I this net

go. So as that will continue to profile our improve margin we

you, you, today. us joining for everyone, Thank thank Mike, and

Thank questions. additional answer you. Of any course, will be the IR available team to

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

You disconnect. may now