BIIB - Earnings call transcript Q1 2024

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 First 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 Mr. I Head of Triano, Investor Chuck Relations. Mr. begin your may you Triano, conference.

Charles Triano

earnings Good evening, to XXXX everyone, Jennifer. and Thanks, morning, welcome Biogen's good first afternoon, good call. quarter

section you will that we financial including in discuss non-GAAP to today, GAAP our financial I'll reconciliation Investors Before measures, the GAAP the are tables, with begin, of financial the release and earnings measures biogen.com. related remind and that the we

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

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

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

today's Chris, we possible, yourself And allow as us to that Alisha make some through move session. Q&A Priya many is will X opening ask will our available CFO, Chief McDonnell; Viehbacher; for Dr. Officer, questions to Chris Alaimo; of session. Head and Q&A each you President President Head we'll and to America, Mike Mike I'm by and On the Executive our comments, and question. to our of and then and kindly with North joined as us Development, limit Singhal, call, Alisha the be get

to I'll way, of over out that now turn the the With Chris. call

Christopher Viehbacher

do, earnings got demonstrate but several growth And lot to per of per us share everybody. great clearly years is to still morning, that that's certainly work business the quarter. allowed it we're of in underlying the to Biogen corner feels a it achievement. like share major the the be first announce able We've performance Thank our to is time This turning growth. I you, the company. first Chuck. actually think Good earnings in has a in Well,

like to thank to opportunity colleagues. I'd actually take that, my with And the Biogen

instituted have patience And like the this them process. for I'd passion thank to change of commitment, company. lot within their an throughout We awful and

But in that I some numbers. think you're of that change occurred seeing has now the

and We have really putting focus tried things resources more do bring behind value. our discipline to good and lot a that drive those to

on. may awful see one of is that you there that And the is reinvestment of not things going an lot

to early save told of me, not career bosses we And business. that's what true. can't in once your One this my And you do. to is really out my way prosperity that set in absolutely

as which gross $X achieve The net and million is, in can XXXX. in as track $XXX of see $XXX Fit for billion you Growth increased million on by its to cash the of numbers, end savings, cost well, by and the from way, project, flow savings the

But what redesign to tried organization. do the we really was

first-in-class new as and on launches. hundreds X supporting really sure we're and we new in launches. going being is in behind Mike into margin more reductions fact, cost dollars go there that, in these detail, improvements despite invested the to and are but millions that of of business medicines, multiple our focused decades so sclerosis been are make franchise, have We we here to a needed launching And for those

decreased, and focus to this And us actually our most assets conviction. have where overall enabled in the investment expense development in we the has has while research increase those

exercise. been savings This cost a than has in degree. redesign, a more much and a culture to is change our this So a

if is everybody is that obviously, And can these slide. interested most the let's and LEQEMBI, at one to of some we So look in new move that launches.

we're first, a at this quarter-on-quarter look number seeing of different Obviously, can layers. really in trends. You good

X.X-fold where increased has drug we quarter. on the patients fourth finished of number compared the to seen, you've As

Our And in-market that's year. important. obviously versus of almost tripled revenue in QX last QX

lot I for is But how me, launches thing lost to is change decades, look at this important count the in extraordinarily this, amount this launch, business X.X But seen. not many really that. I've of is I've so that of difficult really the as an I've much been facing to that is becomes because first and just patient are and that are physicians with on I -- it getting really other an those even really to profound. to evident who as there And around are talk seeing doctors to doctors, this hospitals of awful challenges go treatment. that that talk

it nurse take were to major they to to be having X hospital, to it access X-year a difficulty through, one of lot navigate help approval the although And and plan clarity -- develop there all channel. a had at reimbursement, it going are around the months still the infusion the you just the was when beds. medical center, pulled to CMS get just had at able to them We business system. another took a was getting some actually to hire way that, look scan of PET a lot them uncertainty through And that of clarified

to these time time getting when it I'm at I that is, think getting these are investment lot and necessarily what for when not by of I And that. and reimbursed numbers lot credit, are challenges challenges, investing overcoming barriers. a there -- look their But those it's encouraged lot for a physicians, done. They're of a physicians, although really of and they're

disease seeing on need what so who, think, patient is this the day-by-day basis. by a I when loved people, is, accomplished look that the important. they dreaded from families, who are patients at that see pull They And away their and

And Alisha again, and linear, will overcoming to to an to are there's credit of that I these seeing in think think be But more with It comfortable we're lot has go have let's volume to awful patients awful to of you done to pull there takes centers once of patient, a So all think starting momentum then detail see may they've to an we neurologists even it then to tendency see do these through. quarter-on-quarter first us here. not time I get the lot and is the But And that. allow I into been the system. so these get going handful continue that, on we challenges. when growth. get And to a place. completely protocols

now not pull And And And I is about a seeing place quarter, more little once is demand interesting behind upfront look that we're linkage are linkage seeing a and ready, so this we processes between this, surrogate the -- in things think and And of other of revenue this that once first things one here, revenue you this are because actually that's one underlying for is those time that. there of the all it as through. that, clearly bit generally, demand an has is we're launch that taken clear see demand. physicians at quite in behind there's of before revenue.

I a us to think more. So of invest given lot has that now confidence

scan being a even U.S. Xst been this have cleared. could able hadn't plans. And weren't field XX% PET fully mode in because of our that until expansion didn't the September. I of say We force in then reimbursement to launch But you the really start argue launch we is would a also

work teams X we're launch. from at as months redeploying the But what's and for here to resources really, we the and look there Eisai now And first done lot at Biogen what's and our U.S. the of of not. both data awful some have see looking an important

progress of we elements a promotional our think the will together. number the through that of well new come as And quarter. I we teams have working start second to are play really mix into

from new the any Biogen occurred. that I in We're I'm patient encouraged think starts by at and has it's So increase the view, revenue. put going to But month-over-month point forecast. be certainly progress early to a those looking I would of say, too extremely out

gears we're analogs. markets. switch market and And is how detail, if investors disease. versus driver, go the progressing other and also again growth Because so always think which There's rare Alisha key population just behave typically catch-up SKYCLARYS, I show rare as other more in doesn't another to a into will I in disease could

work underlying takes at so look then a it catch-up through that system And the while population to the have a demand. what's and for

in build Remember that of and one And huge of strengths. Biogen's into think is patients there out I sitting finding what franchise. to me work are is to waiting that amount the that patients. there rooms gives rare a That's a know-how is a invest that's goes not one I actually think continue these And to think that I disease confidence reasons more, want we do Biogen. of the within because

remember, this treatment. January. the -- X,XXX on the -- a also was we've on Europe. approved I'm And only We've really and yet got end have But number. But significant we of really patients at That's got patients in XXX already already the by therapy launch in U.S. encouraged in drug now

to know to Europe, all country programs. have country You have and get reimbursement, we early we access by go

can Some of But those submitted of we them U.S. have dossiers in some in X for countries revenue reimbursement we charge can't. already we the

and increasingly add looking think also the revenue. the to if successful XXXX. the It's I XXXX more launch a of I'm to think acceptance story is then off in So Europe will at a I But probably uptake, that start. than

disease and in is really in was Remember, because you're And leader in European patients. we lot Argentina. a has actually went a in already and I to well. as I Latin of was example, follow in America, there that this is there patients that's just of no in Brazil, it And that a us basically explorers actually and awful descent. studies. interesting, genetic patients and done quite affects benefit going are who to where Germany to know genetic major opportunity be submitted going the that the where are you an submitting key we've people think find talking And And fact, for for Asia opinion

in bit I'll think Alisha. a I and deeper, with to turn dive over that, little it So let's

Alisha Alaimo

and Chris. you, North morning shared, Alisha to our lead the Thank Chuck in join to I'm today. business that's Alaimo, as I Good able call America. everyone

launches and share depression. really for growth. it's and with patients the with postpartum history access might thought us of to people our support This meaningful how first-in-class be a period unique to we're the which tailored dynamics opportunity an ataxia We living Biogen's multiple launches drug it perspective drive provide provide therapies. help a return to is seeking U.S., more a on And to to to helpful also the approach market gives Friedreich's Alzheimer's, in team, in our with our

me Let begin Alzheimer's with market. the

turning across Chris and a monitoring. the and page, treatment we to We phased mentioned, are country a approach, on extending the health get expanding seeing now their their systems are they with we up take they believe model. are meaning are diagnosis, where and many and focusing As pathways setting major deliberate, started seeing staged some patients dynamic IDNs are

we In quarter patient QX, X.Xx quarter XXX scale tripled saw our compared on quarter X, X in several units quarter increasing patients in X. therapy volume. regions Among to across overall X which the contributed to more their estimated versus IDNs than approximately IDNs, priority

acceleration really this in the emerge of end believe patients We new quarter. the to began at

more March. than added Today, an example, than LEQEMBI with XXX among since our order. [ of their XX% in were XX% placed For IDNs new have ]process, XX% more of through patients and launch nearly those have IDNs, P&T approved approval priority

treat to potential the still of We that we're helpful double we're the And volume seeing of X. it quarter IDNs. unique compared in in with the examples to LEQEMBI. patients level. priority saw might unlocking be these experience share of mentioned thought high X believe physicians at site number some We prescribers quarter early the also that gain to Chris the more at a I of phases dynamics

units. large X system months system year. that only LEQEMBI is XXX July of ordered to formulary its entering the health had QX, There in last added later, in Midwest X the

ordered However, had X,XXX by the end of units. March, they

more about entering to the system is this to X end formulary shared, ordered also to By X,XXX in just I than months LEQEMBI a that there in of units. XXX QX, their patients. system ordered example QX, August system treat units health later, its Southeast this the added 'XX. the Similar of

to neurologist region same patients. units processes that been period, a in more same the able treat they've network X,XXX local their through to time perhaps context, because For ordered scale

at of However, we of the beyond IDNs. this expand-and-extend the at locations, IDN site planning move trend example multiple to is flagship well-known is Southeast which treat to another their care believe

and commercial phase, We recent now be to mid believe continued we that staging just many systems the the appear to trends belief support our the opportunity represents term. over think completing longer a LEQEMBI observed significant

direct-to-patient Eisai. to time we to join field which accelerating, omnichannel focused team, already-diagnosed the With volume Eisai patient to leaders the this marketing Biogen programs launched right the of digital we campaigns. access and new and activate is working a community, also the field will These and on are are expand infrastructure are Biogen point-of-care under believe have and a who the neurologist. Simultaneously patient believe resources progressing care hire customer-facing and caregiver force. patients

With the forward these we more look promising emerging, providing in to signals future. updates

driving believe most market to rare as exceed Now strong analogs. performance the rates moving we to We continue of launch we're disease SKYCLARYS. penetration launch with

As of X,XXX over exceeds market have now the SPINRAZA have XX, U.S., our in X,XXX addressable launch. therapy, own patients we with strong April achieved estimated Friedreich's on we ataxia penetration, patients XX% an which

are patients or patients who believe suspected moving we have typical uneven, received are month. the numbers As Friedreich's may population now diagnosis Though additional to ataxia. to a catch-up anticipate is be with each launches, of we adding reach previously patient rare beyond disease the we

we drive soon all of progress the disease our reimbursement. now pharmacy long for logistics are as Notably, patient in how efforts support securing integrated have access quarter favorable These help shared on XX% remain our with in treatment as continued sophisticated to quarter, patient lives support. policies patients team and capabilities start U.S. critical to Last access of some we've to and and term. nearly market make X. improvements possible SKYCLARYS Today, access rare therapy

With in a foundation phase X patients of launch. key our on next are we on therapy, areas of meaningful this focusing

SKYCLARYS. PCPs Friedreich's and focus with And ataxia patients. our neurologists engaging second, appropriate additional and about HCPs. begin community I'll educating on First,

patients. a data can in potential their these physicians, patients we we community. AI physicians, the top and believe into anticipate the patients untreated a option. the With our care we we patients and Friedreich's when we patients using have HCPs if addition with of relevant treatment genetic centers field are of To insights may the are with reach also have believe we SKYCLARYS ataxia, confirm concentrated analyze and sites help to Remember, treated testing, more even And being at sooner. engage footprint with excellence, expanded to last can they diagnosis is in support who help determine to being

As patients as activation media. far patient that are sharing we encouraged by real-world social our are focus, experiences on

slowing Many cases, progression include SKYCLARYS these experience, about of help even an stories can in impact of diagnose the stories long disease As some their and, improvement other in these patients. of our reports term. in of symptoms

launching addition social In to SKYCLARYS media our these organic soon. stories, we anticipate campaign

to know living a and we we that help, can So off are to look people supporting we we're strong forward start, more ataxia there we them. Friedreich's believe but with

Which me brings ZURZUVAE. to now

launch we the mentioned, Chris several providers, with think by performance encouraged to seeing are and trends and date, of patient positive As the we reimbursement. experience are we

we are prescribing breadth continued X, adoption they prescribers are demonstrating is grow. which January. believe to providers. to Across the led to HCPs some types, quarter let double many providers OB/GYNs to of as only has treat. treat. Notably, first First, overall Furthermore, before often they with me a early just begin nearly the believe an compared multiple in we physician In urgency calls patients. prescribed of March few require number ZURZUVAE seen We've PPD see that encouraging

product mind a scheduled specialty that ZURZUVAE pharmacy. in Keep available through is a

We're specialty with pharmacy, this steps familiar providers a we they many their working believe to new that the patients. with these are required psychiatrists on support appropriate working generally so can be process for While OB/GYNs. educate could

experiences treatment. tell help platforms living are their patients believe shared personal that with depression. experience have HCPs Several of improvement postpartum and symptoms TikTok, sharing early depressive will of their their on reported story patients within we with XX-day like significant courage ZURZUVAE starting their some women in to some treatment Second, educate days have other

restrictions. ZURZUVAE continue with progress the pharmacy to have policies Many ZURZUVAE X others Third, in we believe the overly some formal without place, national burdensome cover place. without even payers already of managers commercial benefit we're Two of have good access. coverage providing been and for while policies making favorable, are in majority government which

as with a active are decision. third national discussions await We their in PBM we

states, we quarter almost And X, that of take can while approval. largest, accelerated tends the a longer, of several believe process after which to including into Medicaid FDA is to up unusual typically take the a half for reviews year

that we X/X support to will We policies as are as access XXXX, much throughout lives encouraged approximately of and with reviews Medicaid published their to restrictions. the appear minimal We coverage have anticipate to states possible. continue review remaining

Before handing with We and pass mission, these working help help that with and to making depression, updates we're to and ataxia we to Friedreich's we an responsibility Mike, have living to share it communities. that, over like you. that to to I'd believe I urgency postpartum continuing underscore people important to now Alzheimer's, in Mike. we are significant over With forward it to patient progress with look want

Michael McDonnell

and as financial Thank of focus as of endeavor seeing return XXXX. how make hello our but I'd quarter context note on company growth to in profitability first high-level this with profile are sharp versus a we We start well. our financial like you, a I are program. maintain Growth of to to the revenue improving growth just progress that Alisha, the overview we and EPS comparisons for to everyone. Fit any that Please not the

SPINRAZA both more the for year's products. be this revenue growth towards investor year, the as we the expected earnings X% timing well our our be this previous And second of of line, the to revenue the top during our U.S. to the we recent and profiles decline offset skewed quarter, for recently first our business. in launched in expect Regarding that shipments which the webcast as half outside X conference, we and our as MS more call launches due than contributed our noted will recent expect

of On due has This is replacing saw lower-margin our to percentage X we mix gross increasing as points shifted. contract the quarter revenue. revenue margin, product revenue manufacturing improvement in high-margin

XXXX, quarter idle We $XX of also in of million quarter none the had first the in capacity first charges of and XXXX.

Our our contributed of to our operating Growth the clear in savings These income expenses, and a on we as resulted and that XX% R&D SG&A OpEx, impact year-over-year. core prioritization for which and Fit of quarter, XX% had growth R&D year-over-year. during meaningful refer non-GAAP decrease to a non-GAAP initiatives

XX% was while of the improvements more And that are far, margin is quarter improve operating to XXXX. first still Our believe work these encouraging in so in continue XX% compared these as to quarter done the can we to metrics. be there

Now a billion, $X.X bit X% and the currency. during more of Total decrease on color which quarter. was first was dynamics revenue actual at a revenue constant

driven as franchise first Our benefited by global quarter. quarter. first the some we competition usual declined approximately the VUMERITY patient during seasonality channel dynamics in Within see well channel MS, that grew MS revenue growth XX% favorable the revenue as X% and and from

most TECFIDERA TECFIDERA U.S. of have Regarding the drove growth EU, in we for exit now this X% ex the generics market, quarter. seen which

to XXXX. of EU the are in until protection February We entitled continue to market we believe

countries now delivered approximately quick double-click $X a several revenue including where have Europe, in And SKYCLARYS on launches our in of the quarter. underway. revenue, disease we for million $XX million rare

up majority was decline of shipment remain XX%. emerging The and the For encouraged markets. in revenue SPINRAZA timing the the was in quarter, this in SPINRAZA due to year-over-year we U.S. revenue resilience declined the here. outside by U.S., X% certain

and throughout numbers the stable see patient We expect XXXX. normalize we to continue shipping largely remainder would U.S. of outside to the the dynamic globally, generally

the negative foreign impacts some and saw competition in also exchange We quarter. from modest

global to the low by we revenue year expect For a percentage. SPINRAZA decline single-digit full XXXX,

is channel of which inclusive increasing launch. any believe of in new demand, some for million $XX delivered which common is we anticipation stocking ZURZUVAE revenue, of

significantly in contract And we year continue to last batch lower guidance manufacturing reflected XXXX. for this of commitments And revenue year-over-year. lower a to number lastly, due was full be as contribution in from to our than the notably expect completing we year, line

an of of improvement cost non-GAAP total quarter percentage of and First was points. that's sales X XX% revenue,

revenue manufacturing mentioned, a improvement new related the to revenue. of not XXXX. favorable idle was product And launches it mix We in lower charges. from was did product driven replaced as As first lower margin also quarter having contract I have previously capacity this more any by

for decreased XXXX. $X track to net First expense the by quarter of we non-GAAP and driven gross achieved billion Growth, where savings by investment primarily achieve which from Fit of on end million $XXX of R&D $X remain cost million, was savings

savings also as We saw R&D focused prioritization, which has spend we probability have a portfolio impact a as on programs some discontinued had of our areas higher our have of believe meaningful we and success. result a

realized approximately reductions, increase our for an in million million the decreased activities related expense $XX spending LEQEMBI in Growth sales that by was products MS for with million which $XX the in a of XXXX was offset this first And included cost I SG&A due to connection quarter, launches. operational Non-GAAP of in primarily to the Japan. also support were in G&A-related on program. and co-promote and $XX that note prior Fit agreement will SKYCLARYS of in our marketing and year the termination

to of contributed above non-GAAP growing income together growth EPS improving, this with operating and operating now and non-GAAP X%. of XX% All margin XX%, non-GAAP

balance $X.X net with billion. debt and $X.X Next, marketable debt, and cash securities, sheet. of our brief update a billion We roughly billion approximately $X.X ended in the on quarter of

March $XXX loan, XXXX of was which $X time of of put place XX, XXXX, Reata million As debt included at the the billion $X.X in the of total the acquisition. term billion

$X $XXX a of month. which this which and payment we expectation $XXX the repaid does earlier year. of not billion this expected we repaid this $XXX As than to The second that end our facility. this of this XX, XXXX, year, so received quarter, March the securities was by I'd Samsung, note this is million from during million earlier of marketable figure be million cash quarter include had remaining original

during million generate approximately quarter flow to free strong $XXX continued first with cash We of free the flow. cash

initiatives. a in increasing strong to invest position So sheet in overall, balance growth remains with our capacity

this point, an party. received we biosimilars third our offer At business. from regarding acceptable have of strategic And review a not the

to Our ongoing, explore disciplined as we will all we continue and process retaining the business. remains including options, remain

full Next, I'd and year like guidance discuss assumptions. ranges XXXX to our

share We the are diluted XXXX range as the at of reaffirming which of approximately growth non-GAAP to $XX XXXX. $XX, per compared between and our expectation midpoint earnings reflects of of expected full year X%

on the slide, of previous to including unchanged. All remain guidance, this see assumptions you our those

we to success made guidance. remind the R&D associated our potential we opt-in that payments like or upcoming milestone readouts, these have I'd allowance of an payments with for have data and potential in clinical some

they dependent course, are or Of the whether on paid will not decisions. be data and our resulting

we At of just expect the they point, completion million. arise. review a support to of finally, And priority X our announced of investment for sale for to proceeds development vouchers business we these opportunities X as this business $XXX or earmark

closing, growth And to bottom line for and to #X sustainable in and remain Biogen value creating our we returning goal of top shareholders. our long-term committed

up the open for now questions. will call We

Charles Triano

Thanks, questions? Mike. go Jennifer, we to can

Operator

Instructions] [Operator Cantor Your with the Fitzgerald. line first from Eric Schmidt question comes of

Eric Schmidt

of immunogenicity but subcu finished lines initiatives until the recommendation. couple a and for Eisai we month updates just couldn't in had is also so, Priya, I submit the on CHMP doing, delay the could last was on the those time for I they maybe or this forward. update that you announced partner's approval your LEQEMBI, the And guess for EMEA going us of on know they hoping study. both I

Priya Singhal

Eric. Thanks, Yes.

subcutaneous the I maybe we start patients formulation. to with just that So saying are with Eisai optionality by working of really off can the provide

data-driven. approach entirely is Our

last at the to shared was So encouraged most very that we we This CTAD. bioequivalents and see we the year, important met were milestone.

FDA. engaged we've Thereafter, the with

just are how to this, currently, subcutaneous strategy split we've And we for approaching characterize formulation. our

application. maintenance. Eisai as to already earliest. submitted are we working at foremost, we it, as soon awaiting submit going for make we're auto-injector And will that. submission and to rolling submission. First has This a fast-track do a get for the subcutaneous we We're

required. for we the X-month the While that data continue has generate FDA immunogenicity the to

Second, it's was convenience. the higher we of formulation, subcutaneous that than IV in the more optimize interest and exposure patients to will lead because with to dose, our formulation believe

and already is optimizing something that dose, and are we ongoing this the is is that ongoing currently So year.

even for will fast time get fast maintenance, terms data because the would if X-month for this the file by track of QX. rolling lines, and expect year In we don't completed we we we in get immediately subcutaneous have track we immunogenicity that review, be the if

March. the we subcutaneous early XXXX. induction that already would of communicated their by first Eisai expect investor Second, file is That we in quarter for therapy, what has the comments

like also intravenous had Thank you. to remind QX filing we maintenance as by us aimed. XXXX that our completed I'd we

Operator

We'll go Stifel. to Paul next Matteis with

Paul Matteis

I XXXX. uncertain development was the wondering just kind to but until on trajectory development maybe stage if it as a how appetite relates context of to your And LEQEMBI we on capacity, updated something could in area, execute this, versus of commercial. get perspective wait the or business promising your uncertain therapeutic of bit influences of now

Christopher Viehbacher

Thanks, Paul.

into I development. and to this focused going we're think early-stage year, be to on new assets, both business development bring in research some

trials. this but the long disease underlying you the biology. slowly. is some a called very has don't neuroscience disease reality always of have area. that understand to company, progressed is neuroscience We high-risk ourselves We always expensive That leads a The and

in can't II. often You a do Phase proof-of-concept study

I And that not we'd it's already that think disease. adjacencies in like personal that too -- a is size. is to into for is while remain committed we neuroscience, year, company enough to diversified our view last rare my And signaled so go that of some

that. finding are special requirements, sometimes that we I patients. diagnosis, to commercial rare And do be actually there commercial tremendous and, of have we the to are able have of awful to with lot course, payers that of the disease. a the an all think I hurdles need think tools overcome There capability have be support in to

an since autoimmune disease. an company immunology immunology. get-go We've since is then the been really And MS

to use we'll that. the think expand licensing I So opportunity with collaborations

thinking is, be look think where if an have capability. really at something along, doing not balance talk you extraordinary to I we'd acquisition we right year I on sit the size. balance now, it. came certainly But about where this don't think maybe front, anything sheet our we'd sheet can Mike, any But

Michael McDonnell

Yes.

is that our would I balance very good just a Paul, sheet So in spot. comment

debt the that about net term the position first billion pro make $X quarter and in our of Samsung net quarter you for of it's at billion about look the debt. then forma loan, of the and $X payment We we'll that the on the paydown EBITDA. you at If end second generate

about only between leverage. of and it's X turns somewhere So X.X turns

certainly we generate dollars of we we per leverage that year. a turn So cash liked, something add and couple flow for at billion free temporarily, could least of of another

about be of a think billion logical you little And XXXX of interested a sort $X looking I XXXX in capacity-wise in. were then maybe really number as to in billion more probably beyond. So capacity it something context at more for we of that's Reata-like, or might that the $X if things

Operator

to next Sachs. go Goldman Richter We'll with Salveen

Salveen Richter

For has speak any then the penetration that about this? and XX% peak and and expectations penetration, net to a Europe U.S. you how dynamics pricing thinking SKYCLARYS, could And U.S. about you being are for specifically, XXXX market pace impacted you've outlook uptake of in talked there? in bolus the the

Christopher Viehbacher

want and you Alisha, follow to up take with Europe? I can U.S.

Alisha Alaimo

Yes.

catch-up we've the saw as made market and you it the you when far. gone the has probably U.S. I also very the thus analogs on said, think the look launch on sort that penetration, of And the I population. and at through slide well

identify things really We of to the of now are to rest get parallel, have and that in launching we good in a place hopefully right lot population. the

X The way this patients. though, about we do market, of which sets think is have we in

another have over their X are been and have set last years. engaged set you that to X who highly haven't probably engaged You the with physicians, a

how and to exactly patients where data have are and understand have We these them. enough moved the through analytics physicians

with be these community we offices, X that And general the so with have but ataxia diagnosed now patient could might Friedreich's. are not or identifying a who of a that, lot in especially

expanding what have we footprint, these so referred the is field the very I on approach offices, force market to And to call order the earlier in a again, targeted to, penetration. increase

that marketplace. there's there Now are X,XXX get though them a well market, SPINRAZA, competitor quickly have know as we've Friedreich's as we're you and market that good as can possible. the SKYCLARYS, with no can a with we in even of approximate planning driven really penetration so to for also next see to doing product, competitors could in We what patients several as something everything that is we quite over many to continue with have the this years as the also expect With performed ataxia, very we like penetrate to as and far go.

Charles Triano

Alisha. Thanks,

Christopher Viehbacher

lot for And there those system have ways, A even Europe, And single-payer actually of hurdles really reimbursement, awful are insurance in care if of we coverage, of don't that some Yes. patients. even the U.S. lot ideal you are really Europe. have you an a the lot in health systems on see patients in U.S., on rare the imposes if diseases.

a And so I seeing rapid Again, catch-up uptake. think we're there's a population.

there's revenue-generating -- between a So and patients patients. and difference on there's treatment

can launch come the countries we go relatively because in up our individual actually we processes. Germany So as online will have we through actually first, build the patients. commercial get reimbursement But Other quickly. reimbursement to objective country is

So who are these number EAPs. moment there's a drug free the through on at

for. can you charge of Some EAPs the

lumpy little but revenue as a So I'd by to uptake of it's extremely line, we we're be look at going the patients. say encouraged the

story XXXX. Latin well ex then for a U.S., that be And America, in could

see first I may of launch our part in Brazil think in you early XXXX. the

Operator

next to go with Evercore. We'll Umer Raffat

Umer Raffat

was impact whether response B impact knowing different you between trial, I to I I how late-stage antibody the dose And readout instead actually realized that on efficacy for XX this week a XX. know of week doses one is, there may. also prior the wasn't I duration upcoming help readout lupus in clear summer. in time with the cell the and I on could CDXX readout? Priya, this cell question my the guess is this the have the speak could ligand prolonged point there's B if

Priya Singhal

Umer. Thanks,

activity. at the And and looked for patients a the for BICLA decided have severe for Phase primary endpoint study we looking have secondary endpoints the included we're Phase II change XX-week the very achieving carefully. key and on we ultimately, such III meaningful We study. And disease low endpoint on prevention as flare SLE this and

systems BICLA that composite disease is improvement activity worsening escalation all or background in clinically think need and requires for of meaningful a without severe baseline and across medication. activity also with SLE sensitive We the body the moderate measure disease

trial. the modified we've So

the that of as is kind we we really population. are important readout. to We going be this -- And the forward we have look to think refined

keep considered population to and dapi here potentially mind can we modify think, for an piece, in quickly answer to study other the get to that I The the is how to really we bring patients.

that, your I So answers question. that hope

Operator

with to next Jefferies. Yee Michael go We'll

Michael Yee

it cetera, I wanted to to revisit were just revenues this this planning And SKYCLARYS. of you to Germany et how the relates you SKYCLARYS you will discontinuation revenues about offsets comments. talk trajectory the SKYCLARYS rates, So I know that into month-to-month. for you also et book any does it? of said like year add dynamics patients also, about as just Can talk factor year? cetera,

to said And clarification, that's if for LEQEMBI in QX you induction I I Priya wanted 'XX. filing clear said. sneak what one just subcu may

Priya Singhal

outcome The we be optimize in and period. forward. more once on dose we'll communicate and filing the that Yes. the we go But this will

Michael Yee

Okay. And SKYCLARYS?

Alisha Alaimo

Yes.

it we highly quite we're for you are, the We start now. I know we've population, via month-to-month, they engaged physicians. that because through have getting and will I pretty say, SKYCLARYS, will is captured So out absolutely are for patients, the which say, that the who much complicated them obviously, maxing forms,

on you're have being compliance. dose that have to have then then, going to forms discontinuation are you're start you patients then there's a miss off And So have of noted. may a X, product. going the you also pulled putting or as course, to And rate But right? them

single give because every that number, which have a specific the I you but you can't for will population. in you is patient dynamics continue to add be we patients, going is say lumpy that you So the add But our other what on month. to are month-to-month, XX then going year, outlook can

the takes going find numbers. there other still are disease at We generate of are rare to the and patients But to will able community and we we in puts leading that those penetration. analogs those and are that we're ensure market day, in the the end

Christopher Viehbacher

you actually we're And And the in revenue for contributions some Europe. and as in XXXX and we're a will actually, in revenue we've in charge Germany. launched programs And be too. for booking in in early actually but some EU certain in revenue come able that to XXXX, will Europe, Austria Europe revenue access countries, now Yes. Czech well. countries probably certainly the from more down, full region Republic of see there But as

Operator

Colin We'll UBS. Bristow with go next to

Colin Bristow

one the Maybe on LEQEMBI commercial setup.

So footprint. and had you wasn't a remarks, sort an investor able U.S. the I concern sales XX% expect some heard planned being based always commercial current footprint been quantify you're it or than around there Are in was from to of marketing increase saying from U.S. prepared the was the is adequate? we've on presence you been the current expected. XX% important increase And footprint? that physicians or hearing feedback your less perhaps review

Alisha Alaimo

much very Thank you for question. the

being running. going to this sites the said get giving beginning back look while were stepwise from wait going overturned knew to take and and We take launch, we that were a for to that we We a NCD do PET. several CMS indicators full we to looked to step always at you're how a going up If at strategically and for had from approval in approach.

that gate to with field impact said, the the with that so huge market. penetrate wasn't to go didn't we really a able or force And out of actually want being

is care. that We the was we it's on focused expansion, that once really think gets we will And what top ready a diagnosed we with we accounts for are patients, especially where think the the decided under to the in expand. market very approach. went then handle instead, neurology place So focused said of we a majority

lot takes effort. these have to and different up Now to a not X, also think into want really people comment you the also of these seeing physicians support. context your have back running I X they're to And have going we accounts a sales efforts, of X, about don't coming to saying of getting sites lot

been on large really And the focused very so IDNs and getting up running. we've

these really come up quickly, could move them of that have quite centers we Some and forward running. that got

come extend diagnosis you of patients going going IDNs now to through to allow And focus XX%, place opening take satellite where mainly up treatment. on larger a to the the offices see that the are for now large they're and their with now as expansion cohort expand are and we

going next which And we this growth. so done with a and is third to weigh right of phase we appropriate is analytics parties of be this sizing, the had acceleration in lot of it, believe the we've Eisai a believe on we've the lot behind next to and build, what a footprint of drive that

Charles Triano

to me question just back Yee's And a for to clarification it let Mike turn Priya on...

Priya Singhal

you. Thank

fiscal the to fiscal for subcutaneous wanted it's Just which XXXX, that outcome is Eisai the 'XX, year -- clarify induction. by year QX

a to But Of which be potentially other that what such it would it communicated. could aspects it. is I just involve is because sBLA, Eisai has that and that priority the could -- wanted course, a that. review reaffirm range -- shift

Charles Triano

the outcome earlier. The not Obviously, filing. and

Priya Singhal

Earlier.

Charles Triano

Thanks, Yes. Priya.

Operator

We'll go Markets. next Capital to Brian RBC Abrams with

Brian Abrahams

you I'm immunogenicity a sense what regards that subcu, to the as have for With request. to drove FDA request LEQEMBI curious data, on if

And dose? subcu to transition Your an the in level then half will a the should are that subcu from course of IV their maintenance? that using be of treatment confidence patients linear PK when proposing you

Priya Singhal

Thanks, Brian.

substudy tested extension Clarity population overall, was in open-label know, had milligrams we in So we you patient AD that for as the the subcutaneous. -- XXX naive the

we what is to the are that, in FDA requiring had proposing XXX data, data. are of a to it. in see the the is we and addition and milligrams immunogenicity reasonable this from And weekly be Now that, this just request, for additional already modeling process We generating as we maintenance.

who be tested So is actually the overall, about in expect don't and that immunogenicity question. This patients all generating to really would this. we going now the for bioequivalence be is

that. we what that's So with expect

your question? what second of me remind aspect was the you Can

Brian Abrahams

should transition When proposing what Is the there patients -- when from happen? transition data the subcu are maintenance? supporting course to that you IV treatment in that to of the

Priya Singhal

maintenance, because The we study, III. this completed that's important in from X I a come really, extension Phase an that think 'XX. Yes. like as open-label intravenous QX has And XXX, gap have filed as Study already II well evidence. we which the of period modeling, filing lines was for Phase the And

following the from is maintenance on be time filing. now what our weekly, maintenance along the weekly. for that, biweekly So really, will with decided informed discussion. subcutaneous And in it have FDA -- to appropriate we'll IV, that's X the to what's And addition, IV transition

maintenance. in we So SC that sense. maintenance. And get first really, to have hope parallel, and all IV the we it's very need systematic the through I makes

Operator

with We'll Olson next Oppenheimer. to Jay go

Jay Olson

that plan like this commercial Thanks launches you're It in focus? update. on And there more seems for you reason work on how to to R&D quarters, your the much shift do your more pipeline. any portfolio? X compared relatively for less do focusing Is to R&D particular providing previous optimize and

Christopher Viehbacher

I I readouts think first in mean we I'll midyear. data X have start. coming

the need from make we've largely or data of we to think to of nature They're when I of job we're view, data. done R&D more projects and would think data say we've got conviction back either I we sense and And more a the that here, the outcome. the felt the actually, I wait when we'd in awaiting prioritization but in have projects of are we you given bring So projects neuroscience data Priya, projects, can just see having weigh where say. what flight. point

progress not. we find us disciplined going to about much or think more I you're whether

I been for clearly defined have go/no-go decisions, all think, those. Our

have I pipeline, than as in we talked is really build about that next to diversify the past. to our job now out want little earlier, more a think we I the the business bit

want we certainly is outside. the with add can additionally thinking about know bring along to Priya I from working But, Priya, you don't things pipeline there? what into on Jane anything So

Priya Singhal

Chris. Thanks,

I you right. think That's exactly covered it.

excited X readouts preparing We about for are very are our we them.

criteria. We through have already worked go/no-go

that's dapi AD, with as in SLE, in programs cutaneous particularly And and X talked about, rest of litifilimab III as well that as litifilimab very remain excited also late well to Phase in about pipeline ASO just with stage, anti-Tau our our and the we continue mid we as lupus. the

about trying we that sure be So in phase to disciplined a number data-based we making projects very have evidence decisions. and and of make we're development, early

Operator

Sandler. to Piper We'll go Raymond next Chris with

Christopher Raymond

Just maybe a on question strategic dev strategy. your biz

So comments I your diversifying away heard Chris, neurology. from around

value, company an business some if focused early been presence. have But the lot and across And and industry, saying while, with our for MS. your still indicate there innovation with a than Biogen on checks there's remains that the a that is market in I other have would actually, decline, guys deals awful MS. you decent your even that areas of You look argue, in trusted

guess it question you haven't of strategically? worth the your just the the to MS Or view in an you strategically, is market underlying your is asset of away a is that areas? diversify here early guys just activities business seen is to licensing? Or some led that MS other have maybe need prioritize dynamic development, due view there to that I other from

Christopher Viehbacher

Well, there's a lot there. little in of bit of above a the --

is haven't the enormous fact whether to may a to I QALSODY not the approved need where tell you up to this financial indication can fact, And have having working be in an ALS. but very really a be we think major in But a the think still unmet progressive scientific in after. It field research first biomarker not in that actually is proven or achievement, achievement. MS abandoned we MS. ALS. is really have something in I programs a really it's do programs was the early. opens has which We tough form, go The has narrowed, really

programs And we a ALS. Huntington's. of in so have number We're in

as see conviction as Parkinson's, and programs program have between the We've we in Tau high got you know. We a company. [indiscernible] think, I which within lupus, of

look predict, expensive, many narrow. There's that do running. when And deals, space. field at wouldn't sit we with is, well I But but we MS, very is are you're programs So say -- neurology. there that is external actually people just not in right, In I placed. the we neurology, that very are that ability very long just the to think also to very feel that reality difficult working CNS the very you

amazed I really have Biogen. we're by fact, say be capability the a source diseases it. at fact pride So continue go and we organization. I within And no the these that And we have really talent of within to the after in to is means tough abandoning

lot the oncology us moving is diseases, R&D. or like left-turn of out I ever see rare company. that. think don't -- have of But in in do think something in predictable immunology. I we reality have that a But the we within need I to results legitimacy into and being And expanding capability do going a more have we

in In that lupus, fact, what and, an really in I is we've fact, indicator been think doing that. MS of

portfolio. diversifying continue think But collaboration So branches branch our not it to for set and our we're I going to out opportunity out. also just

Charles Triano

our question Chris. please, can we Thanks, And take operator? last

Operator

Flynn Yes. with Morgan We'll go next to Stanley. Terence

Terence Flynn

on part X Maybe Great. LEQEMBI.

force quarter, so the here number breadth the on just Just any we unique prescribers treatment from And the wondering, about then more talked than through seeing much doubling you're this you as how expecting insights far? of early wondering more field think expansion that you're forward 'XX. obviously, of duration about

Alisha Alaimo

Yes.

So question. for out of phases outlook the you these the fast, that the thank the you is year when even about you think the My in these And rest community. do really in. small IDNs for are move right, they see accounts,

to to you're back And approval is really increasing, are got continue approval about full if these now to they increase look I to large prescribing And see -- an throughout year. a in the get believe the the these that that for IDNs, the X physicians of going X for fact it staged of and actually take step will you number talked that very we rest systems months I and which organized, opening phased other also in up It about. took and diagnosing and sites approach for context the prescribing, July.

still numbers at good the targeting a actually look how are prescribing, we delta and there. that are you have physicians that many If we

XXX. coming the I drive And IDNs. the so actually prescribing covering expanding about really they're goal, that. And the extending. than target our quite talked priority also there more force is are do referring just But IDNs mind, especially see to that to continuing, I and I we you field of acceleration with that priority. other are and many keep keep these also in to large if are the in,

your of part around second duration. question The -- was

of many that, very therapy, lay staying X patients physicians we've And on sites, of thus this specific with far weeks they to is physicians. when on seen that and get is these lot feedback patients to hear interesting prescribing and what's we what product. We are a infusion there's expectations on they their their from happening with go stay explicit they been in expectation thus come as be that know conversations with You every the product. and what far this, and IV believe

data the we also from that We that hear see, the we that numbers feedback as see.

So with patients so duration, product. they're far that the plan keeping is on

the I think duration, do as there of are patients but in absence to physicians what are questions data, out keeping on. there about any to

Charles Triano

of Alisha, us available rest today for the of all IR team, Thanks, and your thanks And day. you the good for follow-ups. is Have joining Right. of call. for course, to a

Operator

participation. This does thank conclude your We today's for conference. you

Biogen (BIIB) 24 Apr 242024 Q1 Earnings call transcript