Biogen (BIIB) 1 Aug 242024 Q2 Earnings call transcript

Good morning. My name is Anna, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second 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.

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

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

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

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

Hi-Bio move and you as comments, by President as We'll to Alisha Officer, I'm America; Travis Chief on get through we'll we Head make call, many Murdoch Alaimo; Q&A Dr. joined today's call. question. allow one Priya Dr. introducing On and to yourself Development; Financial opening our Officer; to that of Chief ask President Mike the and to Singhal, be possible McDonnell, North our some the and us Head of Executive from Chris we'll limit questions Viehbacher; then and session

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

Dr. a cover We to studied immunology like welcome addition to Chuck. Murdoch. team, Thanks, at and as road then got first, is and a to scholar Oxford. a Travis who Mike, I'd trained a team, this in Priya, our But morning. Travis lot as a to gastroenterologist member Alisha our physician regular new

to Travis to of became McKinsey, SoftBank, and Hi-Bio. the at and I'm Biogen. career he a team the Founder Following Rock Hi-Bio and CEO welcome pleased Third

West the Coast felzartamab. a team again, and of collaboration on drive with Now presence Hi-Bio the their will East forward have, development colleagues Biogen the the on working in Coast

results quarter really has announcing months. strong quarterly really a I this that this lasted say but is XX we're morning, So would

reflect had company been future really revenue Team earnings the the our presenting X months a in last turn for we're to new outlined At transform declining results XX tirelessly the profit. -- company. that Biogen XX of for been hard were the we're And think I a that and pretty months February really years ourselves. X work we and around of create XXXX QX we have to in priorities. we for working ago,

The was first on new launches. focus one

Second was our to base growth and reduce resources opportunities. align cost with

in was existing setbacks the along few Four R&D to Third the do. and way. was external But most five the important what improve profile. in on nonetheless, has said would promising investments it been that, that results We've today has done show me, always portfolio risk-reward and had growth. it I to our business. optimize to focus think assets really a our the was Biogen And

one take I those. if each So of

think if the expectations. either look are our in product see line strong we to of of new launches ahead are successful particularly I happy a at the also the for I'm that. And launches, or data more results very about extremely in Japan. early in not LEQEMBI, China but and only the talk been from all very U.S., will promising, Alisha there's launch

that, on that. that improvement that for where launches of things growth I'm about we in assets turbocharge talk of lidafilimab not strong is more to in the the only and But and in of [indiscernible] of and margins, talk beneficiaries the on you but the the we to we in key the more reduction to really [ one margins, of OpEx, but and in about trying ]. and base, although on base particularly is one cost out Last have other see that another some P&L And our really those in need see also we LEQEMBI don't on track is Mike cost can are will our we've set than year, you massively but reduced delivering R&D. both our the proud reduce one opportunities, the very improved will invested results, and that Priya

portfolio We though a where still have seen from a declining -- we have we also although of particularly and generics, to we products from increased competition, still MS had due biosimilars number is had a was SPINRAZA been hold I own. think its space. some And good performance. SPINRAZA. long one And we've protection. has able very And patent to seen very competitive This

of think decline that. most predicting people when joined were I company, the the I first

I we say now and countries be then. every tends bumpiness to Today, in where some the would only ship

think example, year. per Russia, do for in shipment we I one

an [ little that again business VUMERITY product market done has pleased look is patent ] her opportunity, And lot This But of glad digits I has that. think of advantage bumpy. And protected been the in U.S. injectable to see stayed taking I'm bit part, segment team well. share, of I'm the now and constant, a at really and very see Alisha MS. the extremely growing double a awful only in it's in you always segment if see So great at oral we much but has the the oral movement to pretty and SPINRAZA

And U.S., be strong year dividends. I We're the pay transaction really going also always Europe. said to in a to not the is external but last launch we think now to starting Reata in only we then growth. seeing And open were very

the this and on that happy countries you think is launch that. we're huge the patients addresses ZURZUVAE in I end As extremely in patients. of access to excess need, well unmet to we And then also get follows. we with programs and reimbursement a But know, year. XX ex expecting are of approved tend by be

last are we've the would the sit I what say, not, as of say that are that starting demonstrate quarter. seeing to year, them. I the we're in as of on really So scores those and deliver really, initiatives here I that think starting you're just to place now But today, we're put putting results on here done up I in the second all scoreboard we results

to think sustainable do And growth in a course, continue I we're that we'll opportunity a real Now not there's X and platform ways. develop yet. done to of

future really is us we franchise the that think The treatment. that but there'll we've being a the I LEQEMBI as core the the coming data indication, if this it for tau years. I AAIC AHEAD heavily have for of emerging can modalities. is with study, be for the as will the really early obviously R&D. And of also, to portfolio always prioritized demonstrate XX-month Priya now really I in will for treatment we importance week evidence growth showed other LEQEMBI about the extremely known important the that modality at we extremely see but important Alzheimer's Alzheimer's. the maintenance first the invest subcutaneous. of it, an get But talk think We're are continuing

I cutaneous about in an And excited quite clear lupus. that as We'll lupus a with have think a about readout SLE is we portfolio. year we're both that, Biogen We're this Priya also later again, and UCB. seeing as with leader litifilimab, more will well But for emerging that. say share dapirolizumab

with nephritis. important but for This the portfolio this is profile. opportunity outlook. actually of set a I And the will in add to bed longer-term extremely of lupus lupus because is go present me, opportunities we acquisition HI-Bio Phase And element more, that risk PELSA our Travis that [ for to another a growth ] an and is into have to different

than III lot portfolio. We results confidence a have us some of we very that our assets whole strong Phase in more have II results, Phase which the other gives in

area an but and very of in a one of unmet need, the it's also is Neuroscience hardest important riskiest areas.

by think and so excited things in our can about I little a I and team PELSA Travis more get so balance and personally am we immunology do. in [ And ] bit his what pursuing portfolio extremely

business we're is going access other The development. at to continue look to to this

you that have pretty we're disciplined. seen think I

I think shareholder business of mind Reata awful top of and development. will that drive done as far that acquisitions is the we an [ lot and of HI-Bio value, at that look ] with so we've both certainly

Biogen I think at we're positioned a So We for XX ago. company. a the now challenges in growth longer-term number different of were much we think place still like really have company, other I is than months any

a And like it to to us over give on Alisha turn color more the with little to that, I'd launches. successful

joining and Thank everyone. for Thank you, perspective the Today, Chris, today. I'll ZURZUVAE. on you SKYCLARYS provide our call LEQEMBI, good and morning, progress of the

since we're across the I So promising launch XX% Alzheimer's continue to we in volume having all patients. patient the momentum newly the treat therapy more a sustained of country will Nearly market. new on begin systems higher build health during commercial trends now these saw we started capability We Alzheimer's with treatment to patients of QX, with QX. growth. believe And continuing

compared and depth grew more of of demonstrating July, are by to to LEQEMBI total Priority on IDNs physicians that prescribing It's launch we important continued weeks of in we've these know QX. to number ordering our seen based And at date, again accelerate order the data the that into to than the first XXX QX sustaining doubled The volume progress. trends also XX%. continued

health that be may believe positive increasing. seeing also we're capacity system We signals

play And how IDN patients described child flagship beyond the out of XX% to seen well. care. of treat priority some expanded as I sites activated this expanding their Priority quarter, QX, have last beyond we example, their extending dynamic Through XXX are their For the sites. nearly IDNS IDN sites and at

We profile believe newly efficacy growing this strengthens safety competitive its further real-world in unique LEQEMBI a with and market. experience

date, disease some share removed. considerations Alzheimer's not of population and potential HCP patients fatal some that in which to is a that the is was the drug diverse Alzheimer's and most for removes studied appropriate are because LEQEMBI does it complex even broadest plaque stop degenerative chronic treatments. of anti-amyloid after about any Specifically,

who In fact, rapid show plasma patients of indicate that key that disease treatment was long-term Alzheimer's stopped data returning. LEQEMBI biomarkers reaccumulation our experienced biology

a stopped ahead benefit patients and Importantly, in in say disease preventing risk after progression profile most rate believe is observed damage decline of buildup. remain why were rate patients the treatment even patients to that to verted who took therapy we therapy a of enables on with ongoing decline plaques which removing by placebo, deserve to who of them the plaque

of has Recent were lowest ARIA who reported years been for trial and LEQEMBI continued lower. therapies. the are The benefits. ARIA Phase this showed among approval data treatment patients X available Observed any timing of XX% FDA LEQEMBI in that traditional with the FDA comparing in drug incidents finally, class. with class nearly And III rates describe no with that studies clear in a among received head-to-head patients rates vary drugs continuous in Priya the will that LEQEMBI there reinforces the

partner, and sites our profile deployed to our the high-value increases customer force To our is more working by HCPs. healthcare and July, positive Eisai, and believe expands Biogen growth been our field and last disease. sustained community XX% reach and we X expanded we just closely receiving with we encouraged the customers, team. people will since insights, growth. more our with Alzheimer's Biogen's to engaging reinforce We've in this living LEQEMBI's deepening is We're of even our enable support more frequency, the team look This field month. this unique feedback force focus of to with quarters accelerated strong progress with and providing and launch forward

is population. internal the U.S., World, strong Now patients and now and are initiating and moving revenue we their expectations. care delivered in EU, remain we In available in builds in often SKYCLARYS our awaiting HCPs including the on highly of in globally. of patients launch XX is new Rest launch the catch-up outside SKYCLARYS These our ahead typical of launches. quarter, rare continue engaged update, disease we in SKYCLARYS patients with the [indiscernible] approval second where more as along Europe globally momentum the is internal million forecast the success for their and U.S. reaching on $XXX the ahead to are where markets

long Globally, patient and a of In engaging meaningful the in includes patients patient FA writers We X/X market been making to of the team we roughly geographies, of available strong with term. U.S., anticipate QX, expansion pediatric encouraged SKYCLARYS and capabilities tied the more we forms populations by rare came our we AI is year. thousands our than can early continues In and de-identified in by and to share have SKYCLARYS help. has potential and promising driving as new new analyzes strong catch-up into experience This patients, our for are phase. hundreds moved leverage The PCPs. from growth start we additional population identifying the believe from this years in in journeys. neurologists which a community beyond our outlook both next short program results of in physicians disease of

Turning and our patient with ZURZUVAE to the X months doubling on with we've recall media outperform recent patients to revenue ZURZUVAE, OB-GYNs outperforming continue lead We strong experiences versus demand their social are among psychiatry first of early prescribing health and saw first providers, and we the growth Based platforms. in our believe XX% market awareness we messaging of the expectations the continue to aided in research, higher-than-average growing physicians positive quarter quarter. sharing launch. U.S. nearly and on analogs women's markets. in achieved second

remain expectations more urgency help across of X We or we behavior and have opportunity pleased launch work are to real [indiscernible] this are In to to that [ each advance of are more patient these unique, therapies. and To our Alzheimer's, with achieve we change. working to ] we help we in the to how patient postpartum transform people phase ahead do living on our communities. the vision is understand working and to while next market with depression, growth deeply depression, drive the we conclusion, carapostpartum all and know realize track

I pass Priya. will to now

Thank you, Alisha.

now have of focused pipeline value. eye our Over year, both improving and The toward its opportunities with existing external profile. risk the with we is internal eye through pipeline creating an on focus towards last combination heavily the a risk building diversification and on reviewing an

believe have a product we differentiated win as We disease as potential well an of in pipeline where focused Alzheimer's on R&D industry-leading in LEQEMBI next-generation investing we therapies. also to remain

the LEQEMBI. with. with LEQEMBI antibody is Beginning only anti-amyloid approved

protocol. a action, toxic First, both dual targeting of planks highly mechanism amyloid and

Alzheimer's crossed individuals the third, early population, with clinical disease extensive and including And Second, evidence. date real-world low no full tow.

progressive to dual maintain option is disease treatment Alisha the or chronic of with LEQEMBI further a for benefit. clinical looking for the action Importantly, mentioned, continued unique advantage as is a Alzheimer's disease and and patients

which the well individuals cohort this history To LEQEMBI data from the this ADM and the the start matched over study. started group left, who who the the earlier extension, XX-month CLARITY a AAIC III continued during early includes arm LEQEMBI benefit X-year start clinical duration baseline group patients shows treatment. point, on study from Eisai of of openable presented week, at start placebo-controlled extension or this longer LEQEMBI open-label Phase with Shown data its switched the Delayed placebo the to portion ]. as as from [ or natural at from

of decline shows The to is the clinical early a benefit important years believe block patients. home represents the treatment cohort, in history significant and successfully the benefit community of change in slight independence. at resulting that had the early majority XX-month start X a affairs, time on meaningful of on memory, mind hobbies group results We an XX% continuous LEQEMBI CDR This approximately that these to negative AD X.XX domains compared already impairment observed natural very keep X.X clinically individuals from loss between cleared by by difference XX as is the as It for point. [indiscernible] the X CDR are reduced of and months. of score expansion to

treatment Alzheimer's as early Boxes. function Clarity either from baseline assessed that removed. a study X-year is average Furthermore, treatment an Eisai the CDR-Sum in by interrupted Phase on of or stage soft data to Also gap tau cognition Lecanemab blocks on no AIC, improvement study showed of which years and of data with progress disease presented over even X period in right, patients which from Alzheimer's approximately continues after XX% that II low when a shows included the or are shown the showed at of representing AD

may data together, of to that Taken significant disease impact Lecanemab and on provide Alzheimer's disease initiation these suggest earlier continued term. the positive with have a benefits with early patients treatment long may over progression

its optionality preclinical for evaluating of We its providing role as AD continue Chris LEQEMBI as a to with benefit, subcutaneous well on characterizing goal with focus as population, our efforts formulation mentioned. dosing in long-term

negative the Lastly, with disappointed Lecanemab patients. treated meaningful further the and risk evidence real-world we thousands globally Lecanemab efficacy from that manageable clinical benefit the a been profile. benefit to believe we clear a CHMP, profile a Furthermore, were supports data received of have with patients favorable opinion learn on while now that providing clinical safety

for are We request with to as people Alzheimer's the globally. to a work EU work continuing Eisai enable they from as access reexamination plan to of filing we suffering

amendment implemented Phase in now Phase the the accelerating with we invest pipeline, Alzheimer's on to potential ongoing aim continue based anti-tau also broader of study, encouraging outcome. a including our CLIA the BIB protocol a have We Ib our for study ASO XX from data II investigational the proof-of-concept

excited date in a readout amendment, with are We may trends to observed combined robust this that XXXX. enable the enrollment

] Beyond advancing AD in pipeline approaches. active including amyloid are guidance under and transport encompasses tau Jane's and and [ research, we diverse a modalities, targets preclinical

today communicated earnings the with Denali. beta we ATV collaboration in decided As exit A to release, our

see into to efforts can build in leadership AD. we merit agents work in to continue and that transport continue these modalities we prioritize as to brain, our therapeutic upon We actively the existing

continue based pipeline. while X of few over readouts, the make other to last we back discontinued across Looking progress mid-stage our months, products several areas we on

Friedreich's study patient Phase SKYCLARYS received of identified, And pediatric a population. a the the dose-finding pediatric in a to we III risk Phase for I SKYCLARYS to patients. first is has conduct access potentially in expanding first once to ataxia. the plan dose is pediatric step The Biogen's benefit dose assess This study in

We SPINRAZA also out the second to this evaluating high-dose year. DEVOTE in of expect read study the half

the where the completion Phase dosed Phase II/III in portion immunology first Phase in progress study III in of following enrollment. II patient AMITA the We seamless of have CLE the also the made litifilimab operationally meaningful was

to continue potential future growth HI-Bio Biogen's immunology we example of the this recent is importance. and a as view mentioned, Chris driver significant an acquisition As of of

hand to like dive Travis call who will into the that, felzartamab. over With deeper bit I would to a

you, benefit unique with the and opportunity lead believe or late-stage global work to Priya. here of very to I combine have expertise accelerate will Thank Biogen today I'm believe Felzartamab in this development team. synergy in speaking part immunology a [indiscernible]. excited we specialized development. significant as our Biogen's Felza, we into to and have asset, experience commercial I indications HI-Bio's be immune-mediated as

we CDXX that believe As antibodies antibody, producing sparing plasma lineage. molecular [indiscernible] is deplete responsible broader for pathogenic cells while target design and differentiated specifically Felzartamab a the B-cell

in is currently improved other more specificity This cells. for and Compared antibio to that of [indiscernible] believe durable a we different by programs impact desirable clinical profile. from development allow broadly differentiated and more for the more characterized efficacy diseases profile other B mechanisms, safety

Through Chris Biogen's a optimize indications. cell pipeline, one concept across rare peripheral clinical significantly of reward multiple Felza but of is demonstrated approach, has already of the Felza As goals that mentioned, the depletion to effort. believe advances risk acquisition the immunology I

rejection, or disease kidney consequences are transplant nephropathy so AMR, significant failure PMN see as nephropathy opportunity Antibody-mediated to available end-stage that conditions memory severe options commercial serious we and IgAN or patients, such and for here. unmet potential leaves significant primary lead IgA need, and treatment

indications generated briefly value to the Now see to patients. I'd felza across like the to highlight review for we potential data these date

of at responders resulted dire, not In resolution out felza graft X-month failure the AMR significant prior New ending retransplantation AMR published Phase England with for maintained XX investigational biopsy. than is and resolution X no Medicine, can period the transplant The and have cause treatments study, AMR XX% doses with greater Furthermore, to of IV the of demonstrated the versus of [indiscernible]. we dialysis weeks. consequences be week loss leading placebo for of here need the U.S. in agents X/X approved kidney resolution XX group. in which AMR a in II over administered Journal the XX% in

if are disease. replicated So registrational study transformative this these for we results, believe potentially a in

glacieicient where discuss or the IgA most IgAN, nephropathy treatment the worldwide prevalent chronic for Next, felza a we is potential I'd to which option indication has and another to glomerular like deliver depletes believe disease antibody are directly of producers which the Felza plasma differentiation. positive CDXX important The ] most auto be cells. IgAX both its [ with and causes to believed patients upstream of IgAN.

reductions after up is resulted on As slide, of shown to months than XX treatment the IgA last the durable cells XX more in in dose. months, which here

selective paired X baseline felza rebounding effect durable to a antibodies this was of after with period IgA and the selective biology These off immunity IgM IgG Importantly, protective the that over the levels suggest thus pharmacodynamic and potentially effect general prolonged results, that clinical for IgAN efficacy the IgG can completion conferred treatment. IgA with while data and months on the emerging a by maintenance for allowing cells there. disease of IgM have impact

Similar by reduction measured to the proteinuria effects showed in a durable as PCR.

in dose-dependent PCR, a Specifically, durable XX-month saw we the reduction out point. time there was the to

plasma terms of off it's note the treatment the nonchronic of felza supporting well felza to option generally therapy, tolerated of prior being the is with targeting cells, with months differentiation, be again. after Now in consistent profile of this to important than that with studies. more potential first selective for Furthermore, safety is improvement administration in XX potential line the

may be for believe interim patients. therapeutic potentially benefit which a lower provide of IgAN for results and window a chronic immunosuppression ultimately We significant risk could the these wide

PMN. to Moving

a immunosuppressive kidney mediated many such proven as and which to which and [ includes severe kidney agents, symptoms much XX% achieve chemotherapeutic of progress nephrotic is do severe swelling, resulting a is fatigue causes cause excretion of of care, from this ] not disease. too and that's urine and standard Current of in disease the which syndrome, a as increased patients syndrome the of in protein infection. insufficient leading So risk chase has remission of

stratification patients resulted the refractory the is reduction for both both cohorts and patients in X-year felza and felza well key of in time evaluated patient study, us well as M-PLACE at In a in response. with kidney which have with antigen provides patients, both anti-PLAXR treatment XX% II rapid, autoantibodies a that against durable antibodies in diagnosed which TMN a point. which PLAXR, immunosuppressive newly patient as XX-week as estimated treatment It's deep therapies, Phase a and up to as biomarker, relapsed

last Many than months patients dose retained the effect. treatment felza's felza, highlights the X which of neurologic complete durability after of response more

Importantly, And results, with of in moderate premieria. the potential when mirrored generally felza, a to was were prior PMS. Based new in severity. believe effect treatment on in these we that felza patients examining or on studies have anti-PLAXR line suffering TEAEs for reductions meaningful mild the with provide

In summary, the diseases II unmet to we date highlights contract and generated data the believe potentially of across of option learnings differentiated data best-in-class significant for looking proof to treatment these have and refine the a work AMR, felza on efficacy, be potential III and a HI-Bio Phase to profile incorporate clinical team and safety. immunologic durability now PMN across multiple combining and basis Phase further of plan. Biogen joint with I'm provided IgAN forward highlighted our to serious need. as the the treatment strengths we

next half III PMN first year. studies beginning IgAN Phase AMR, year, the and to initiate expect in with across of we Now AMR the

now like Mike to I'd financial update. over call to a for pass the

at the than constant X% X% everyone. Thank will actual on recent and all second currency. the at versus MS was we X% are of to core at constant grew revenue currency and the grew business. Total offset good some that $X.X which This team second was you, year billion actual driven the and I'd the and provide the make please of But quarter. up importantly, by by like launches, decline more currency. the performance X our acknowledging revenue our XXXX. versus to start in a pharmaceutical good currency for quarter I'm entire marginally of I our results, revenue prior that at pleased Travis, Biogen to strong comparisons color afternoon note morning,

$X.XX the grew vouchers. X to grown XX% have review non-GAAP priority Non-GAAP benefit the of PRV EPS one diluted our Absent sale, $X.XX a of sale would EPS $X.XX. XX% onetime from and to included of

sales. We improvement, XX% PRV was income improvement non-GAAP XX% excluding in also the reported which a operating a

and R&D for our moment. We more Fit continue where to prioritization detail initiatives, benefit Growth in provide from I'll a

And We XXXX will are in pleased raising details additional be year I our on full also few a range. moments, to some our provide guidance guidance. just

a for our second revenue quarter. the color more on Now bit

Our business X% there highlighting. MS franchise quarter, in revenue that few a are declined worth and in this dynamics the are approximately

First, to oral we the as entire class is higher continue or erosion seeing shift business the our of efficacy interferon a therapies.

we now helped have at seen actual market, the XX% in quarter. TECFIDERA $XXX exit at most the U.S. currency generics this constant drive of which growth EU, to Regarding XX% and million currency

grew at We we are EU as entitled XXXX. believe and February continue million. global since to quarter protection in market best launch currency $XXX its VUMERITY until the that of had to revenue XX% actual constant to

U.S. by high-efficacy due to VUMERITY and remains in share in X% oil competition States. terms class. was revenue within the the branded the $XXX declines declined of of #X benefited timing offset the in from million United TYSABRI of shipments which the quarter,

X% disease $XXX $XXX SKYCLARYS to we market $XXX up at Eisai represented growth and by encouraged $XX of included XX% of quarter U.S. global we SPINRAZA currency. was flat resilience actual here. and produced And significant in Full million and of at of at million the saw growth and million XX% at revenue revenue sales revenue currency on in-market LEQEMBI, sales. of approximately second with revenue was remain global was X% constant $XXX currency. U.S. rare franchise currency booked $XX million million. our by actual sequential declined Next, which that constant million

to on few turn expenses. I'll a comments now

was of product replacing growth a by in revenue non-GAAP percentage which a favorable lower of sales see more continue We manufacturing SKYCLARYS cost lower as Notably, mix. revenue. driven to margin contract

million quarter the IC of in charges no quarter the versus had also We $XX second XXXX. during

improve programs Growth R&D Fit for and profitability. our to mentioned As prioritization our previously, have begun significantly

highest the the million Second focus of quarter or from by of non-GAAP second with our on we spend quarter programs XX% R&D as probability expense continue to success. XXXX decreased $XXX

second in Non-GAAP the increased quarter. SG&A X% expense

and We reduced XXXX of launch absorb general SKYCLARYS. the have us products $XXX has most selling LEQEMBI significantly which and costs of to so legacy significantly approximately and base incremental allowed for cost for costs reduced million QX our administrative

with brief update sheet. ended and billion the of a quarter We marketable Now our securities. cash on second balance $X.X

of utilized debt. the reminder, closed We of acquisition. this net we billion a July we As ended balance $X.X when HI-Bio with approximately billion quarter in $X.XX the

During continued strong in of cash of brings to repaid million the the in that at of the to billion put second of cash cash flow of which of approximately loan we $X fully quarter, first in And the we acquisition. billion we quarter remaining generate the free free flow balance time the place $X.X $XXX flow, half XXXX. Reata approximately the us term

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

business of guidance. now the Turning a of non-GAAP $XX.XX supports pleased ] EPS to to new of the previous This range operating full range range We're approximately year compared raising X% the to XXXX. growth $XX guidance diluted the a midpoint XXXX expected between from year reflects new at $XX.XX. our full to year-to-date to $XX performance that of the of [

I things your the to you to XXXX would hit like highlight half several as important remember of second models. for

generally full the single-digit is key revenue, ahead slightly to a percentage We with when now expectations increase of slight a total decline to by year. expect our previous there year products to compared all terms in or XXXX. line In for performing revenue of expectations, the low

SPINRAZA flat also and year-over-year These which timing progress the incorporates we second of in expect a and key half to be potential dynamics the are monitor to of on entrant U.S. potential in for an the year. launches roughly pharmaceutical for some in for certain ex-U.S. core markets. continued revenue TYSABRI, MS include recent our franchise to to the We as offset continue biosimilar expected expected provide the pressure shipments

And This direct-to-consumer as increase a not of is operating this expect to launches. half which of include as on our online new regarding we force, XX% In is expect our spending spend year, ramp of initiatives expenses. consider additional the nonrecurring launch will proceeds some second item. X and coming the in X this campaigns. the year, well the we key we sale continue some priority our benefit for field to to targeted the year growth product the since LEQEMBI the to later vouchers reinvest impact Next, Also to review EPS. points our sale of expect do full

of incremental related addition, HI-Bio primarily we III the execute line on OpEx the of potential half plans X million in Phase as expect year on starts. the $XX back R&D In approximately we to

SG&A phasing of just year. We continue by of income to note billion of We year and of higher approximately spend the to now with offset the partially $X.X XXXX half to teen full billion. due typical non-GAAP approximately in R&D percent versus half some new combined expenses first half expect mentioned, implying half $X year, launches. also along the reasons guide the low at year a operating the a I factors to that due high expect the second in the the the year versus of grow second to double-digit of throughout higher in XXXX expenses would spend reported revenue year, the I This expense mid- the higher previous percentage of product of we in improvement growth. our first

and million interest remind would $XX balances reduction the interest in XXXX, you to lower cash I income income we of resulting due expect associated this of the and that remainder is HI-Bio acquisition. from approximately lower for a

transactions pending not guidance always, business large any or refer As to to important does potential acquisitions impact guidance you assumptions. often press or I for other as our from these litigations release difficult predict. to are our and development would future consider the

to is the to the the shareholders value business retain portfolio retaining to our believe review forward and externalization aim the open profitability. compared comprehensive the business, of before with review an potential provide our biosimilars business a it up optimize just for for strategic options to maximize Q&A, And I best update that brief we business. a wanted we within regarding of to After going

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

please Operator, questions. poll Mike. Thanks, for .

[Operator the Instructions] Your from first Goldman question comes Salveen Richter Sachs. of line with

X% just year this your the for to of year-over-year and for the can confidence Congratulations growth EPS guidance what trough needs operationally the on out focus of been level, company, there's and around here growth given point both programs through the quarter. product-wise for you the and on for being clean the play to as raised turning from just the a high the a given XXXX end At XXXX savings pipeline speak decade. earnings significant cost for prioritization, here launches year,

the up improve Biogen on which and top now also original mission savings on at the to cost initiatives. Obviously, focused which importantly midpoint X% ourselves operating line at very the line. and X% of capital bottom on the midpoint corner bottom remains program, Yes. Thank sustainable for line but And performance, you our shows that on Salveen. both for not we've growth to free question, implied now turned our the line, the guidance, only we're at bottom our and our bring the growth growth the

that's obviously, XXXX along perform to the franchise be certainly how and I bringing very we're hopeful So guide And back early and restore dependent out our And line growth. with line this that into sustain when job launches, a that the get much growing our we're next. the year. to the continues don't important. the durable. look to pleased going guidance progress We're on ability line again year. can we've is somewhat trough of on beyond and we stabilized, XXXX. how with line of bottom focused look the doing was next the that what able those say that more year fact continue have is top to the be MS really more XXXX we're would the with move part this we'll got say company to the we bottom about latter I pleased the say to as But in top we been nice to to somewhat growing year, and our you we've at to as years We're . Obviously, launches

Fargo. with . question Next Wells come from will Bansal Mohit

to This for And LEQEMBI. And this [ plan would And evidence Saudi decision physician? a process? the on decision real-world the need what I on your a reconsider? [indiscernible] reverse think EMA had from on to submit the be we for from safety Do EMA time that line to to you what's is question reversed? can Mohit. or should or for trials on ] confidence additional for efficacy about this be evidence convened

This you. Priya Singhal. is Thank

the along negative LEQEMBI. of are opinion with Eisai outcome for We at the very disappointed

believe favorable. the and benefit to continue that positive is We risk

Israel also approved it's Kong, United been you China, communicated major regions Japan, Korea. in of the the know, approvals as and in States, South world, Hong As as well recently, we've like

we the have reexamination and co-Rapporteur yes, newly I continue reexamination applying . The ] [ to a publicly, appointed the is you for work process. will process Raptor a communicated So and works can reaffirm process. we for that can with that way be

we was are now, we the believe issues the the are to we from receive are right data be report driving on that based addressable with would the would opinion understand that new would appointed with The So assessment wait that And the CHMP. then [indiscernible] rendered, the decision. currently, work and these we've them generated. to what

treated. thousands have patients at how be we shared CHMP the the look now generated and submit data, we have the to see of because extensive we real been we long-term as additional AAC, Specifically, we have in that and data to real-world engaging can world with and would EMA data

AIC in So long-term the data X-month long-term as safety. we have we also continued at and X-year benefit showed --

on would process original move the possible with new we're appointed, process Eisai generally this application. in than to be a So strategy. is very and reexamination would and that the SAG continuing It work faster closely

from Markets. BMO That Evan with be will Capital Seigerman

do of Evan And about program partnerships you Ionis out you you're syndrome your partner? opting program the ]. Priya. evaluating is aspects a now on [ thinking do evolved approach Question to of recently? for the ] more rationale of what the walk to It's closely Seigerman. Can me scrutinized with what How with when through [ Angelman some

really programs stepping we are looked clear objectively then before may those to that allow would readouts at be have our just if as data we the accelerating and considering. us made us I point option other inflection we that think as important be which compelling. pivot the back, pivot to well points And want down, to to can and we've I other that comments double externally -- programs we .

the exactly So approach regulatory is up program. And what based be to success that decide priority that is overall, the ] applied our BIIBXXX try continuing the and the disciplined. with in we no-go we That criteria. to technical And [ go we probability develop our that at be we all that, particular is to on we is and a look very a that going process Inhuman believe readouts syndrome, be data.

well in regulatory our interactions with based I on that we -- confidence our very biomarkers, as endpoints think or are as find compelling things regulatory tractability established regulators. pathways clinical on

about So Phase that's all think look investment we of these, how at III. we in and

with Priya launch the to at -- in said, what could products think to I If add, I just addition ability globally. looking also we're

to also are . just we and as the regulators not points the around be of U.S. interested evidence level so regulatory they And end in in and world the acceptable may payers and

come Next Michael question from will DiFiore ISI. Evercore with

the quarter. on Congrats

looking you're dose subcu and whether lead that I a for? if could any is the this doing the So EMA more was to updates ratio on risk-benefit wondering option induction optimal there's work

Yes.

and already maintenance So fast for overall, rolling the a the in as dosing. place maintenance, and track have for Eisai and we we've filed Biogen -- have to IV a communicated, we subcutaneous continue submission

currently, to FDA And We're are an with With the FDA optimizing at effort. XXXX. on we we calendar in track, U.S. have communicated, we've the initiation of subcutaneous outcome -- by this as looking on to the work dosing, this from continuing QX dose. on . QX year are the

in the process. in subcutaneous with end as regards application, currently, original favorable how can the application get pursue reexamination Now continue about down is we're path for your hope that's intravenous want LEQEMBI. would as at a formulation. outcome which of, just really And be would Europe of impact we in to Europe again, could to reexamination dependent well we is to on with question clear application patients specific that Europe, the to going I We if really providing this so, the the that options the

Sandler. will Next Piper Chris with question from Raymond be

This Chris. is on LEQEMBI. for just Nicole Maybe one Gabreski on

you to pushback, guess I sort the we're and work just I survey feedback of also given waiting in what starting we've after the in LEQEMBI to interactions see from speak and field? can are are those has look a recently uptake? any some kind less to and ready maybe hypothesis So ] starting for favorable with some guess the of approval our if guess And are could indicated wave be recent seen next as quarters? who benefit in a of the reps you experience I done and/or the [ having risk prescribe who of cost feedback to this, HCPs Alzheimer's ratios are whole. benefit specialist view that amyloid questioning maybe maybe neurologists of you to

Thank who I important to market the you we Whenever research, it's in asking, at question. Alisha. you're This research. understand market think the is for look

visited least look at prescribing the asking out the so we on who ground. the are currently research ask parse you market at field, what's and obviously when in if you're happening the and And When were to the physicians, ones been that who physicians The understand hard They've over by on the are who year. prescribing been really are the this They've ones ones ones the They're representatives. visited been by aren't. MSLs. that we've working past data.

then time facility. And and obviously to takes with get their running up them it

and location also in happening will a near picking product. up the the board physicians like see You see that some across other obviously also start then this

force. And there's on are And from is start field additional and at dynamics our of expanding writing. that a ground they And we've office. lot you well what go representatives, with here. call as office the ones that to the ones so actually the the seen We're on obviously now play with

that think important. I data is understanding this

all in order a I important. them the patient having their capacity think is understanding important up get [indiscernible] and to is diagnosed

also of these because really any on year physicians to really physicians more hear think And are hearing caregivers out, we're to I get the from starting don't that and cost some the now we're so that. having quickly. benefit. feedback more a And And world I we treat patients this can families. is really alone about the what and I has on accelerated impact we even experience try real is say patients importantly, the and think pushback

really not hearing we're that now, for so pushback. And

don't this to what physicians do And I And could that, introduce the of the the decades this to to IDNs. look the don't of the is seeing treatment and or this you attention tend the to you a their We're that MRIs this, me, practices the of amounts get PET you to of physicians lumbar schedule scans of institutions. if after number into more XX% strong punctures, of when add for from and lot increase do at have versus of heavy energy physicians say. and writing ordering pay time I the huge depth to through actually to processes, this a physicians conviction patients. investing of just And and the all very if in a treatment of importance they lift what

I as extremely personally, look where So at this, I'm encouraged by are. we

on to now enough need continue market, at since data that the but remove the just I evidence the we look to I forward can because we are this look building that growth launch clear that just the partners for not plaque. at of to prescriptions the going to very It's the to the time X-year think of Eisai be treat first now probably it base not from LEQEMBI. We'll is with patients. our

hope as earlier. saying We benefit was And earlier, the AHEAD study. again, that a I to treating show with is to there

And certainly that patience. grow is that going the So to takes and where we're this With I marketplace. I to said as [ solid on to the It this a going only of evidence track. and in to we're go. base it's this building market of past the Lilly will I and market the grow. think quarter, entry accelerate is we're we're development ] seeing going is think difficult that I've say, very But doing, -- time predict

Thank you.

question, take Let's please. our next

Our Brian with Markets. Capital next from come Abrahams question RBC will

I Congrats the in specifically patient on persistence on here. Navin a little wanted seeing, a we're questions. you there. more rates potential and is that This seeing on thank for advance discontinuation taking ask about what bit Brian dynamic you're for to quarter, or our SKYCLARYS just good

efficacy away. you're of benefits to could to a Some doctors And more even patients the some educational as the perceptions of remain maybe to efforts speak well. little you there the taking therapy if patients if on bit safety that have and that right they're the the of seeing the and kind of not cardiac therapy convince on may

This for you Alisha. Thank right. the All is question.

see First, what every really I've we catch-up it see discons, at outside comes in compliance, not clinical now, into the We the are in look now start and what especially we're and times, population. and phase. identification And with we're very globally anything we're of from the when seeing metric mentioned to pleased the adherence, SKYCLARYS do before, right you trials. past was discon, as we patient U.S.

is not And what than saw so obviously in also trials. the discontinuation more anything we rate

really expect I good setting expect educational really think SKYCLARYS. of with both when the when good expectations what physicians field The materials have it on what to do been from you a job of product. this patients patients comes on teams patients, efficacy educating start to and also physicians with on to

tend has been and you're about you product it where saying how are do that good about adherence so physicians and And and good. actually what on very also is let's and going seeing we're least feeling we're to see at talk patients stay very on stay year, to a for patients

a of and is month see have the because and the phase, basis. this are the a additional we we week bit Chris we acquire every be in adding we're patients to that AI to data coated are little have with and we've physicians. didn't I regular going from week significant think we're And identification and on number even new what the to patient you We're difference more patients that at patients deploying, playing week. we're of seeing, month. beginning of at And even adding out them launch also every a because that are have their sharing engaging we we new to month single this was other to I least single been day, recently, dynamic could FA starting that's with engine identified other that see referring now you

them reach board. to And think it's new very more we promising able patients And parent across find as and the more to been with efficiency certainty with on. -- come we're so I now

Thanks, Alisha.

Next question please.

That will from be Stifel. Paul Matteis with

I around has I you minus commentary development on evolved times and the billion, recently, guess, year, think business think the said a I Biogen's over maybe $XX capacity HI-Bio just deal. couple of past more kind And of XXXX on of or transactions Biogen's of the like types going midterm, assets interest? what's appetite Reata the or or bigger updated areas in what's for forward thinking near therapeutic transaction? specific to

take I'll that Yes, one.

I I we're think we're first, in terms of where long looking, think neuroscience. already

outside we're of rare immunology, diseases. So that probably looking space,

would Biogen, and I within scientific at the we As say I company. capability an medical extremely have high look

historically is really the for products necessity patients in through provide company in physicians area. evidence been a extremely testing, have studies reimbursement thinking get this. genetic that volume, and expensive to the sponsor for a understand and low real-world example, to about assist important We We high-value some becomes

with since in we've So multiple in diseases. we rare been Biogen really I area started is think sclerosis. capability there's of a Immunology an

think the we have those to I areas. So capabilities go into

I company that It's where the we are find find we're for But Reata that. think a rare we rarely. I a that we on you pattern. think type those If another look that growth could close now pretty along can is to acquisition, market. is come would

value. In creates already that acquired time the that, but price, had fact, it's shareholder actually launched it for still acquire we by

continue a along deal. do to a position will desperate day. And we're don't we but every look, to where they come think not we in are And I

if for example, XXXX to why And more I the we've at frame alternative picky. process. launch on we the for XXXX So we mid- done as think to able late-stage look is that's development time of focused in be products -- what to But to you an we're also with HI-Bio, can us. priority really that, a being sort

looking create enter think you where where if don't also I everybody we into else not auction is processes. necessarily look these you is really value

player I think really able overpaying. this a will really can a a so space avoid by where to think And areas to we -- is be Biogen strong is where stick those being this

other billion company. a a thing lot bigger companies doesn't where I is $X size. needle. the needle the is our of hugely I billion say in moves nice $X think the are move would There Biogen

smaller be where And so capital the players be might think look the assets some I we of too we bigger small for players. too expensive that some but at have can for

in competitive we're necessarily can where your we ways, some and places in in think look I such for be a where, overpaying. not So again, assets position risk

there's systematic to is that, going But sudden looking. we're take I'm Biogen. for of a that's terms We sure where we're view sweet think a out there. because just spot number the not any left I But not strategically take opportunities really do

are also see the in to And lot a on We think doing really from do like us shareholder more lot can of more research create. can acquire these assets things collaborations. bring value in the I I'd assets more one you because an the a stage earlier early you is

Chris. Thanks

please. question Next

Michael Yes. Yee be with That will Jefferies. from

looked that et to Can to I looking Earlier data, forward portfolio, lupus cetera, bigger and are a in We've just What that treatment What do reasons commented prior an call, the at speak et you you your data. longer believe you help for? about lupus cetera? to expectations? emerging needs there some you happen know move upcoming and have could here. study are the to

is This Yes. Thank Priya you. Singhal.

[ So ] is place. in ]. a a are the in next several readout very is we [ upcoming good DAP excited overall, weeks. partnered This for collaboration program It is about the

headline SLE very Phase specifically, high the of add We disease standard want are to as efficacy to on top standard SLE global results as is first trial. be versus in therapy an clear a And to safety this line that I area, DAP the III investigating add-on and placebo unmet expecting on therapy. of study an this

II by standard We to to bilag-based of week and care we Bitla, . I the weeks or place effect. long-term despite conducting in lupus but -- the than study, demonstrate Phase or the the study be composite it flaring will at will frequent and have patients similar very who different looking II, efficacy take active Phase Phase XX stable are assessment assessed over the persistent

safety meaningful worsening. activity. we without moderate ultimately, or we'll requires body improvement clinically really disease [indiscernible] looking increased composite baseline patients all symptoms the secondaries And well flare primary size We steroids activity in severe endpoint disease as for a and background medications across meaningful key to provide substantial or that a set need dose SLE other think change for with on be a as and for without prevention, and also such low on the sensitive as escalation efficacy. that activity the sample severe Eventually, achieving data

So this patients for could addition this profile, we're suffering looking SLE. think safety tolerability forward to really to be meaningful we in an acceptable and from

the another right risk we to point, if now. have at results warrant So this we continuing the are but Phase need III, expect of development, planning run this some to at

Thanks Priya.

please. question Next

now Eric move to with Cantor we'll Fitzgerald. Schmidt Yes,

that relatively that your in a watermark for all this certainly Chris, accomplished prepared that call Maybe tenure of today to now place as some and you've in called high seems the remarks. your are CEO, be you like initiatives out given well and in

and you're that got called done. you've You some out not challenges also

mind of top is particular in what So there?

hope Well, thanks mark not I water higher much for the aiming here, we're you. question. it's can I would the because tell high

franchise clearly, still got -- competitive of yet is MS TYSABRI. biosimilar in done seeing the an threats. There's not a think we're terms we've that I potentially for

chop for of term, an litigation But there's we think have opportunity so I water. market always fall in We is Europe, an an in patent talent that exclusivity have that is see in TECFIDERA have there important the Biogen. expires amazing we'll February shorter in base where and the the we inside

in that in continue the medical to impressed and have the just and a by this we been of a got capability lot I I've business seen capital. know, we've all you long companies. company, be As scientific time,

bring things we I busy do innovative capital. review products that X to passive We vouchers We've products nature the is we with of we of market don't really into that innovative transforming essentially been smart so shelf. Biogen's had can the think anyway. capital capital. vouchers active And sitting priority The those need on because such

voucher we that We but sold an half. now we've look on X sitting for had milestones into hopefully acquisition Growth the spend growth and the asset. into to this able X.X business out objective trajectory in converted on opportunity If see took one that is so of active of priority to think we savings development HI-Bio I years at it, years Fit Bio, for of So second the HI- review us shelf transform of and the I company. where that operating expense I been is with a we've change the the

to do results. the people able We've business been got release I we've intelligently. and them great think And can that from that reinvest with tremendous resources

the our now both we're going R&D portfolio, externally. I So it's sure and not future, that to look really investing like future, really still innovation out forward that. I'd we the in we company building internally are an just acquiring towards think but as make

I focused think to the XXXX frame. now on I'm XXXX So time

I think grow we're good through in that period. shape to

we continue into do see lot and active with I be us discipline, think really in into capital to then turn capital and think a But to growth. R&D of I can able to capital passive the think more but deploy active capability you'll I take of advantage

any additional Right. for remain us you, today. you, questions. IR Chris, Thank and thank Thank joining available you. team will for everybody,

today's that again, all once you thank We your conference. does for And participation. conclude

may now disconnect. You