on team, Head our to welcoming morning, Chuck. Chuck Thank Great by as the start you Relations. Investor Good first you, Chuck. have of new everybody. I'll Triano
think business see we those made slide priorities we five against for the that I priorities. a the during our last first described first of lot progress five quarter, On good you call, here. And on the
to Zuranolone both in LEQEMBI PPD. continuing MDD Alzheimer's potential the work in are disease and and We toward launches of
slide next some because priority. the on a super that cover to ways in it's going I'm And really
R&D, of Priya -- improve see R&D the On point productivity improving next take the the the detail. review on of to will and greater of risk the profile and you'll steps productivity in that to risk profile taking
on a going I'm to bit cover more little cost base. the So
thing is made The progress those -- dollars that on I'd to of been that been That say is savings. complete. first have like had previous good program billion have a that secured we've program the announced -- and cost dollars billion
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And so refer additional revenue an the expected align while operations internally this leaving fit-for-growth. program we base we've the upcoming money our launches. initiated And to with as and enough program for to cost
and opportunity the in that balance competitors. we're to to projects we that looks with an to attempt by cost our launches little R&D profitable growth back in to something bit a what really get And investing and with is our the that that product priority base trying more deem do reduce for try line
do taking Now costs. really is just the out What of job simple we're that's to company. a redesign not trying
we're launch clearly US. the Zuranolone focused of the going the They're certainly points in is instance. And won't launches. We different two in going few priority in years start. be outside top have first of Zuranolone for the to outside US. focus LEQEMBI the on these We a short-term geographic have have at US, the to the
company the has don't we to the make we good of lose things do is that in sure been what one what and working. want So is
We our patients There upon treat have sclerosis. who and are that have information. of to depend we lot remember have still also adequate patients multiple who the are products those physicians in we leader make a to sure that
there supporting a our act growth the tried is resources we MS to shift historic opportunities while our as behind balancing So business. still
SPINRAZA. we're point And so -- been multiple model. a with a to essentially bottoms-up this. had awful centralized to And products a and cost. sclerosis a result, years This approach our a had much operating at we in we obviously methodical we and could product have profile. some hemophilia an lot as one taking limited We've of Yes, in a approach different XX have
now, our looking attention closer more get to customer. the our do how we Right a of lot at we're resource and
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is opportunity about an be are that we for we there more at transformational something reduce the recognize in company that sets looking that cost, really up We'll really able say but to So, do to QX. growth. more
priority base in dynamics managing Another two is really company. business. the the There's
that business growth affected increasingly by Zuranolone. have but competition. with and MS, we And in LEQEMBI opportunities leader a is are We
a So in did favourable that until European year. to can. manage property patent Justice will a on enforce as of and this intellectual Union XXXX to least and exclusivity also related decision the TECFIDERA how marketing we And important protection February an reinforcement of We enforce settle. it TECFIDERA continue to time receive as we business, provides the the at next us EU. but marketing was the we from idea And is protection, believe take for market profitably the little protection, business which are base regulatory we do to separately, of data the for our that rights. looking of We Court
of aim MS all to now, at defend the goal the looking Up to until the revenue profitability we're been has maximize to -- to franchise. cost. looking also We're
our look a means of resources align that at to where property, think promoting and are other I do sales MS, want where still a sensitivity and we we that of little products little do the with nuanced where perhaps have now to take of we less approach looking opportunities a expensive. more promotion have tried in bit intellectual at
patients gene We do has there therapy and that still can we And that SMA options suffer to for oral the quarter, at are and quite believe everyone. the any do a stabilization has in our from not biosimilars growth And announced limits SPINRAZA don't for seeing to few we previous therapy from formal benefit we that marketplace, up are its strategic return have the there treatment. as a underway evaluate business. process
think launch opportunity we that is for the this business is important especially make business manage very and and help a who way system how seeing healthcare -- Humira, biosimilars need I economies an the owner fund to think might the to we are to of best business. who innovation This about the for with that good best and be is and the of
an which Tofersen. in I MS, think, been On its bit migrate experience as could growth a has external pipeline. from SPINRAZA, It at is past, with more One perspectives. with we that we're I've with neuroscience With diseases be in of I into disease, two think Zuranolone. we reinforced think external focused. we're looking little really is we basically But will on how and argued And, growth, immunology. autoimmune course, an the company in balance neuropsychiatry very rare do I have the
results and do making coming is, the this no, MS a we of opportunities growth slightly dynamic smooth external to possible some from that that as a I So at there point may is out how of build Yeah, think transition way these did declining franchise new of look growth about franchises. of describe offer as and we as those sure view.
Development. And pharma Biotech. across I'm that have and say Keeney years he large the has just of of experience, also XX in and strategy pleased R&D was Corporate business in CEO Adam appointed our to of Adam Head we development, not both a but over as
as So I some major got see I at want growth think diversified revenue, LEQEMBI We that development about trajectory said. we support very but and entrepreneurial to spirit business contributors continue will as think to Biogen. do and the he's to be to welcomed Zuranolone
have could next I the slide if please. So
unprecedented really So opportunity. we got an
We Tofersen. a have PDUFA for date today
going neurologist, many and but date area significant a opportunity. a are about in it's Obviously, we areas. be an August different much there's to done capabilities be to PDUFA course, on said think that. We a on into franchise. and have of for to in is PDUFA much These that LEQEMBI But lot different Zuranolone. market for launch. still a another home, since biopharmaceutical little building That's earlier, a of different there. of can't I huge Zuranolone has have new to date I July as have awful closer think to takes that major us position company products And, LEQEMBI will we
approval of back of is These Health and quite China. dossiers that EU, reimburse and that really at of congratulate US priority in Eisai a this filing have Administration accelerated have significant received and has same approval decided major milestone to effort. our But US, initiated filings We we're making the Japan our I China. for filed and those traditional in in colleagues in within in US January. review milestones. And, Eisai the LEQEMBI. all timeframe received to Filing course, kind Veterans for on in day the Japan the regulatory in We the
first Now, the July. is in to hopefully anti-amyloid receive be globally LEQEMBI approval going antibody traditional to
busy, approval date for scans, be complex is bi-weekly imaging, MRI issue major we received the which launch, puncture infusion. we it's full July. answer that PDUFA this As to milestone, already a said, on amyloid we in as specialists product know an not PET the straightforward expect reimbursement capacity be CMS are following expected the once confirmation, a diagnosis could initially. who an involving next will has have And lumbar
CMS at Eisai about both those actually More reduce but for is make we already be pursuing capacity expand importantly I've thinking we can patients the over in subcu formulation. what do are bottlenecks. Yes, And past, Blood-based are though, to going and we that cost. meet is maintenance to right now really we to do need. in alleviate Biogen there, going said how this to companies are are the in time, easier believe as and a game-changer space. this the diagnostics, dosing looking
patient that ADUHELM support. For advocacy a and a would American are this is of a lot to that The is more Association I have groups active getting has just question, And are support that important compared this that certainly reimbursement, situation ensuring therapy. know in Association we faced, helpful. Congress. access patients number Veterans' of the to out I big point the written from Neurologist
responsible of and CMS hope coming is coverage CMS the under contract out with broad Eisai for decision. to So see engaging the we would
are is think lot a Unfortunately, that it an those of medicines market. of a are older Zuranolone large Now I'd medicines The is Zuranolone like so just the to with still and There to clearly minutes. main for suffered the our talk side them people underestimated problem takes few for depression, portfolio. are I it in of available. effects of a number about I mean, a those asset work. length time from
And days Zuranolone treatment was Zithromax. to launch that works be three that different because find similar a works I weeks. we're and it's talking of about is analogue in can way a only two potentially type going The in a in
for do need physicians chronic some we there that on So basis. a treating used know are is to to be going education,
different launch we have to going we're to metrics. As about think even,
is One TRxs. be of going that. TRxs see we're product. the Well, when the for with the to look launch you not to going switched to the in are NRxs They not things that
paradigm physician in good shift changes always these behaviour. pharmaceutical This we are there and marketing know. a as paradigm in not is a shift think thing I is So
And really for a the that, well, product freedom that that is product what two can taking stop of patients. This that it about really it's difference fast. a think after this efficacious, works Zuranolone. a is drives However, weeks you us, knowing makes
it So enormous Tofersen be obviously, just opportunity. going big patients. product that I'll it's with I this, is a is not finish to classic about XXX Biogen. think And an on But
biomarker adapt has a to ability long is the a was be -- of a There setbacks. a with and as relevant in ALS, at scientific disorders. huge able learn to is a history and But neuromuscular we an help organization partner deal to community to ALS. will neurofilament Biogen who are because neurofilament have This in the lot characterize looking researchers of lot
has Biogen to after got that unmet science that the need is had to lot I think everybody do. in significant been a where So resolved things this a has here. we've -- some resilience ground-breaking of able go way not And has
should a Next got hopefully successfully. LEQEMBI. a number have US. the as By different slide, and expect of coming, milestones here traditional on with CMS behind in We QX place broader if call, we've be date approval can in a coverage you I could. to us the see the we We've would our received Hopefully, slide. PDUFA
be of first the having end and we'll of fit-for-growth launch. our communicating in course, and the year, we've By hopefully for scheduling PPD three-month hopefully program. the got the and we'll as both of And, MDD cost about in more optimization Japan initiated approval have a approval received DEA completed this LEQEMBI ex-US period as well Zuranolone
look which expected could We we'll on evolving administration. take further with would of the course, -- LEQEMBI of LEQEMBI Europe And, for I expect time by with footprint at-home filings I the the build China. disease filing -- to opportunity the steps time paradigm also year, regulatory Alzheimer's an if And global facilitate end and dosing. next have maintenance ahead next think by in of we dosing, an a with approvals treatment this regulatory subcutaneous of
combination sign, opportunities high-potential diligent conclusion, and breaking commercial ground near-term in capital So of through allocation. a of
well-positioned long-term Biogen is the going think I to for be sustainable growth.
now over update to Priya for like turn an on it to progress R&D. I'd in our
