TAK - Earnings call transcript Q1 2022 | Takeda Pharmaceutical Company Limited

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Christopher O'Reilly

Thank you very much for your participation in the conference call for the financial results for Q1 fiscal year 2021. My name is Christopher O'Reilly, Global Head of Investor Relations.

First, I'd like to explain the language setting. At the bottom of the Zoom window, there is a language button. If we want to listen to Japanese, please select Japanese.

listen please to English. want you to select English, If the to please Or want to original if you listen language, off. turn it

Before Act those of discussed everyone remind Actual results statements of like The materially be XXXX. Private I'd from differ the Reform forward-looking meaning within factors that Litigation Securities today. may discussing the notice starting, we'll that in other Form important recent in our Page the SEC to could Please on XX-F cause refer our actual the results to of most differ materially are also filings. presentation. discussed X and the to

Julie let Now Ramona Officer; Affairs; Christophe would Andy President, Unit. session. Masato a CEO; introduce Plump; presentation Kim, Business Costa. Andy please the with President President, General Japan have Commercialization; Sequeira, me like start panel. President today's presenters R&D Christophe, that, Therapies Financial I followed by by question-and-answer After Iwasaki, Weber, U.S. and and Costa Plasma-Derived Global Business the will to Chief we Saroukos, and and Unit Portfolio

Now the we presentations. start

Christophe Weber

Thank here. year this inflection our revenue you, as the in in know, very nutshell, slide, we an If is and please. dynamic you Weber an go first can a Thank Christophe earning results. momentum. attending What QX you for for -- of much Takeda, year inflection It's Chris. year to terms

is the which this pipeline. growth what Our QX, inflection an great we -- will accelerate the in is year. exactly And during seeing also with our start XXXX. year It's are of in a

in brands, to to really forward grew X.X%, continue and XX driven growth we our revenue by are global Our our accelerate looking XXXX.

the is seen Japan, Again, vaccines facilitate, Moderna in have to our that and bring partnership dose the very Japan. you active COVID-XX with help also of have million to the XXX are to expanded Moderna with we will vaccination. in vaccine We

in topline growth. start an in year Overall, An product. of our good approval. starting acceleration It's the variability terms we year pipeline. with are of in momentum, terms topline a also spite submission with the of product of of year and important So some by inflection very

You designation for X It's in weeks, X very saw we aiming also innovative our breakthrough U.S. status a a pipeline. that in product demonstration are the a got that last the of

the as well as got designation breakthrough TAK-XXX So status TAK-XXX.

continuing development in the Japan We are also the of approval of vaccine with year. in the second with Novavax potential part the a

much are focusing with the as we vaccines, seen will the dengue dengue with The have you it to continue and which did the instead well development partnership we norovirus Zika. that fully On of very our partner vaccines, COVID-XX by a as is our on and investment the COVID-XX doing but ourselves and focus, is just of required. capital a

nutshell, the now very top will situation much. both further And good our our regarding for on explain momentum and pipeline. a in the the So on Thank line QX, pipeline. Andy very you

Andrew Plump

this you and you turn Three presentation Thank morning. much, video everybody, Christophe. to video If I'm my trying very very on. good my and Great. themes to could essentially -- evening, Well, thank Christophe. great. much, someone turn my on

are is predictably. very that on a and pipeline, first and The delivering and we our on pipeline to we XXX% have dynamic deliver very ability exciting sharpening focused

brands, this R&D significant story for the our is, success And or the that's a great of science, year pipeline pipeline for see thirdly, inflection. said, global follow we just whether as Secondly, a of Christophe for our you'll example ENTYVIO. and then

early coming major this up We year. and year of next expect rest the milestones over into

this brands. submitted marketed the judge and the front you EMA. see candidates, with excited, middle in In over announcement. the we're you card, the our late timeline, and next it lead into is And essence, marketed next go events report of row, the ourselves our slide, our you development our the year. Orexin we that really all showing but GI course products up year. you to global go medicines areas slide slide the what see our earnings we're quite slide, this in proof-of-concept and/or for be broken I'm genetics or for QX please. of how This importantly, year success the our can in progress course see in and all too for any other for had it's for the of have fiscal the the in inflections potential continues date of up make to dive In very throughout chronology this last franchise, very at therapeutic expecting rare and of oncology, There -- the in a focus, to in that a milestones do, we've TAK-XXX. going for includes that into year. our out become the then is pipeline X These complex, of that into set May to to We major us hematology, we're patients very submissions, expected all chronology the next will U.S. Above similar put dive bottom with setting, not can our slide, into we I see to year it's momentum been the is will and will to the molecule the not fiscal go you a this the pipeline across here and the are And that in significant, next our if which X brands meaningful list fiscal making of major X we detail. into visual So please. accomplishments the particular major and this if started of though, XXXX a over our appendix. of events future. bucket, a approvals which that X just the to inflections expected on we year, submissions the beginning you our the for buckets. And major that that

alluded has a some deeper already just interactions, let's and very So do these, Christophe to with start dive. just and of regulatory I'll significant

of Firstly, about the very approval mRNA Japan. the in Moderna COVID excited vaccine

I'll respect you approvals In had then submission we're addition, China. And Japan very for we in and And Both in for currently. discussions China, review, the We're we're these looking significant have in United agents FDA the X we're and in mobocertinib and both our have between just globally which forward both our EU our X and to -- with portfolio on filed approvals in forward focused very engaged and for Japan a future. second. global With the expanding China States. in global ENTYVIO, priority pipeline, to know, into brands. as X thirdly, mention a Wave in potential maribavir X not-too-distant Japan been of looking

with was a accelerated of is we've in . greatest accelerated we We're on still We've with still TAK-XXX, and initially to also and majority vaccine. the assessment. As as breakthrough the The this energy our X are dengue programs been TAK-XXX vaccine And pipeline. That's and value submitted half strategically submitted About will our a to mentioned, quite initially opinion fiscal X convert, both an and applications accepted prioritize an are common. that drive X Wave are then expecting year. made our designations. X We're process vast EMA our pipeline, as big accepted, as those making aligned they're and decisions Christophe our of dengue for converted lastly, our CHMP designated attention with this if actually research in focus that our assessment. investments had, these pipeline approval. the designated week to and standard decisions that's most This by you Wave Takeda. events on know, and a Wave just pipeline

costs And for maintain secondly, with economic next redirect programs, X X on If financial that these significant we these from partners, so we very can our very attention found programs. there still burden, is very significant just in operational these And but I'd our the to obligations to go There's not that partnerships also from ourselves remove our slide, And priorities. so and by are One for we exciting programs. we programs. like finding of points the upside we please. highlight. potential

walk new for indication Europe a in we're Let through ENTYVIO. me pursuing that you just

very was was high this About colectomy. a medical is brief multicentered with a is antibiotics. of Phase fact patients as as It pouch XX% trial. inflammatory is a trial antibiotic-refractory XXXX, was So will develop will Takeda-sponsored XX% care, very we an What of have And a placebo-controlled, the condition as but in just quality the conducted to as pouchitis. patients was known very that? a It these high standards, interesting undergone existing trial. story. antibiotic-refractory the individuals, pouchitis, colitis undergo was unmet a percentage, then which ulcerative XX% who an initiated pouchitis. double-blind, condition as Well, highest known much It's XX% formation that what's of IV with anatomical as refractory predominantly standards colectomy that to is of known trial in The become randomized, of study And it need. story a known EARNEST.

So in even cases, this some can and patients for be quite worrisome fatal.

study. study, striking a ran saw we high-quality this results. So we and It was

We're beyond of over with it and but consistent the benefits of primary, well secondary of say, the clinical ENTYVIO suffice we can say it to including In endpoints that to highly remission all significant. multiple in standard XX% our with endpoints, -- our present not presenting secondary our you major these suffice fact, were care, see continued XX. lower right, XX% week under with will

the would under we Phase high and has that's risks. getting didn't of a those dossier endpoints review. but the validated That EMA Given a a registration a is the There what review. the data, submit this to have submission under robustness it's agreement And we and which decision We and think are some It single was unmet medical there's that EMA. for on indication. look good with like. made now study, at study, labeled means IV the been shot accepted to need these

exciting please, So over if the next slide, slide. hand a pipeline. it to our to really and I'll just Chris, last before for time we end I go that emphasizing just it's Costa, just

you. it's dynamic, I to it's it is deliver value. over hand really to pipeline Our that, With Costa, and will starting moving

Constantine Saroukos

video and up Andy, the hello, I'm coming up, just for now. you, waiting everyone. come Thank to Okay. just

So Great. you Andy. so thank much,

growth. year fiscal our XXXX, mid-single-digit acceleration we full Christophe track X underlying guidance, slide, year topline in in solid and started to of the towards quarter a are say format, highlighted our opening pivoting As towards full year growth. off his And we I'm pleased from revenue we're on that

underlying such portfolio diabetes our in divestiture and in Japan, not was Reported track XX.X%, momentum, going exchange year phasing X.X%, from X quarterly growth which some portfolio quarter the the has to this revenue. Firstly, of topline. for revenue foreign both were was TAKHZYRO core business we to delivering that and and forward, growth although benefiting favorable our on note on sale the our as the and Please offsetting been from the headwinds. at sale the Underlying positive headwinds would immunoglobulin there products products, see are revenue guidance. expect full excluded

from where contribution last new strong approvals had saw China, year. also this -- X we We

target grew margin ¥XXX.X to approximately we billion a core investment. on and towards debt full the and due on delivered end XX.X% payment deliver well portfolio, ¥XXX profitability. out R&D the as regards flow, our Reported and ¥XXX towards X, so, on pleased we Maverick. USD profit With cash our we're quarter of the while increase of we're are XX.X%. dividend our year summary, reflecting at half focus slight guidance. the of flow for solid diabetes declined remain In first benefit acquisition to performance quarter billion, the XXXX Net at divestitures year free sale Japanese delivering X.Xx, cash EBITDA track profit from as of still adjusted billion from in firmly the Even X.X with in Moving a track very we to the on or full of XX.X%, margins and of to to a cash our including our operating delivered billion. operating increase we in start, able March, year is as to

Next please, Chris. slide,

Slide results. summary fiscal of quarter So our X 'XX is XX year a

operating in significant adjusts with was This portfolio. year. ¥XXX.X which the quarterly of and due profit was investment, core Reported was ¥XXX.X So of ¥XXX operating impact, X.X% grew was ¥XXX.X increase billion, R&D of of further billion sales flow momentum billion cash underlying we core revenue as a Reported mainly of growth cash of operating of exchange flow a out the which securities X.X%. underlying mainly was profit growth up quarter with versus offset divestitures, ¥XXX.X growth with foreign XX.X% the billion versus result divestitures, to investment as foreign predominantly revenue phasing which down in were Underlying profit and the Japan XXX.X% adjust of prior our divestitures. billion, from investment. and ¥XXX XX.X%, EPS gain XX R&D year. growth into due offset XX.X% to the core sale growth, operating the and exchange R&D X.X%. its integration with fiscal of for diabetes onetime reported the the as booked than reflection was of as growth revenue Japan Despite EPS decline the year, due as operating in tax the cash divestitures. to year Slide and flow revenue ¥XXX.X increased is the insight price lower Underlying of purchase was XX.X% foreign and impact And EPS portfolio year well up sale Operating of X adjust prior the dynamic. revenue, costs. XXXX. was This core X.X%, by versus business our billion, Core was prior the more ¥XXX. If favorable decline diabetes was core increase XX%. impact our was XX.X% our versus more billion. was over exchange of accounting Core profit a gives of marketable free and prior margins at out both higher ¥XXX.X a

right, you reported see in left So billion. core revenue was XXXX, can our X moving to quarter from ¥XXX.X and

minus driven we global You exchange. percentage predominantly we momentum points, growth had by X.X underlying brands. of in underlying our foreign Divestiture also -- saw XX X.X%, can was see, favorability but momentum headwinds some

revenue was growth So that net-net, the portfolio is a Japan core our of Thank the ¥XXX XX.X%. growth sale diabetes to revenue of billion X.X%. us Adding of you. gets

X%, Next is by with key year growth X in -- It remain Oncology XX higher stay-at-home It slide, decline COVID-XX now we impacted, shows on This areas, diseases is after strongly XX% on revenue QX immunoglobulin was talks X% business also impacted down rare of slightly total impacted by portfolio. X% and which impacted and moving is slide immunology impacted about impacted expected, down of areas. hematology, X key we by to represents please. mentioned, It by our PDT our phasing. that HAE growth. rebounding business also noncore our Slide focused prior ENTYVIO, revenue, some at to of and phasing X/X of was increased which XX%. by of revenue. grew which for from execution some last GI, of restrictions. This asset represents by has our spearheaded fluctuations as continued of as divestitures. quarterly result quarter-on-quarter as year. XX% our full grew TAKHZYRO, of returned VYVANSE growth, X% which XXXX neuroscience X% our year being approximately and Rare our at total delivered a the

Finally, I'd your right-hand the other. like the to to -- side attention draw of or

declining you can saw growth of the Here, assets, assets, the some XX we Moderna to that book X the in same which in the divested were did we X. for at This quarter quarter is Slide noncore see predominantly we X%. by vaccine fact ¥XXX.X or at time, underlying many Japan areas. due within X in the revenue quarter some these In red maximizing by indicated global our billion XX products billion X brands particular, on an generated focused symbol. the main key on are here in products USD In and revenue X.X% shows total, globe grew our we business basis. our and of

was As declining mentioned slide, I almost quarterly immunoglobulin on the phasing, by previous impacted X%.

full also XX%. we our guidance X%, for XX% remain the remain to for growth quarter again, in But phasing a to strong of quarters, recover on this confident due of impacted Quarterly TAKHZYRO, grew our XX% that mainly maintain will anywhere we X% forecast full prior the the However, year. to which between growth we in coming year and year.

Moving bridge the which operating from Slide now core XX, to profit. to shows reported

important price to the gain sale declining or of on operating purchase price really the and reflects note our what's the costs, adjusted allocation diabetes portfolio Here, the is, reported integration and then profit purchase are accounting out of which core.

and very X, similar, ¥XXX.X our profit So you this quarter are reported for is core billion. core reported ¥XXX.X operating the see and billion can

Next slide, year. profit factors operating our core impacting of prior please. our impact shows growth versus QX This our --

business gray the the excluding investment As R&D was of the you as underlying see impact dark positive in foreign bars, our exchange. from was can ramp-up

by was divestitures. to in support the as as the our red X the impacted R&D pipeline, growth as the the the by However, sizable innovative this year, middle, shown step-up year-on-year bars is as significant from impact investment a in inflection well

resulted ¥XXX X our core Just because divestiture, easing remind factors X position demonstrates in margins. year everyone, achieving our profit operating our X our a impact commitment March see in strong of XX which last quarter us to impact off to to towards X quarter we ¥XXX.X XXXX the Slide overall year in year billion, we These from billion. expect this to of forecast this full products. of puts divested quarter XXXX,

X of Here, And much on closed we underlying target. with see again, was of ahead our very we're XX.X%. slightly you margin delivering year can year operating guidance profit to Quarter XX%. core we're full our full the approximately with to track XXXX, year In XX.X%. committed

please. slide, Next

Free ¥XXX.X of balance cash ¥XXX.X quarter. in was and cash want the flow portfolio, sales the Here litigation by was reflecting X the of quarter phasing cash lack over capital. some diabetes Slide billion, flow and the towards working asset Operating billion. now, the Japan and our settlement from This the year. of cash in includes evolution ¥XX.X cash billion flow offset to cash shows this flow, switch we CapEx XX significant first

year Our net paid Slide quarter the X.Xx. other debt balance, is cash billion with prepayments EBITDA to for X. dividend on the just cash balance but quarter the also ended adjusted to payout payout as out the quarter this We to in at ¥XXX.X a Maverick made bump, June you, evolution bump net remind including of with the items, It's well half debt slight the half in reflects XX a debt as in plots Maverick. acquisition. dividend reflecting significant X, coupled year due

We expect to the in snapshot decline X XXXX, debt where ladder. fiscal quarter you your onwards. paid of the XXXX, I'd is on off was to the billion can $X net debt obligations due And aggressively EBITDA maturity year adjusted full our to we in latest debt draw Slide like to from of top for XXXX. that see year attention quarter that, a X. fiscal of have prepayment made already XX been

already, that due So $X was million made year fiscal $XXX in billion the XXXX. we plus

in billion prepayment X.X for what is, bonds, which for a expect EUR So in make we payment we see August, to we July. called

in we actual paid year fiscal expect $X.X approximately So billion in of prepayments total, XXXX.

year approximately As debt you'll in see result, ¥XXX what will obligation 'XX, a billion. be our fiscal

from pay generate down cash and rapidly we'll year end to the So the way XXXX will future allow X debt. to us fiscal accelerate that continue to all of quarter

please. slide, Next

Slide to now XX. moving So

mentioned, underlying despite to already of the to the Moderna Topline, on -- we based year, that digit track, to it's finally, and guidance and important some We by of of start in X.X% are we're our phasing Japan. the We're grew our Slide note global an to XX communicated emphasize the quarter confirming that and continued full guidance. May deliver accelerating at in Last X.X%. seeing to to year at track X I global X, quarter revenue brands we year XX, the changes year of our during like on full with rollout we to we're also solid in mid-single as accelerating some earnings. our XX no vaccine the that acceleration. X% X.X%, acceleration expect spurred But And targets in we're to on also the by driven I'd that here brands. are deliver XXXX

XXXX ¥XXX 'XX it to continuing started mid-XXs. midterm, to well We Q&A. the for guidance year we're between margins, for our confident ¥XXX to billion that to anywhere billion at We're Our profit, off on I the cash we deliver anywhere XXXX. Instructions]. [Operator by target your billion. debt operating up low adjusted heavily to see improve ratios you And focus XX.X%. between free flow on track in to And net EBITDA Xx and to XXs Thank low cash the our ourselves Operator. finally, our our to open fiscal for for flow. ¥XXX to free attention, and will continue deliver

The is Citi. Yamaguchi-san first with speaker

Hidemaru Yamaguchi

Can you me? hear

Christophe Weber

Yes, can we you. hear

Hidemaru Yamaguchi

Citi. Yamaguchi questions from upfront. Two

factory. The first question is Hikari regarding

the think July. happen in inspection should FDA day of I Today last July. the is

inspection So have, the give on warning and question update any factory first letter, the you the the Hikari as me, FDA? that's prospect -- That's can also inspection on well, the question. future you from first if

Second Phase use BTD opportunity can of Not that got that Phase shorten a congratulations remind to drug? or XXX, Phase it or BTD on to the but Takeda IIb, some timing for does II the either the saw efficacy designation? I, efficacy in data, if question is And see launching clinical already But that potential can FDA data? through efficacy the trial which -- is exciting. mean you you the BTD, me, this is those also, future

Christophe Weber

Thank the you, Andy first question. and will the take Yamaguchi-san. second It's take Christophe here. question, I'll

to remediate this -- and later. remember we progressed the the a to finding we that asked So the associated that yes, because for reinspection requirements, warning met we we lot felt we

course, all very the inspection So inspection could in because, happen. the and do of July. but quarantine the of was environment, complicated this pleased that FDA did are we It the

finding, inspection with has because and but of pleased very that could it are happened as as the are for we write And soon will happen. as pleased to the will event I it it we report outcome takes with good to we So and we cannot the we can, conclude, us, the that. tell disclose very we was that. it a but time you asked,

Andrew Plump

Christophe, I FDA XXX the question. maybe take

Yamaguchi-san, much the for thank So you question. very

seen part question absolutely, FDA So the first your study data of the answer from is, to TAK-XXX-XXXX A. the Part have

that it's externally study, have we've because in the alluded but breakthrough the And allocated the study. results and FDA for asked we that that of a broadly about designation an by With shared To case, is very haven't ongoing clear, to the significance acceleration. seen narcolepsy. robustness this we So be X indication. excessive it's you particular in regard typically second daytime sleepiness question, type for your to the

So base accelerated. hyper this our program is plan for already

dialogue only XXXX. November with molecule a -- in for and designation this still So of have further FDA. tracking our submitted and lead clinic very and into iterative breakthrough enables a in potentially have privileged incredible is designation and expected approved opportunity to to base allow which acceleration. that could this went we're TAK-XXX is Having XXXX case, on, breakthrough an the The the

So when waiting not a get in you're up, key front them. to months of issue comes

working You who very with. closely have you're individuals

you, that affirmation accelerate gives an data it an it's of further, So yes. opportunity to even us to shared the we've look with and

Operator

question Stacy Cowen. Ku is next So from

Stacy Ku

progress A Stacy from Congratulations the few the Cowen. in all Ku on questions. quarter.

the of question second ORLADEYO Any half the going didn't launch TAKHZYRO? in That's to And launch is launch question. from J&J Can updated any And too ahead first, BioCryst's now impact PDUFA a mobocertinib. their the about the earnings RYBREVANT. speak looking at thoughts their and nearly much year about release, preparation you So implications for date? prophylaxis around be first the with on market. talk they latest commercial

on What you you So end? what are are seeing seeing?

Christophe Weber

you take could first Ramona, the question?

Ramona Sequeira

you right please in jump I'll that okay, are hear you assuming if -- TAKHZYRO, but I'm me know can Chris, not. me Yes. with then let

being look So much confident achieve with question, phasing, but for said goal. to . driven expansion. thank our TAKHZYRO, very for that quarter X be to is we're in by very going confident was as year year We so this XX% growth projections we Really, TAKHZYRO in your the due largely XX% full year to to and able through the Stacy. you geographic TAKHZYRO.

penetrated prophy in markets growth the of to deeply we're see we've into we but market. do pulling So U.S., continuing launch pretty U.S. In the a the the market, outside

believe prophy we time, the we happening continue that help well so only market still over recovery to grow obviously, prophy in And is the continues the COVID will in to that And TAKHZYRO U.S. as and grow.

we as upside the ORLADEYO COVID has seeing that too, to an and there, Certainly, in So continues think underlying business. recovery U.S. some happen, there's impact we're of the made

TAKHZYRO might I which from even have to It the a competitors that what and to for patients that it extension TAKHZYRO, strong We've certainly, position released data is efficacy. options which rely have we have in hear And people to of patients, ready good of truly it's TAKHZYRO, switched our having being and to to stress without think us our to are it's just attack. as that people makes good that very for and And sure back company. ourselves strength, us HAE to anxiety our impact. a keeps we I on the toes and to and sort trial, think that's longer-term efficacy continue we live switched to on. continue continued have the that HELP see from the for something shows allows then an feature continue

to grow now. based COVID our with of ability the market recovery, we're growth, brand expansion, geographic the right with strength the confident on both our prophy in the So with

Christophe Weber

regarding question your for Stacy, you, mobocertinib. Thank

and is area is progression product new are type focusing for, the stress and that I pipeline thing looking one of are about are we on launch aiming to out very want that we for the much with So inflation one we working colleagues R&D products, is that heading being much our and of ready. our And on And commercial global businesses. the focusing our other Teresa the closely for very leading launch with oncology. all Bitetti Ramona very is oncology the regional preparation -- unit was business

to So be it know when a and to -- major have because And you launch, much be product, but very ready opportunity can't product guarantee challenge our you, to approved, will I is that focus. a for we ready. major launch will that's a new be a

be with very much we'll So mobocertinib. ready

Operator

to move Mr. of We would question. America like Merrill of Lynch. on the Arai next to Bank

Tatsuyuki Arai

first past like quick have be compared the like is declining second Could than through, declining question. And like we business, the the is business about about believe, That a walk of, with year-on-year. stronger volumes unit my I or would therapy sort which is quarter average. versus higher I weaker? which expected I results, like is year see you guidance. -- question like market business my unit Could question sales is full plasma-derived a the like you

question IG the declining That's question. about second is my business So year-on-year. a

Christophe Weber

Costa, the first And Julie, you take second. one?

Constantine Saroukos

Arai-san, it, questions. Appreciate the for

if you GI is year the on expect growth. X% We're We track. key X at communicated. look our our We're doing as an book data full So acceleration well. still we've the seeing for areas, there in -- targeting we're we business have

XX% we So expect the year. for full

portfolio. expectations mentioned, landscape we're we disease, So track rare with . have our metabolic -- the some that there competitive GI the track. as basis getting the Rare phasing on there. on that's hematology we're on also one HEA, is there. is on Rare the Ramona of

phasing also, drive to Julie the plasma-derived in upside to And saw. about particular, that particularly therapies, can you TAKHZYRO. in for we of then the We talk some quarter expect X, that

-- there prior switch from important year. in IV the up, of or the in past, some so. And first assets you're year of at seeing we're that Because particularly And the the was some opened in switch we've In other in impact pandemic, Elara in time, bumpiness X, the that So decline come because also area. in rebound VELCADE in the seeing the [ph] as last or many in strong X opened the What's Overall, particularly divested had X%. in And oral. opening portfolio, quarter the acceleration U.S., of the year. numbers switched last X is We where in growth of the in back VYVANSE to growth of and again, it's the numerous the to noncore really X%, quarter particular predominantly markets oral now of XXXX of U.S. between seeing here quarter particular always quarter-by-quarter, up. up double-digit variances it growth showing between markets well. between for variation the are customers year. you're neuroscience last and Oncology driven dynamics doing by XXXX.

this see quarter top in that then X. we We of So on quarter well. vaccine. up record acceleration growth. in the an that, to Moderna here will X ramp seeing as And revenue we're of opportunity an continue started to is This just COVID-XX

of what saw growing the So last are the it year, very at XX%. will at in X. We similar global XX believe X.X% growing growth we levels quarter was overall, where brands accelerate, to

good So to runway, start especially see runway, good but we a XX global brands. have positive the quarter, with the we a

Julie Kim

here take it I'll from the question. for IG Christophe, And

thank So you, Arai-san.

it's In the a difficult very you and the look terms at quarter, year. quarter when to of take for extrapolate by IG growth, quarter performance final

FY very 'XX. So previous growth last phasing we to due X, year in had and difficult with year quarter in a comparison the significant

consideration already in IG. of a we roughly roughly X. for growth X% XXXX, into quarter take a In overall had we XX% growth growth ended in we of IG. digits. growth all we this give X% that, the growth for year the minus XX% X, on that year our X% quarter FY FY we if the in 'XX, difficult the comparison growth with ended again, for So XX% confidence with in To IG mid-single to and had We we look 'XX a QX, are to And achieve trailing with the some if at XX% XX-month growth, it's from in are year. the quarter, you but we track

track results. much very again, achieve to year-end the So on

Operator

like would to next Daiwa to Hashiguchi-san move Securities. We from our question. on

Kazuaki Hashiguchi

Securities. X Daiwa I from Hashiguchi questions. have is This

the value Why to was be to volume Breakthrough more just specific? FDA phasing my slides why data number? I occur half the question. in target That Not for is read phasing that of approval. the slides. approval? XXXX the second in occur designation about the POC from would and after you question, achieved. apply did breakthrough given, year, last this And pipeline, to for for TAKHZYRO and is did it BTD, what accelerated be And question comparing for first But come at your is And possible low. That think immunoglobulin? a you for be this first Can data, 'XX, is TAK-XXX. but second for will possibility? year, with as first that therapy this sales available. to quarter on Is looking the the of The the I the POC

Christophe Weber

still Thank of This a the are pandemic. year year because there the you, a with pandemic is was year Hashiguchi-san. phasing I last situation. exceptional mean different the dynamics phasing -- -- year-on-year because within basis, very phasing the

for different So VYVANSE, Take dynamic. have you example.

that. You didn't mention

need you an by to explanation. to So product product get go

Julie granularity on perhaps a immunoglobulin, then and take the situation on give Ramona the can let's TAKHZYRO. bit So more

Julie Kim

Hashiguchi-san. Thank Yes. you, Mr.

there So IG, in U.S. as at growth, I'll again, terms lumpiness where mid-single would tender are call digits I terms in well look sales the the of of you both as trailing which emphasize is, of it, XX-month just because is contracts when sales the in we

growth. extrapolated So it's something on for a that basis not be quarter-by-quarter annual can

Ramona Sequeira

can mentioned, product every And has COVID as circumstance. because unique TAKHZYRO. had a I Yes. a speak a bit of Christophe And to bit little really of

So the really in last down, year, on with of VYVANSE, time, the that. This we quarter, year we're this and on shut the example. the same market as of all for VYVANSE. the And school child with market adult second saw growing grow we're impact year seeing top at instance, the so an

bit For different situation. TAKHZYRO, a of little a

for strong little of from into bit was I a heading bit year, So patients. that of, adherence channel were they a say, had last product as very was available sure buy-in It and pandemic, make little very, there hoarding. would the the to we

a more the more those the of We we're so steady don't with year, and steady pandemic. in buying Now shifts a this we're pandemic. state in, state with in see

And so that that year. we last saw we're seeing not --

example. be this. for that So expected would It's that TAKHZYRO planned the had we would all -- I and say

the to or say on we at in planned the had plans tracking year. tracking, And I of we're as we of expected on how based we're very ahead these forecast COVID or quarters happen much that would last had recovery based kind our forecasted. look year, dynamics different for we and our for So that looking at

Andrew Plump

I can Hashiguchi-san, TAK-XXX. add, on Mr.

about excited very course, the therapy designation. breakthrough of So

on studies the this step public the in later year. -- open will a formal and program the data takes through has from this Phase already we've be breakthrough Just series Pharmaceuticals. There a II, runs quite II Arrowhead allocated the label unblinded Arrowhead pivotal that Phase seen of over where a to Takeda is results. was domain partnership designation patients striking that with based and actually forward. back, more We study is presented program then for Arrowhead

see with much we'll breakthrough we that from the of but that design protocol been filing a inflammation. for difficult therapy of also more have very at well, programs, that other high spaces. now NASH looking could fibrosis. induced alpha-X -- We'll used The also way those the We'll to already results study So with we'll in clear liver disease designation, a similar certainly design down sense very patients that factor a is that's reduction pathological but get as the been robust in Whether through, accelerated the conversation looked think have have could a this be have data agency up of gone we until aggregate disclosed now the very data the liver alpha-X for for of space, PI*Z starting more direct all The challenging we of source sense that liver agency. has study. to And have a antitrypsin liver what get antitrypsin. disease.

gives do -- up need to to changes think case -- in a dialogue. for designation of unpredictable terms lately next but over demonstrating been fibrosis You has FDA the window and then to to show base our I of showing certainly, in a start III terms studies We're timelines. time clinical to accelerated actually sticking year, to commit benefits. the still they're approval. Phase Takeda in having And we're willing have But at us what discuss gearing a breakthrough

be conversation. we'll certainly in So that

Operator

Next. please? Morgan Mr. Muraoka, Stanley,

Shinichiro Muraoka

is is My This Morgan question for Stanley. SG&A. first Muraoka, -- about

Y-o-Y it's think plus I ¥XXX X%, billion.

so? you SG&A forecast issue, to Page this then also could X, that Are think explain Second why Eohilia think think be looking if do seems you is reasons to there, flat. maribavir year-on-year, be at substantial. there increase I was and chart approval, an to I this behind? I is delayed you your any you Eohilia think consider QX. not question of submitted. timeline there is In the But that

in May. it But think to be know reason seems And like maribavir, So expected the quarter. like now was the this it of I'd third delay. I to is the PDUFA

So background could the this delay? of you explain reason also

Christophe Weber

Andy, the Costa, one. And Thank first you, Muraoka-san. the question. second

Constantine Saroukos

Muraoka-san, Thank questions. you much, very for your

that increase to you're SG&A quarter SG&A exchange, foreign XX% of year core highlight the when is looking in X Firstly, fiscal SG&A the XXXX, me the let number. increase and the related versus at reported 'XX

of XX% FX headwinds. is So increase that

middle countries when pandemic, the compare locked beginning it right when and COVID markets down. you many of the Secondly, of were quarter year of in X last the the was of

products, space seeing of in activity markets the that XXXX, much new in in wasn't where there a number significant in launching we're reopening, SG&A. we're So particular China.

strong in new in the topline So revenue we're reflected seeing we're China. in in China the that's of investment seeing the products, -- the launching launching growth on and growth growth already

of So overall, FX. is XX% SG&A increase is that --

from. last growth. line in we're great thirdly, not choose Secondly, real is investments baseline for particular Thank China, question. preparation, launch markets And the a revenue much you our to year quarter in like X top to of help very seeing your drive

Andrew Plump

Andy. And Very Muraoka-san, on it's maribavir. briefly

of kind the you to understand Just make sure situation.

submitted the PDUFA towards accepted is -- May. maribavir November in priority X-month is date and So of for in a we review, end our year, which review earlier We received the it cycle, this November. a dossier which was means

for significant a event like date this the target certain had they missed don't With timeline. submitted because at that we is do So Eohilia, to the PDUFA obligation high what know there's at the FDA had PDUFA approval earlier maribavir the end is looks a tracking PDUFA year. very We quite agreement We which their this a point. of date according last their to percentage FDA hit but date. year a to of -- PDUFA an date, have dossier

with And hopeful on iterate sense you where There sponsors confident And We're feel of line on are X, profile best material. called sense just requests not chart, FDA what but profile, very that information a still one, but of the might see clinical any what every chronology We have our timelines consequences. overall that now. based it we're from on in in dialogue is So the drug. the time miss with it feedback safety right FDA. are that's will the when directionally they don't be approved, occur, profile, still we time this has for the the FDA. Slide on

Operator

next there? the you to question on from Moving Mr. Sakai. Securities, are Crédit Suisse Sakai-san,

Fumiyoshi Sakai

hear me you now? Can

Christophe Weber

hear we Yes, you. can

Fumiyoshi Sakai

I'm on questions. sorry. stuck two got Yes, I mute.

comment your level high question. a just Plump-san, brought me Now

very is recently approval FDA accelerated unpredictable, especially process. on said You

Phase you what the this you you disapproval? referring going you development can -- your mean break specify Alzheimer the be have to are III unpredictability? to you this Or event you of Page the in recent development to looking Now Now Phase X regulatory given Because especially narcolepsy have I half, therapy narcolepsy status. drug, of sorry, be by important here? slide, this already alignment second what may are at Because right, X Type coming, for related program? discussing

many have concept innovative, how -- IIb here, clearly, all make you get is I questions want that's right? but understanding this mechanically the Phase to questions. but is sure know outcome these process, just to my So I that given Now right? I I'm of if have don't proof are

Andrew Plump

Yes.

on clinical me an the that's designation product end we biomarkers approved designation by not predict accelerated have you're a endpoints, First, regulatory on different than approval of will When an clinical we that just say based approval. [indiscernible] that The believes program, let that of accelerated the agency, based means accelerated agency the points. having was say but an regulatory

exactly just with in the So neuroscience mentioned that you disease. happened example what Alzheimer's that's

narcolepsy TAK-XXX for Type accelerated approval. not is X FDA Our and base an case

registration. case is base on accepted Our endpoint approval based for

on but by approval highly not accelerated, So the actually it's an accelerated putting timeline dependent that we're FDA. forward is

accelerated closely will designation, And the end length Now but study, with and opportunity, enable what's that be whether are chance with that of or data are even FDA are this opportunity the us. profound the for do points, is the certainly what a what And to there real therapy that not sit path. this comparators. very the we can will that breakthrough have that we'll an exactly we having required, a with fashion, discuss privileged in so designation still think

Operator

question. Nikkei Akama, newspaper. Mr. Next

Kenya Akama

Nikkei newspaper. This have questions. Akama, I two is

FY in planning status question to this. ending actually submission that XX are regarding will on Japan? achieved? to by what pevonedistat current innovative First, commitment what is to a that September. 'XX Second is submit -- the the the designation. I status vaccine, is FY you your drug believe going of its What Japanese discussion believe it But within MHLW that I the Or had vaccine to million to -- March you supply you And what progress? to Japan. the end said understand delayed within the Moderna goes Andy. Japanese made? regarding has indication be status doses going submission? that And are in to obtain? approval is it is the 'XX, like terms Is actually So get And Christophe. the delivery is been in I'd of

Andrew Plump

question? the with Christophe, would start pevo you to me like

Christophe Weber

Yes, please.

Andrew Plump

Yes.

much the question. Akama-san, very So you thank for

from So you. is me. low-blast have basis. the first certainly global myelodysplastic those pevonedistat a the III that next of study determine Phase global the steps be this high-risk data for get We that step Japan in and will receiving to syndrome for study, and in don't AML. timelines PANTHER the on the pevonedistat We'll year, for I can front registration actually study fiscal

-- will will dialogue could with dialogue will the with studies Japan. in a do bridging then are what MHLW, certainly but to have And like We look package require to fully we registration -- dates. get those further we

Christophe Weber

to working answer Thank Japanese. to vaccines for question, on on will hour, ask providing the I basis is second Iwasaki-san minute, second Akama-san, you, the because daily, he a the

you Masato, that? take So if could

Masato Iwasaki

we process, and U.S. Minister necessary heard. on that announced. we'll supply supply And outside been already I'd some of at minimize manufacturing, partner Kono, in point outside Therefore, with question. that's to you for repeating I an much, Moderna, the during manufacturing very were what Thank question. made, how also has know discussion answer your such found. there your U.S. in already, inspection what was like of been is its able what time and is much of for am to vaccine this from announcement that's be to you the Today, also delayed, under and back Thank we very The track. any delay Moderna's issues together partners, put

importing get soon Moderna, we achieving on a quick our as as focus and our as delivery and side. much. as those will from on -- process ready, possible we us, Thank very for the we within Japan are So you vaccine

Operator

please. Because the to last From next tonight. we'd constraints, for question of the JPMorgan, make Wakao, like Mr. time question

Seiji Wakao

Can will approval it? have the impact is hear or This you Novavax current it Where of one from Novavax government vaccine? me? about vaccine. Wakao is the 'XX? year, be know Is I the in after profit question obtained JPMorgan. will Okay. booked fiscal we it when March the purchases And

Christophe Weber

the date will in our clarity, delivery. in think greater guidance, greater we I in the as of as include we our supply the -- and well as it the information forecast approval Well, launch possible formalization Japan and about as have soon

when to as about it we that we of could bit schedule what are but supply time we working and we possible type be a as need to. So Japan delivery vaccine hard in soon to in very bring very, And introduced committed. the are very information could Novavax Japan, the the precise commit be would more

Christopher O'Reilly

we'd your for despite like us, you. you continue much you, to joining the very Thank very support please and today. Thank busy webinar to call conclude that, Thank With schedule. Takeda.

Christophe Weber

very you much. Thank

Constantine Saroukos

Thank you.

Takeda Pharmaceutical Company Limited (TAK) 31 Jul 212022 Q1 Earnings call transcript