ALXN - Earnings call transcript Q3 2020 | Alexion Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to Alexion Pharmaceuticals Third Quarter 2020 Results Conference Call. [Operator Instructions] Please be advised that today’s conference may be recorded. I’d now like to hand the conference over to your host today, Mr. Chris Stevo, Head of Investor Relations. Please go ahead.

Chris Stevo

operator. you, Thank Good morning. on third for quarter us call discuss joining to today’s of performance for the Alexion’s you Thank XXXX. home. doing This we has call each are recently, from the practicing physical been distancing and our practice are Today’s call will led by our Ludwig Hantson, be CEO. Aradhana by R&D; John Officer. of our Chief Brian Global Operations Goff, our joined Orloff, be Financial Global our will Sarin, Ludwig and Head and Officer; Chief Commercial

and time begin will the questions. We for reserve the rest of a presentation, call the we’ll brief your with

slides will section going on be webcast Investor this the and other by on page access materials call to can You that our website. Relations of presented earnings Events the our

you. GAAP give be Thank measures to our our CEO. in Ludwig? information addition filings with that our to measures, our making to I’d considered results remind discussed using the my cause in law. results. but the duty financial we materially. provide detail. we as today, I and you these financial and which SEC results financial to, the our we Please apply financial ongoing of certain a and of risk statements forward-looking for release. should These differ our our any Before only no useful for at we look take that included for will required press uncertainties we involve factors also point not by forward-looking would statements non-GAAP except understanding business could statements, update will as be performance. believe substitute the of be like that, you of actual statements additional begin, a non-GAAP undertake pleasure that to in like And Reconciliations and it’s are These guidance call, out to risks after

Ludwig Hantson

to good and morning, to community the today. quarter third performance and share COVID-XX Thank systems families pleased I’m worldwide. our test everyone. continues global Chris you, healthcare

and the to in a Alexion’s like the focused disease business this this to strength navigate global rare people conditions. and I challenging successfully hard our of COVID-XX, culture testament diseases their our work to and time resilience with through ability lives continues mission employees of centric has and the to of infrastructure rare Our organization. is environment. transforming our our the of new for patient challenges posed shine the continued devastating would deliver. commitment team Despite Alexion to by thank worldwide

and Third results growth XX% quarter year-over-year. XX% financial strong EPS were with growth revenue non-GAAP

business. full we’re result, financial guidance year momentum to a increasing of As our the reflect the

our progress track and continue are $XXX allocation our share million return to in $XXX on revised strategy to We to to capital well year. shareholders million this capital achieve XXXX to repurchases commitment of

ULTOMIRIS, And Our across the PNH. same our ambition XX% remains With in of commercial atypical have greater now resilient on portfolio. to each execution we of conversion ambition remain we than across our in markets top track achieved the HUS. achieve

million to with Our first integration strong momentum progresses. to drive with $XX was We quarter. this as quarter forward look efforts and sales in approximately within underway continuing integration the the ANDEXXA

portfolio. R&D our continues Finally, in progress

formulation the received U.S. we high quarter, mL, per ULTOMIRIS and the milligrams for for Japan. HUS concentration in During approval in atypical XXX ULTOMIRIS approval the

and including Phase completion one in gMG of of advance ULTOMIRIS programs Phase X Caelum’s nearing CAEL-XXX pipeline, to continue in enrollment X trial initiation amyloidosis. We our our partner the our AL

revenues against is The U.S. two The established we It which lead our for expansion ULTOMIRIS achieve and execute. with continue value CX have creation we and of the the across the market is is of franchise before, continue similar multi-year business. shared launch. which have a a patient CX our expand leader years within now top our volumes. with largest neurology, to now to both business ambition on in to we HUS as to atypical our in for markets of As track outcome in strategy began PNH terms

this upon ULTOMIRIS and build additional to continue XXXX. success development generation with We programs CX a inhibitor third

diversify. Finally,

we FcRN in opportunity our our significant platforms we Factor in value As such and D potential and add earlier have and innovative CAEL-XXX month, as shared this XXXX. assets,

also of acquisition this the Collectively, need ANDEXXA, has beyond. address year brought growth to sustainable growing us drive Our us these driving earlier and Xa expand a to this will critical care opportunities unmet business, markets. components which upon our CX three portfolio in allows presence while new Factor

made thus and growth. have have future on which a drive foundation great We far, journey to progress strong our upon

from reiterate like some to Finally, messages Day turning X. Slide earlier key Investor the of our to I’d month. this

best-in-class years, last of sustainable Driven a operating significant creation we establishing shareholders. have delivering this long-term and value sustainable growth three strong by Over transformed for revenues $X growth and value patients strategy, long-term and and for a XXXX to continues clear a company billion to margin. see the by ahead $XX path we foundation billion

current even our of billion Beyond in within sales pipeline $XX see we than value this, peak greater potential. more

uniquely a biotech disease unique is of capabilities. Alexion As company, rare set within a with the industry tailored positioned

of franchises several have a we well diversified ambition continued individual into potential the development three than for platforms assets, readouts Anchored number novel more XXXX. to portfolio next built promising a years, an growth blockbuster five the seven novel have IND the drive future. filings by with and Over data we of a for and by pivotal number

turn all Aradhana a done to success employees. like our Our over financial commitment work and that, company for by With ongoing discuss down And teams call hard their our continued will the results. we’d dedication. the to comes world our thank to to over as now the I

Aradhana Sarin

an quarter Starting XX. Ludwig. third of XX% revenues year-over-year. Slide of billion, total increase We with reported approximately you, $X.X Thank

representing ANDEXXA non-GAAP driven XX% margins the and $X.XX, in by growth. strong XX%. the Operating was of saw primarily of revenue. year-over-year momentum quarter growth QX our EPS we the continued quarter, with are by trends growth margin first pleased with in top line our neurology driven operating atypical was Non-GAAP businesses We in which franchise, and HUS metabolic PNH, continued over trends

Moving to XX. Slide

to Third Tuning growth ULTOMIRIS third in contribution SOLIRIS were to and and neurology markets. SOLIRIS partially primarily driven medicines in quarter the quarter by ongoing the SOLIRIS up for which during XX% in will third annual XX. million. carry were and third lower were treatment, ULTOMIRIS we to made of the ULTOMIRIS versus billion, compared $XXX in from growth product revenue of CX total patient net Total including HUS. the representing HUS. year per key to indications XX% $X,XXX atypical ULTOMIRIS Year-over-year compared was $X.X was PNH million, approximately future revenues across by for volume growth are to million, annual patients offset Slide each quarter maintenance was an indications our sales HUS in atypical conversions X% increase by Metabolic through that to revenue driven SOLIRIS volume. quarter pursuing. were franchise represents the strategic year-over-year. atypical prior launches ULTOMIRIS of revenues a decision Recall, cost SOLIRIS. for we the lower $XXX XX% as revenues cost

activity. Performance return sales right driven consolidation ANDEXXA’s the side demand of some representing after third and quarter these hospital of Alexion’s of of normalization of was million, Portola On by $XX.X closing in by the sales further acquisition. we the first slide, of highlight quarter stalking benefited the the

the Slide XX. Turning P&L on to

or or was expense growing During XX% X.X quarter of the tax the share GAAP marketable the approximately R&D was million million $X.XX. earnings per effective $XXX SG&A third XXXX. shares ended XX%. million cost of XX% non-GAAP was the during with repurchased a revenues. We of million in approximately of revenues. and third $XXX quarter cash rate and quarter EPS at Non-GAAP year-over-year, quarter expense Non-GAAP $X.XX, third $X.X billion XX% approximately $XX in quarter was non-GAAP The was securities

the well $X.X target shares XXXX, of $XXX up the million was we’ve million, quarter, of $XXX As year-to-date. in cash approximately to $XXX third repurchased to billion our million for of flow with the million bringing Free us inside end $XXX quarter leaving year. in the in of

our year Slide to an Now XX, to moving like to update full guidance. I’d XXXX provide

for month, Investor reflect And our As midpoint. year-over-year $XXX the growth we we’re million $X.X reflects guidance. increasing and is above billion this update XX% prior full which revenues earlier our $X.XX Day at the our shared between billion guidance to at this year,

ANDEXXA. is $XXX strong the the trends million that now product $XX be continuous seen of across million in the expect fourth expectations, quarter for corresponding to reflects updated an terms we revenue, is of our we This indications ANDEXXA be demand above increased ULTOMIRIS conversion half second revised $XXX and in continue headwinds guidance ULTOMIRIS including, billion conversion $X,XXX and $X million million. to SOLIRIS implies, compliance and business In to to business rates outlook, XXXX. have Guidance slightly guidance for to million metabolic strong and price continued our the to revenues $XX for

help are quarter-on-quarter you the In the sales full would our addition following. to understand above, the that note implied guidance, year also I by to

initiation patient queue slowed to pre-pandemic compared bill has new levels. Our

third mix of material revenue reflects approximately we not continue and guidance XXXX. U.S. date, in fair Fourth versus have to seen We less monitor. international yet quarter quarter million a but to market certain impact forecasted $XX tender

in be revenue. best R&D to line portfolio. revenue, is $XX. between Non-GAAP continue operating is XX.X% to is $XX.XX XX.X% $X.XX. to to and to of SG&A to margin operating between continue strength. to in XX.X% and and revenues. be $X.XX of be we by and Non-GAAP Non-GAAP we EPS development class expected be spend Finally, XX.X% driven margins, as EPS of our expense growing deliver expected be GAAP top between XX% is XX% is expected expected invest between to expected Non-GAAP

guidance. quarter, of quarterly On world, we international a across third the the the evolves implied our new view for XXXX Fourth rates to based of revenue impact $XX fair million the queue globally, versus have care as of situation discussed, rates. Slide certain tender medical quarter we to of on around approximately indications, access XX, midpoint revenue patients guidance markets continue starts including previously updated U.S. and of the mix less following fluctuating monitor unemployment and fourth revenues, reflects our As given our COVID-XX compliance XXXX. forecasted quarter of the including

to R&D for be that, I to We will full turn our With call John activities. an growth expected be to over update growth expect to on the year-over-year XX%. fourth is X%, year quarter the provide now while

John Orloff

can Thank you you, Slide pipeline. XX, Aradhana. on see clinical our robust Starting stage

our on Investor ambition thus cardiology ophthalmology. shared tremendous of and our presence entrance programs breadth we we on we potential support have hematology, care, Day blockbuster XX clinical metabolic, neurology, plus into support franchises, XXXX and such The far our development. to today and our in also October, earlier made in seven progress planned in As as acute our existing aim expanding areas, for nephrology, new have

platform with ongoing and even more ALXNXXXX, CX our This third late-stage announced with patients. advance programs disease an emphasis includes We numerous CX pursue planned with newly on indications to we continue generation inhibitor. reaching rare ULTOMIRIS, our to two

forward to dermatomyositis, in recently next We data with Phase reinitiated will expand year. initially from and top be of healthy our XXXX and the study taking share expect X first the to gMG neuromuscular half both line presence diseases in volunteer

We this portfolio Earlier atrophy. therapies. also provided advance our and diversifying continue on CX update expanding our in pipeline geographic to to great into platform, innovative including an make month, Factor strides plans D we our outside ALXNXXXX of

ophthalmology. this established of properties, for already well make believe about the which proof-of-concept we been complement that number are asset inhibition, program, as this excited has given well-suited We as the with

dosing intravitreal forward preference and in approach. We also program a ability second in X the look to over to eyes of treat to Phase this patient terms the have both year. the see systemic We oral an with both half in for huge next initiating potential of injections, simultaneously regimen advantages

XX, by turning Now to Slide XX to for we our ambition XXXX. committed remain launches

that here quarter we and HUS potential presents. in on programs of ULTOMIRIS view the once The atypical within likely year. the weekly You as current to subcutaneous can program opportunity track see next third each remains the with launch PNH that for filing window for

additional The syndrome on process greater have track also Guillain-Barré of it TMA and Japan this ULTOMIRIS later NMOSD year, on track gMG has achieved the ULTOMIRIS our late-stage beyond greater opportunity novel programs. currently with in remains patients XXXX. remain the Both respectively. we ALS am first in to four Mediated portfolio closed to to for first foundation, progress trials screening expanding of has program share neurology additional scope. XX% year program globally. achieved trial SOLIRIS initiate this that Building in ULTOMIRIS’s assets also the we And half to enroll. enrollment. continues the than than to with trial are our on The in pleased CX HSCT-TMA nephrology half XX% and with Complement diversify to enrollment We continues see and our X I initiate next Phase for and and

the AL amyloidosis. initiated have of program CAELXXX forward and portion the given progressing need of to of look unmet pivotal patients with high the Phase the We enrollment of these X

We in X for Phase current programs. also Japan remain program on our year to with a the cardiology ATTR track cardiomyopathy ALXNXXXX initiate in this end out of by rounding AGXX

dosing. the to copper disease continue Wilson onset Phase in the We with ALXNXXXX of next first transformative Phase be year convenient to of and disease. for its in for clearance a properties, standard potential data X plan trial once oral action, XXXX half our Wilson X has of in profound new superiority of care daily rapid

redefine are disease, to a blood approach. goals Investor Day, total decoppering during a the to body shifting shared levels As by treatment focus from potential excited on by Wilson the for copper our we

to more continue forward look to the here future. progress in We and make sharing

Finally, therapy to remains the on ALXNXXXX track year. Phase this by PNH end X begin of program the add-on development

We robust number the expand of and innovative patients our to will our are ambition serve. that R&D significantly pipeline capabilities we confident

continued far XX QX Turning to milestones. in approval in R&D discuss key has and atypical progress reach for in to made upcoming HUS Japan. XXXX expand thus with its now ULTOMIRIS Slide to

in per opinion the formulation. high CHMP approval XXX received and also We ULTOMIRIS for a the concentration in U.S. positive Europe mL mg

soon. and we Before be two the to XXXX, expected with of additional filed programs ALXNXXXX an end four to INDs expect initiate clinical

looking leadership potential value our are be inflection CX, multiple beyond an forward year creating months. for XXXX complement the XX and to Building in next over we on diversifying Alexion. exciting points Finally, will

over a of Wilson in We Brian? including turn expect With to half, study gMG in study now I’ll ULTOMIRIS highlights the the the provide half. in readouts programs, XXXX that, Brian second top from data to the call number and key line quarter. commercial first the disease

Brian Goff

Thank John. you,

and markets third the conversion to all ambition. our this roughly have Germany making patients our Slide over out first ahead three capabilities. initial reached in a established our ULTOMIRIS teams’ XX, excellent to best-in-class have this Turning by new achieved to well than This value XX% rounding SOLIRIS global launch Collectively three standard of countries two-year achieving to less the in of conversion of and revenues, within two-thirds quarter, ULTOMIRIS ULTOMIRIS speaks months ambition. to XX top PNH up patients expertise execution brings our

Our similar within as achieve ULTOMIRIS on journey we remain for continues to years HUS. track two a conversion ambition of atypical XX%

we Japan received As approval for activities. earlier, team HUS and John atypical is quickly launch progressing with mentioned September, regulatory in in local the

to to treatment improve innovate continue We patients attempt holistic to their experience. for

to the average the formulation an to launch patients provide the by prefer concentration the U.S. milliliter with franchise look we who weekly higher of with progress making subcutaneous of potential self-administer. to choice We’re ULTOMIRIS goal And in the time for reducing expanding a milligram approximately XXX the ULTOMIRIS infusion to with patients. XX% annual once forward per alternative

the XX, neurology of Since gMG for team X,XXX gMG resilience on within U.S. the commercial possible. of neurology new patients proposition the quadruple both year on COVID-XX. to XXXX, to ambition SOLIRIS. by U.S. U.S. this value a the SOLIRIS’s third quarter, this the team Slide in by well we’ve of number total Turning earlier posed added as setting our the NMOSD and to patients as despite NMOSD XXX drive patients continued and makes growth challenges strong

of both light teams balanced to pandemic. additions continuing growth indications. new working While pivot ways of focused from are And to levels, the do in see continue we patient slowed pre-COVID to our new have across on

support value virtual stakeholders and both effectiveness the NMOSD with healthcare are the who ecosystem the to our continue efforts communications of with we to patients. strong of SOLIRIS, Specifically, we experienced depth SOLIRIS for of adoption proposition benefits driving across gMG continue with to given on physicians improve focus and

prescribers identify drive potential ambition more breadth. high targeting also artificial We’re intelligence to new with the aided efficiently, prescribing implementing to

OneSource they’re initiate and to rare patient provides Finally, organization U.S. for OneSource diseases, journey. some that support for once support the a patients treatment services takes often helps time trusted in patients. throughout it and identified consistent In our

patients. facilitate have advantage to with of of helps reimbursement, patients HCPs addition neurology navigating availability. many infusion sharing taken and In OneSource And information site our increasingly, infusion at-home

drivers Our ambition remain key is creation we in growth for our neurology value long-term its and one of confident trajectory.

devastating We the profile from safety continue progress insurance. patients NMOSD with an facing efficacy incredible who SOLIRIS pleased to and we’re risk with offers relapse. every and be making each despite new consequences for

long-term We our expanding population ULTOMIRIS, also their trial path we in a the patients, for Phase with a the see X regimen. continue key enrolling treatment gMG potential with to available, to forward serve contributor prior of Once see growth. we ULTOMIRIS addressable as regardless

great with the launch expect anticipate of unique in the come a expand Given the enrollment. for ULTOMIRIS new as target approximately with the opportunity U.S. goal to ultimately potential even We in we to to earlier patient achievable, see half in XX,XXX to made has market. John’s progress patients market gMG team as our We move And products journey. second XXXX. this

Given the believe the patients the possibility gMG regimens. large the disruption and to patient to insurance population facilitate and number of cyclical treatment needs of these unmet expand we U.S. many line have treated face, of overall the earlier remaining new in patients often

while So the quarters, two over in new a seeing confident we’re forward. in patient we’re slowdown path past adds the

over come. continue new set our As evolve capabilities and COVID-XX in to on foundation growing build a the to neurology we of navigate and innovate years

XX, ANDEXXA first underway. we and had well are efforts quarter the Turning this was fully integration to in-house Slide

the in U.S., As performance Ludwig saw the we one-timers. from when from impact you even some ANDEXXA heard and excluding strong from Aradhana,

has to the a started have in as return pre-COVID time year, achieved people more broadly, this and demand levels the to medical milestone reimbursement saw return for GI consistent UK with of access the more related significant by also care securing first Outside U.S., to active lifestyles. reopened For we we bleeds.

We’re continuing Germany. to intracranial expansion as our UK of reimbursement well in pursuit reimbursement hemorrhages, as

few While a in with to in ambitions. stabilization in we’re seen just the our order a line progress pleased ANDEXXA we to and the opportunity maximize in sales months the have with ways go very short our quarter, for still

to hiring commercial previously, execute process optimize we’ve hospitals, a refocus make hospital top allocation As plan existing new in the to system coming inroads discussed To started to on on approach this we’ll to multifaceted months. plan this We’ve approach. over of shift continue and we the we resources and both tier accounts. onboarding and to

the work built way, achieve formulary and status we’ll economic First, place to when educate And having steps protocols. ANDEXXA use its review. ANDEXXA a into systems an also and the This to with physician to intends to we’ll the already access EMR in ANDEXXA, are use drug necessary drug complete seamlessly. inclusion a to standpoint from bleeding facilitate in

we’ll bleed. of the to ensure understand for to Secondly, raise its value. partner to ANDEXXA hospital and Factor with work institutions ANDEXXA, ANDEXXA. proposition are a awareness identify from build advocacy goal to suffering patient appreciate a of major the clinical stakeholders willing clinical is the We’ll with throughout healthy strong and when value use and Xa All that economic champions aware

to Portola both against deployed to centers network pull-through, choose target will education teams is reimbursement in are we we and are is we’ll initiated and as expansion to are accounts make these Finally, enhanced and field our teams continue efforts expanded mix seek in of by many to Plans in key of ANDEXXA and plans geographic on cross need. ensure in progress growth the broad to affiliated ensure ANDEXXA, even label a success. our focus already follow, time created on label. the We’ll HCPs new to And team at both with of fully markets and more developing use clinical drive the working believe demand underway functional new pursue deploying broader to access capabilities. longer-term facing and

full Alexion’s Investor ANDEXXA our to see of value these pieces of we deliver Day, on each heard essential drivers mid-term you the of ANDEXXA. of the potential as As one and are growth key

I’m take quarter pleased have in teams incredibly While forward calls. this the made you And progress future sharing the on fully some will look with updates with time I execute, more first the alone. just to to

like So now with that, to comments. closing for Ludwig it Ludwig? to I’d hand over

Ludwig Hantson

the value momentum the We focused third continue towards Thank our strategy you, trajectory against on remain future build quarter, and our years. last on growth. believe In Brian. of we to the creation in executing few

the to revenue anchored we in path shared, There resources As our our disease. $XX in in have by to focus the where we be by to revenue We with XXXX. and continued of growth on pipeline, broad deliver billion rare platforms vast have have our the our team portfolio, which we and to double-digit see disease potential pipeline and $X diverse we promise leader the clear of novel entire proud the and team we billion us over very in years. believe is assets open three a is in I’m serve. we our readouts call will will several the made With of the now that, And We questions. the has allow value. and believe Operator? several key momentum number that next the we confident long-term anticipate drive progress of will I’m to continued novel over last these Alexion some programs months. which to diseases rare the of or XX-plus for patients grow multiple significantly expertise, pivotal

Operator

with from comes Josh question ISI. Schimmer first Our Evercore

is open. line Your now

Josh Schimmer

Well, congrats, quarter. related questions, COVID I if of great couple may. A

and benefiting may of and quarter third some is that then slowed was that think that some from reason you. second there you X data, we from answer to be XXXX. in the are for the And also And as that demand interim enrollment how quarter? any going that For an globe, question in lockdowns as impact into first of timing there update? the think you adoption the these are study to thinking new relatedly, waves a it Phase status to of looks that pent-up Thank potential quarter are And extending the ULTOMIRIS, and about effect can any provide throughout the trial? QX the about

John Orloff

clinical, program, both involvement Hi, cardiomyopathy It’s the of the for second fell little can complement first have of progress the we on over I on evidence of well as as know, you on there’s pandemic, inflammatory the here. take up bit. UK. question as pneumonia, the France the based as picking John but growing the severe behind side, growing summer, Josh. a surges patients’ experience. slowdown with wave in U.S., that because activity a as Because enrollment It’s the now well and in

an So in we’ve seen enrollment. uptick

enrolled We’re certain plan and now have of in over do number likely to of we in the first XX% an patients part interim a XXXX. analysis after completed have that

Aradhana Sarin

I’ll take Thanks, question. second John. the

some We in that demand, as markets impact are that the COVID. driven we’re quarter fourth forecasted mentioned, necessarily though, and third third come pent-up some from seeing see wouldn’t international by markets particularly tender in obviously we I certain in we did say was quarter. the quarter orders,

of look days countries. you force mentioned. the account guidance of year, example, the we price still only in the selling for patient at U.S. quarter, ULTOMIRIS And additional our the have working the we we If that for headwinds, And in, definitely are the sort taking not slowdown in waves neurology COVID and seen sort many into remotely. remains for also are fourth but the full

So we are into that taking account.

Josh Schimmer

ahead. ask… going go Yes, to was I

Brian Goff

we’re seeing that, the of This could to down, not just slows bolus in jump continued And medical interesting supportive U.S., certainly, don’t that’s actually quarter it think in in I’ll because that’s Yes, And much claims regional this relates as point COVID overall. for happen effectors been variation the is just one there’s patients when that kind down throughout. U.S. the is about into as gMG have surge so Aradhana said, Josh. Brian. that XX% been I third

we’ve SOLIRIS seen just it’s for alone, the utilization. the even patients not impact overall really that So is

converse, third key call However, Germany, was you in U.S. we in relative geographies on kind guess a the it you I for a quarter where had interestingly, in to the experiment, different Europe know, as of state could

very third growth the neurology, NMOSD both had in we well in So as quarter, give specific Germany, numbers, actually as though, pop gMG. didn’t the nice in

what evidence cool fact you look And we things the of higher could the volume that And that queue decline when off, period. so at that that example may then a the be first during shutdowns. as have is, up patients during COVID have can one you

one example in So that’s Germany.

in yet the but We monitoring. that haven’t seen U.S., course be of we’ll

we’re believe the need more as without whole COVID comments, we in And focused or healthy effectiveness, future intensively we’re that, promotional as really on the of as part important capabilities that’s think I for of going that to had with, the virtual. virtual is in-person well I mentioned my equation state. mix

we the help intended and efficiency, practitioner pretty targeting about artificial healthcare are intelligence out guided really Secondly, excited to that’s breadth us with of prescribing.

experienced of NMOSD the three And and team we’ve years the as experience. have proudest that, particularly I’m patient counting is in with OneSource well thing very is team, as of support, gMG course, strong in U.S. highly most with We both in the then neurology, got a now that

that on are going we’re And go forward. the as those lean so we to areas

Ludwig Hantson

the Okay. question. Operator, we will next take

Operator

comes Our Cory with next question from JPMorgan. Kasimov

now Your is open. line

Cory Kasimov

one SOLIRIS quarter, third just front, Pacific. remains is as you, down nine the of the Brian was mix relates Europe what them geographic for on for about commercial to kind growth but U.S. where first Two I of Thanks and follow-up questions. months in Asia talking guess it sales were strong, year-over-year the in

just potential benefit forward? provide wondering just some And molecule. more you kind there be should So clarity second the and about can over can going there inflections question the and taking some we is, lot. on we’re I about on ALXNXXXX your rationale Germany, you talking kind color of about to in that asset. thinking go timing Thanks incremental then And for tailwinds ask the wanted maybe into and seeing next-gen could first-gen XXXX broadly expect was of what into dynamic, for GA we are a the you how versus but if speaking, that

Brian Goff

to I want to the start with and differences. can some then you do geographic moving Aradhana, the parts financially, Yes. speak of

Aradhana Sarin

Yes.

so think sure. I –

we if quarter. talk about third So the

quarter. very see a had can that – we obviously strong You very, third our

was And clearly regions. some of because it different of

some pull-through in some of international the was there As I and quarter world markets. markets rest mentioned, from third

as new third neurology are sort international, a won’t with in more fourth again, growing really so Japan in seeing say patient quarter was strong what going we in continues adds the I of we regions, quarter. though down. business strongly the may mentioned, growth other are would won’t forecast there example, U.S. forward, in our again be competitor quarter. in the We or the from, see and in And forth. we for We fourth effect one-time, million trials have which exception to is happening would though say, slowing repeat $XX strong neurology, Japan, see of that I

So some those moving forecasting. of pieces the we’re are

Brian Goff

I reflect was Corey, our giving U.S., guys back is know again. to Josh And this just I Yes. I you revenues. Germany, of on Japan Brian, that just two-thirds the about is comments – would that would

what So Japan. as really was what to Aradhana best really pre-COVID. mentioned, third quarter. off was have said, up in position in was cooling opened just I regions in are sense to everyone not Germany still monitor, U.S. COVID things with we countries third to the the traditional are of we as had in hot pleased in I And the think fair very period, the keep it in it the simple, way continued particularly actually a as knows, as it’s probably those U.S., Japan it’s say, Though zone interesting much And was most the continue with a impacts. three the is, the the in quarter throughout

that I slowdown. in we’ve to capabilities we say, that’s This monitor so COVID to successful the added again, the without an imagined will And just in is while with keep period for fact is, COVID. in got place mind or the dynamics. be also what making gMG continue XXX admitted most headwind easily terms we have could of that intense patients the we’ve sure

U.S. neurology we Xx grow, So with say have the must same we’ve I certainly the that term. fact in longer with in continued term the are, ambition growth and persistent the definitely remaining the pleased, in we short to

Ludwig Hantson

you want about… talk do to John,

Aradhana Sarin

on we’re major conversion in mention our given regarding ULTOMIRIS price there’s Sorry, ULTOMIRIS way to of and now well. HUS one other as our is conversion I the thing provides headwind achieved XX% the atypical we’ve headwind forgot for terms in that markets

on XXXX want Sorry, John, you to for GA? comment

John Orloff

Yes, sure.

danicopan. the So and XXXX you’re are than right. when The delivered systemically pharmacokinetics Cory, better of pharmacodynamics

However, actually for atrophy. a back eye, retina, is that is in for atrophy in which using high it’s the important where our melanin very concentrated found a experiments model affinity rabbit allows the treating the distribution geographic we to prolonged to XXXX of geographic as our essentially preclinical of and

support predict the in XXXX, and photoreceptors the despite delivered to dosing and with epithelium, as the frequency, the choroid pigment a Qday that model, on nutritional we the with its which systemic that starts could be of inferior dosing to So such can to the retinal it based pharmacokinetics so that disease support low humans. eye provides

in data don’t And should we so as for similar into have Phase next based contrast year. we’ve PNH on right have that’s that we as rabbit monotherapy why pre-clinical we’re that data as XXXX, X. study middle model, taking And and is XXXX the XXXX. In of now, going announced ongoing

that Danicopan be For XXXX, this program starting Phase for X quarter. on the we’ll

Ludwig Hantson

the Operator, question. we’ll take next

Operator

with Leerink. question Geoffrey Our comes next from SVB Porges

now is open. line Your

Geoffrey Porges

intervals any to ULTOMIRIS, of with not patent a the estimate just on than do there think wondering, questions the NMO? couple you lastly, then your and the if I’m treatments of better subcu? in subcu is study John, can intend that And point particularly secondly, of major ULTOMIRIS, confirm any the are you And expand wide. could indications. sorry, about extension patent And and opportunity as of on subcu gMG you X.X comment, in Thanks. subcu penetration that that confidence will you A just is your life,

for program. the questions the Sorry on all

John Orloff

we regard very spring, have that yes, we criteria. Geoff, strict in line the data achieved top So non-inferiority shared with the to

the margin. bounds fact, are In the well above lower

So there’s we issue no And the there, criteria very data. strong to agency. a regulatory with agreed

So there. ground we’re solid on

the and we’re being conducted for PNH, in extrapolation which know, you data, HUS. the is in extrapolate regulatory year. additional combination third with and As next would generating a the agencies, to attempt the drug filing us to the atypical do patients program, of plan to U.S. us the granted device in quarter both data safety position this EU have which from We

support NMO. subcu same gravis and to filing whether set in now in conversations We’re data see myasthenia a the can

Brian Goff

massive and about receive the are because Brian, invasion a – for subcu be disease do will to see expands they’re their kind they of this is for patients there addition to therapy. I’ll That on two it’s that from the question which months, just maybe And your meaningful not as Geoffrey, while of life, once that of We this a whether maybe patients cohort we patients potential think minimal incredibly certainly market. important have add want again, where or home-based managing that of the subcu subcu over another way we to But in ULTOMIRIS more the it’s therapy, rare said, weekly. don’t very optionality sort have. every going is see conversion

Ludwig Hantson

take we’ll the question. Operator, next

Operator

Our Piper line next of the from comes Sandler. Raymond Chris with question

Your line is now open.

Chris Raymond

Just questions. two

talked happening of the that growth of you could ULTOMIRIS I wonder question neurology but indications – both use off-label sort heard patients. talk I say And any mix think just geography. you about in regardless measurable NMO now then SOLIRIS the for U.S. off-label might around about previous of across between the So Brian, from I of you of then in think of COVID-XX, talk you be heard I kind What’s hospitalized Thanks. to you you the of qualitatively heard if that? gMG? neurology I think maybe Could gMG. balanced these around SOLIRIS. XXX some use seeing, clarify I patients and were sort we’ve I adds COVID-XX in know level development sort SOLIRIS of chatter with But

John Orloff

the data. and had CX I’ll with Earlier professor we showed as SOLIRIS Diano suggesting But have is as inhibition, we pandemic that in data. series and program experience UK we But won’t Yes, five first in and in use case There the carefully a in the it’s that was France, have again, benefit. actually also was patients. in COVID-XX. know SOLIRIS compassionate as with it until benefit Italy So, those well are used do of some experiences Chris, we this controlled access by expanded published uncontrolled France John. patients potential question. there’s a in with There take well.

compliment is is XXX strong terminal blocking part have the physicians you’ve we of said, that scientific along There in have as cascade, believe the Our MAC rationale the should anti-inflammatory the where activation by have of interlinked for successful study, first is a enrolling. some And compliment supported the seen mediators been We deposition upstream interim inhibition dual I for There cytokine and many publications not of a been blocking of CX. coagulation success. data. CX as storm recent downstream by be with which that mechanisms clearly COVID-XX other blocked with were of can data XXXX. of the inflammation and

Brian Goff

promotional In more breaks picking And out And the this obviously intensity with quotes of for didn’t second we patients The more see as of can just misinterpreted. because indications that have may what the gMG point treatment. competitive question, that that very tends a as and than on far forgiving and when observable of it for exactly balanced both see make progress claims mentioned, a to And sensitivity have been with about quarter NMOSD XXX of the neurology, we down. So When no continued little we make a case the gMG note part been it’s Chris, there’s for that in disease split U.S. “A I making. is – NMOSD, those up to have that gMG the other be be might overall we in it is, NMOSD.” down there just to is the patients we’ve states. gMG, had trying they’re adding U.S. put tell. was I referred had is of impact how that’s your I’ll to just date. not we’re I and as – combination relapses around And growth XX%. NMOSD. to including do with they different the we patient relapse need the point SOLIRIS, it important associated I’ll for But

Ludwig Hantson

We’ll take the next question.

Operator

comes question the next Nadeau of and from Company. Phil Our from line Cowen

open. now is line Your

Phil Nadeau

questions Two-related for the Congratulations Good on me. quarter. morning.

about Germany, the First, And follow-up have you it some as wave, do on some once then also are COVID go your the Ebola’s In on made. it because on nine is home gMG the think infusions? you patients last And just patients there like simply was subsided months. recent it the just to another your indications COVID increased or go that second, point sounded was the the six more fact Brian, forgiving immediately it’s we they sensitivity about data across over that COVID of getting promotional what question, proportion maybe In a like if most of comments sounded patients you a last don’t answer suggested disease. – there’s and bit. warehousing away, during therapy that just

is reason happen you What the never U.S. subsides, whatever particularly So we there on Thanks. starting ever patients I will COVID square Or of in proportion aren’t once in CX some who comments. trying neurology? to now see guess, will those therapy? patients, two warehouse I’m for think do Ebola’s likely to will be to go

Brian Goff

Yes. Phil. Good morning, Good questions.

That motivated with On we home utilization. that And naturally see one overall you it’s the expect growth part a by growth. possible. that some said, of center burden what sure to we’re part can appropriately infusion, the that that COVID we fusion to would as relatively And of dynamics. that to is first of small doing do make access available and we as hospitals make much patients

as gMG Germany go Secondly, dynamics I not on characterize away gMG. it with neurology, patients the and around would

But on compliment this through kind therapy rephrasing seeing treatment course, without the education, corticosteroids the what of of remotely are of gMG, talking like. where likely a go patients a era therapeutic to intensive that can doctors doesn’t because dose patients do typical is the lot managed a in lot I high of away. and of you’re think

therapy. patients compliment, SOLIRIS patients with that when in being progress So a I educational to really case relaxed, we saw COVID. appropriate Germany you the And of nice saw and then we during the of is doctors what being think managed intensity converted had in, COVID patients those came discussions saw around

we out ULTOMIRIS with SOLIRIS. the the into the expect point put you compliment to a now eventually of And need to will about when just key fact on encouraging with different that tough all, take underlying that I that’s think growth the sit we sign of say as of mentioned. happens. as when on geographies And very But part we from move first that very where get had it’s that takes there that of have So some be of physiology. COVID we as well the unmet strength, right there. secondly, And when that continued a of about that resilience the as overall, timing phases path I different

Ludwig Hantson

We’ll take our next question. Okay.

Operator

from line comes Mohit next question of Our Bansal Citigroup. with the

now is open. line Your

Mohit Bansal

of for Thanks taking Great. my if question. A questions, please. couple may I

is competition a fairly there are more So in possibility subq your considering that other disease relatively subq FcRn sensitive maybe million. compared other bit here. the than against ULTOMIRIS. Since competing space could or ANDEXXA, also And love expand get talk conservative and that? you actually promotion of patients the still it you. is seems little in Could mentioned XQ utilization could on as the well patients well. We’d sales ULTOMIRIS about the $XX one guidance like MG age to Thank as thoughts be MG a relative diseases, subq state you have as to to other is that given future

John Orloff

order ANDEXXA, start is first quarter deal with of the Yes. beginning this in the would you because Good closed just asked. And ANDEXXA, I our remind everyone I’ll full just that July. Mohit. that morning, having the of first

really integrating team. progress the the with Portola we’re So we making are pleased on

who now Portola on team. – And that expertise of people colleagues of critical our acute care lot we’ve experience. came mix now organization from these We’ve have care to the have with got really healthy came thrilled We’re all the already, board. who got a

the times the opportunity I’ve about we’re focused think three-part what is rebalancing So ANDEXXA a is of to of efforts. a way with on story. near-term best And number talked it’s

ensuring as that acceptance critically important advocacy to got place, in bleed formulary you’ve champions, we’re focused good that’s ultimately So that really a the on with product that demand make sure and complex really clinical as in and got about access. is get first institutions we’ve good generation, making on awareness which that’s goes protocols on. to is as the sure second the access. pillar. is But is third strengthened Physical economic two-part continues site time that And story. access, And well the

we’re Geoffrey emphatically, of so the Porges asked which I do question the way, to build believe value that doing I we within a quarter, quarter-to-quarter, for not frankly, time that’s patients. long-term story offering space would the It’s that that the mobilizations excited on this about. quarter. will when to pull we’re And of one, was take a that through. at we extrapolate ANDEXXA. ULTOMIRIS creation similar what by as even mentioned, an we more look or to in So ULTOMIRIS the out second important These next is that subq. over And are have rebalanced portfolio really And repowered, story choices

potential want. patients for a they’ll and that home-based their there’s the grow the patients, that that best that market. once every perhaps we for be of the treatment, that think will do option believe I profile not subcutaneous that’s be the may I months, say which there key think majority to So two also

Brian Goff

administration XXXX. myasthenia finishing auto addition injector. that’s XXXX, shortly, be is for Phase developing I gravis we’ll ideally generation into subcutaneous mentioned gravis pursuing just moment that small which ULTOMIRIS to in And in end, that to it’s third suited a study And that’s CX our a are inhibitor a volume myasthenia we moving ago, with X

to to with into second of we that, first year. half own move rebooted the have FcRn XXXX in part plans the addition program, healthy gravis our going the data in myasthenia generate to into back next of which volunteers been In has

do is have. in addition patients good a we subq that for offering having that they believe those a So already with option to MG,

Ludwig Hantson

take we’ll Operator, Okay. our last question.

Operator

Meacham Geoff of line the America. with from comes question last Our of Bank

now Your line open. is

Geoff Meacham

good a I have and they’re just guys. Brian. two for Good the morning, for and probably on question Thanks congrats quarter.

stickiness the of does the when major that trying multiple PNH a then the market, theoretically of Let’s highlighted. are few countries get for this view haven’t years to to And commercial in competitors XX% just patients switching that dynamic? a sense So ULTOMIRIS, three your in population. say in switched the you’ve inform of that on

some Japan, stable in COVID the patients’ new little like new a persist It patient should more dynamic So implemented today adds straightforward, that with does U.S. strategies help bit Are XXXX. to a new is process. Germany, more adds? you. is Thank there longer but maintaining seem you’ve of

Brian Goff

Good kudos the Yes. morning, the thanks And quarter. on Geoff. for

challenging in the period. very a very progress we’ve We pleased with are made

converted that about on well, the So ULTOMIRIS. not say XX%, if roughly XX%, question the let’s to

more PNH that’s a PNH, about story prescribing. there’s of – long a especially tail For

of have the to patient. tail, than a this achieved are just everything with one conversions doctors. get So long we’ve stage got of doctors PNH may takes the it at lot more Then time that who education the you’ve sync in a

is going of doctor the for of had aware educating benefits SOLIRIS they’ve months. to patient plus every efficacy them. the with which that the they’re So take two opportunity, we continued all then less about that The us some burdensome ULTOMIRIS. months And figured that’s

We that through promotional the future to navigate the And definitely. over of we believe journey, other have our lot mobilizing continued the had there, benefits aware successful virtual pursuing ULTOMIRIS. more will all I necessarily we be be as be will oriented technology-based plenty respect ULTOMIRIS, strategies community effectiveness get indications teams. I that to well-established. of that time we’re wouldn’t training with we’re but all the with extrapolate in By time awareness era, into And that of new of a the patient mentioned, COVID to help the yes, that

engagement. openly, more without just becoming end I’ve that then intelligence that I our to form the as of are one doing oriented receiving much claims-based cited out patients. artificial disease even And customers treat more who on efforts, go is find examples try think of the teams efficient them having high that targeting deploying to and potential to might clinicians we’re be rare our HCP than and many

of examples in many place. putting we’re that one just that’s So

Ludwig Hantson

Brian. Thanks, And thanks all presenters.

the of top hour. the at We’re

been to quarter. do and so. continue really this want work. quarter strong plan after delivering another had I say my again hard to we that we Alexion to their So colleagues to quarter thank all for team has Needless

dialing of your all the you Thanks So and everybody. thanks day. to in rest of enjoy for

Operator

today’s concludes participating. and this gentlemen, Thank Ladies for conference. you

You may disconnect. now

Alexion Pharmaceuticals (ALXN) 29 Oct 202020 Q3 Earnings call transcript