ALXN - Earnings call transcript Q3 2019 | Alexion Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Alexion Pharmaceuticals Third Quarter 2019 Results Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today's conference may be recorded. Instructions]. [Operator

like ahead, conference ma'am. now Altschuller. to hand go Please to would over the Susan I

Susan Altschuller

third and call Thank for Hantson, Paul for the joining and our us XXXX. you good be today Alexion's morning. be Chief our CEO. Ludwig Brian Orloff, Chief performance joined by be our for Commercial Chief John and Goff, Sarin, Strategy led Head our will Thank will will Global Clancy, you our quarter Ludwig Officer; Incoming Business Q&A. Officer Officer. available Financial Today's and of by CFO in Aradhana R&D;

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

These the call, that risk apply of Before involve we look actual take required in filings we of these our statements, statements only at update risks making certain SEC factors law. additional results Please begin, could statements by discussed and forward-looking as to I and the be would undertake cause out after to no a uncertainties forward-looking point will that the as and any materially. our differ duty like statements except today, to we detail. for

of results. addition press we in be should to, financial also information included we Reconciliations for, non-GAAP non-GAAP believe ongoing results in I'd for our are will provide and These a guidance Ludwig? you. our the you to our but our like substitute financial financial remind performance. considered GAAP that business useful using financial be measures, which release. Thank understanding not measures of

Ludwig Hantson

our of in outstanding and continued the the third pleased Susan, execution proud aspects and you, good Thank I’m X.X. quarter very of everyone. all I'm across the Alexion excellent of business. to the share performance morning, progress

to in ULTOMIRIS the aHUS quarter SOLIRIS These at second start EU are NMOSD row including in approval the in for a ULTOMIRIS approvals, EU. for PNH U.S. the in the the most regulatory addition received the in we July. multiple recently and of For

five and regulatory in received start. are have months approvals we off last four the launches Collectively, global to a strong all

made growing further clinical three four to assets, Eidos, Achillion have and Stealth and We new diversifying Phase stage progress expect we including and pipeline deals; development clinical X add also our in business two developments. stage with significant

We make are evolving continuing to progress company. the remarkable

achievements Slide beyond mentioned. quarter those just X key highlights I’ve third

Japan rapid First, upwards trajectory to has conversion team launch U.S. excellence start the to U.S. ULTOMIRIS. conversions driving our continued and saw launch rapid continues demonstrate we in the across are The outpacing Germany and the the globe, in PNH

Second, we entrance continue marking to portfolio. accelerate approval of rare SOLIRIS gMG, neurology. company's Today anniversary is second FDA the into for our neurology the of the

neurology years as adoption continued as in is early Now gMG later, demand NMOSD. driven be robust largest in on our franchise, strong by track just two to well

to and patients we also portfolio X Third, while Disease. continue in XXXX our grow progressing KANUMA metabolics with Wilson study new Phase STRENSIQ of the

further have external both we through efforts. and built Fourth, pipeline internal our

assets, including business as our earlier, track internal we’re multiple XXXX into and stage even stage in by additions late clinic. have we new early highlighted the the moving also to well progressing as underway grown addition In start with pipeline programs XXXX, development registrational our to I on

quarter. delivered revenue again this we on And growth volume ambitions, fifth, have once strong financial with and our

as on durability we're key the long-term look to growth. focused diversification we're near as As core further drive continued to of this, the we of future, In the do highlighted on three portfolio X. well priorities our the franchises, Slide and order to focused on

CX this. demand and inhibition believe we the The ULTOMIRIS first is supports patient see conversion. is We of that the future

seven diseases. have dosing. of to even we expanded PPMS with help program gMG, opportunity HUS, subcu HSCT-TMA, ULTOMIRIS. Second an more is our patients PNH, is to franchise NMOSD, weekly And expansion. particular CX and In the ALS, there also development

XXXX addition, and potential portfolio. to and have XXXX, complement-mediated we treat XXXX the both a our addressed optionality clinic. the diseases into In current not With by moved variety of

third which been this as XX focused focus ongoing for is diversification, have which have Much opportunities. have pipeline. development to and by grown seven we driven our on additional stage we which years, of of is look specifically than less business efforts, area A of in deals continue our included we have two clinical

We are rebuilding up. from our ground pipeline the

clinical only ULTOMIRIS for three SOLIRIS PNH; had for Just aHUS; two years programs NMOSD. late-stage and and development: ago, we in

XX years. to you disease As launches routes poised Slide launches on patient geographies. coming at areas, over a expanded least potential is and pipeline of populations, span of deliver These can see the significantly administration X, our range

to long-term deliver important Our with expanded in XXXX. XXXX and well positions catalysts value many creation sustainability us portfolio and

company and accomplished incredibly does many a not overnight. And a we've time, of meeting, in Transforming proud exceeding much short happen I'm in expectations. how cases

X.X Alexion further We committed deliver company ensure have very to is foundation established the which growing and into and to it positioned on to a evolving well continue to future. remain building the strong

Paul call third that, turn over I now will quarter to financial our With results. discuss to the Paul?

Paul Clancy

business we revenues of Thanks billion, Ludwig. ULTOMIRIS in continued gMG, third increase quarter driven Starting PNH growth by was $X.XXX conversion. the an with year-over-year. This total reported and Slide of core XX, XX%

$X.XX, of top-line share year-over-year. was an margin growth. expansion basis points, growth operating by was XX% non-GAAP Non-GAAP driven a earnings Our per XXX XX%,

growth third of quarter Moving XX, tailwind XX% price net by product partially to sales X%. a were driven Slide of and by volume

include by ULTOMIRIS with contribution which in business. growth third were partially XX, gMG the Turning and impacted conversion. SOLIRIS driven to the revenue by our XX%, volume year-over-year the revenues of Slide million $XXX quarter primarily from Japan, in was growing States strength SOLIRIS both United

due and impact. impacted interval. dosing $XX discount which Japan. contributions every dose quarter ULTOMIRIS now million, quarter the treatment Recall, the revenue starts ULTOMIRIS each to are includes loading in by Europe quarters the extended the from third a dose there's Subsequent in benefit then patient was in X-week maintenance that

we maybe more revenue on some the even for Recall given to fluctuation create maintenance greater a SOLIRIS. anticipate quarter-over-quarter will with dynamic forward going dynamic this expect dose discount the basis pronounced We aHUS, ULTOMIRIS.

XX% total gMG and growth which the CX in volume growth solid business across The ULTOMIRIS, year. atypically and high-single-digit our and aHUS remained PNH and year-over-year volume PNH grew we NMOSD. SOLIRIS the in quarter, this for Underlying expect continue underlying for aHUS, revenue franchise, to includes

Moving and XX, revenue growth million quarter to revenue Slide $XX KANUMA third STRENSIQ representing year-over-year. and third growth volume XX% the growth XX% year-over-year. the revenues $XXX were XX% were volume million representing growth a for XX% revenues in quarter

The the rate was prior was a reform. in rate revenues. and deductions GAAP approximately foreign-derived was of expense of approximately taxes The Non-GAAP Slide Turning effective estimate U.S. the current quarter additional XX% non-GAAP on GAAP related and of million benefited during $XXX non-GAAP XX%. the XX%. on based or to tax to quarter expense SG&A or XX% P&L revenues. $XXX by guidance XX, in was R&D income Department by tax intangible our year provided the Both Treasury non-GAAP QX U.S. change million

for non-GAAP equity million third growing XXXX We repurchased reported $X.XX. with $X.XX of was quarter, third EPS to stabilization and in quarter offset EPS awards. We In quarter marketable in a our the year-over-year, $XXX share GAAP we third of stabilization accordance in all with approximately securities. shares, the ended XX% completed portion cash XXXX. billion share of We've plan and $X.X

stabilization authorization. authorization completed share This future the $X billion approved as remains Strategic is our we've for This new for nearly week, the prior build focus earmarked further Board to has years. for for capital deployment. the primarily a pipeline primary deployment

to guidance. We're Aradhana from I'll guiding XX% I guidance, prior financial growth now total midpoint revenues $X.XXX XX, the to represents increase billion This which for Slide jointly year-over-year and billion, turn the to of developed. our at between $X.XXX updated range. an

the billion. continued launch $X.XXX in NMOSD launch incorporates momentum combination ULTOMIRIS, and the assumes our of revenue SOLIRIS $X.XXX to the This guidance in of of and ULTOMIRIS U.S., Europe For ongoing Japan. PNH is for and U.S., gMG, the our in billion

to guidance headwind. expected $XXX price $XXX expected of is approximate well and of in exchange is impact restructuring million expenses payments. a to will million. be represent be Turning to net $XX as and our foreign hedging as GAAP XX% headwind revenue inclusive operating is We margin XXXX estimate million between related an X% and XX% upfront metabolics, to

be guidance. to expect and be is Non-GAAP clinical to expense stage expected in XX% intend to margin especially pipeline between to prior increase progress to of revenues. is to program XX% late XX% operating R&D unchanged for XXXX. revenue, We of further the XX% and from expected spend Non-GAAP build development

of prior guidance SG&A Non-GAAP for support to year the around slightly the as spend XX% is from world. full increased we numerous to be XXXX, launches expected XX% revenues

the to non-GAAP announced the to $X.XX be first impact midpoint it's on the This share the and of until recently year-over-year. per excludes guidance well and and not deliver GAAP is our be positioned as per growth agreement Achillion rate share share The of to $XX.XX. financial expect XX% we're approximately between expected is Non-GAAP the goals. a close anticipated earnings $X.XX. XXXX require delivered non-GAAP to to $XX.XX of strong be tax earnings expected between to We’ve quarter per We is XX%. approximately earnings effective XXXX. half

call turn over an now I'll R&D John the to to update. provide

John Orloff

Thank you, Paul.

We Stealth which development now portfolio, leads this programs. in to diversification earlier, substantially launches includes Slide the planned two This with mentioned And announced our year. by as the Ludwig is on XXXX, XX have with grown further significant potential has XX Eidos, milestones for Here development past XXXX Achillion. and this least XX in months at and business XXXX. three development deals

for entered purchase agreement, Pharma to antibody anti-eotaxin-X proceedings note inflammatory with will potential acquire a into we that diseases. an development in I Immune asset bankruptcy also pending

to as continue pipeline So bolster stage early well. we our

key Turning ULTOMIRIS. starting to our with Slide XX and programs late-stage

aHUS. HSCT-TMA, PNH We in formulation at ongoing NMOSD, trials and including subcutaneous weekly registrational ALS least five expect gMG, have and to atypical for XXXX

indications We ULTOMIRIS also update our year. to on anticipate expand next in initiating trials expect you further additional strategy to and

potential enrollment due be Moving to improvement XXXX on neuropsychiatric function XXXX. significant in improving X Phase Wilson’s in for early liver potentially remain ALXNXXXX we differentiated from complete in to and treatments affinity has the XX,XXX and copper, current symptoms our to for highly to track higher dosing. trial fold Disease,

X/X regulators, IIIA stages forward light Following registrational will we in amyloidosis chain moving a Phase patients Mayo review CAEL-XXX with II, stratifying Clinic for AL be IIIB. trial by with and

anemia X emerging supply next lead asset hemolytic anti-FcRN and by track to our early Phase in year. remain for initiate warm a sufficient our manufacturer portfolio. year-end XXXX, to plan to autoimmune Turning anti-FcRN We study on

Phase the will also study of gMG subcutaneous volunteers. in in XXXX of healthy second subcutaneous of X data XXXX, following half generation a begin in We

of we In study data ABY-XXX, from with XXXX. developing of the Affibody anticipate anti-FcRN half a first SAD/MAD addition, best-in-class subcutaneous potential the are in we

right, business the in these will coming from our announced little you see the On a development each late-stage slides. recently deals. provide of on I more three the programs detail

and very diversify for Slide expand programs and additional significantly patients, the to XX, to Moving we to across leverage significant disease portfolio We're which of the late-stage these with have many these limited and rare to who this ultra that patients have is And unmet illustrates our only the options. reach capabilities beginning. treatment needs. platforms, able opportunity rare our

diseases, we complement-mediated example populations much D For opportunity oral currently many Factor and those numerous that see we treat. impact with in FcRN, than larger

diseases Slide agreement XX. into to to D customer and oral first Pending acquire two to alternative that with Achillion. approvals, acquisition announced regulatory is and an entered We pipeline. Factor Moving pathway the Factor last acquisition a of to unmet and of close implicated relevant week This XXXX. is needs. critical would we expected in rare closing complement’s satisfaction for control point the conditions D significant the our half stage the clinical in add inhibitors numerous is

For and ophthalmology. nephrology example, the areas in of

complement allows CX. the selective the fight Importantly, inhibition potential to have continue for Therefore, to pathway the advance multiple Classical standard-of-care and complement-mediated XXXX XXXX Lectin infection. beyond of diseases. diversify provide opportunities Factor our to with both And alternative and administration oral D important to inhibitors pathways rare portfolio

approved being mitochondrial is We announced therapy which commercialize disease. There therapy Phase co-develop weakness, an or currently study a X intolerance. option late mitochondrial novel that debilitating no also with Mitochondrial therapies a with and for Stealth in evaluated is to dysfunction, to Biotherapeutics, mitochondrial characterized targets diseases and skeletal people exercise is are by stage in treat PMM, fatigue a PMM, which recently elamipretide Myopathy Primary a first-in-class potential chronic genetic muscle

MMPOWER-X six expected among with results are ongoing results test the MMPOWER-X informed improvement which walk walking Phase X topline in endpoints These study, low in X and primary for strong criteria the study from inclusion results Stealth’s quarter patients ability. from the Phase XXXX. of showed first minute results

macular and the of Syndrome, addition, Optic to We disease, Neuropathy degeneration. partners with the treatment and opportunity to atrophy geographic provides dry work the patients. patients to exercise look potential meaningfully we the to to In mitochondrial-driven to associated with forward the bring Stealth treatment opportunity to our improve treat age-related with has this option believe Leber's at Hereditary Barth elamipretide

XX, to Slide transthyretin Eidos amyloidosis misfolded, can ATTR AGXX to Therapeutics in neuropathy, which leading a Moving is a and with majority and amyloid organs. or of present series TTR and ATTR The transthyretin for in misdiagnoses develop fibroid before diagnosis of in be disease a often our progressive patients eventually and go either of specialists deposition destabilized both, to or Japan. receiving cardiomyopathy agreement fatal with amyloidosis. through

in for XX successfully cardiomyopathy results than at treatment. show greater Phase X ATTR U.S. average in day of currently X and development is EU stabilization AGXX Phase TTR XX% the after

applying our patients. to Alexion will development in AGXX for Japanese where Japan, to be forward to expertise bring look responsible we

support the incredibly pipeline. global to are be starting seen. dedication advancing progress the this for pipeline of and R&D proud and extended significantly of organization we'd already the grown like and to our strategy. exciting has organization portfolio further our effects is R&D their this quarter building I'm that thank It to The to

that, provide commercial to a Brian With call over to Brian? the turn I'll update.

Brian Goff

on conversion. PNH very I'll Slide Thank XX efforts ULTOMIRIS continued in pleased neurology John. we in franchise. with our for with to U.S., great our ULTOMIRIS patient in with on of conversion, the facilitate then move metabolic an progress launch be Starting continue update growth you, and the to to the start the

is this treatment unprecedented ULTOMIRIS. for just week, are XX months facilitated on of with As patients disease rare This of in the progress of launch. conversion of beginning XX%

launch any majority do converted. linear a curve, a with expect continue on we As as now we PNH not to have trajectory patients of

some our developments maintain have we promising help said, momentum. to That

First, starting a J-Code we're removing as barrier permanent second, a on for greater was a reimbursement treaters. Xst, target breadth prescribing. for And that implemented to October of

in accelerated very path a States. by towards least on remain achieving solid the of at we XX% patient So mid-XXXX of our best-in-class goal conversion United

conversion, and European our already we Germany to time ahead This are launch of the the with we launch is than U.S. where the same profile, to more which progress, the XX% team progress base. the by the benefited a in ULTOMIRIS over tremendous point. is starting Moving July, strength months product launched credit and Germany three of at concentrated at local in treater

And for and order June Denmark as EU countries also while in the access additional were point. we launched still tracking reimbursement launch, the the ULTOMIRIS. We've we're National time physician launches providing received European towards Japan, working ahead to improve agreements. Austria, seek awareness and of as U.S. in is price ULTOMIRIS in in in officially engaged Health the days, Finland, waiting other we a September priority. Insurance while listing early In at launched in we actively same conversion approval we to efforts and it's launch We were of to in

atypical pediatric patients. aHUS ULTOMIRIS FDA treat to Turning to have adult for in to now Slide we're pleased XX, approval and

drive the atypical conversion Here patients. towards differences aHUS. a specific in to launch is And the facilitated our PNH to I'll deliver our few aHUS launch. best-in-class highlight leverage strength to continue dynamics in experience rapid patient of to goal subtle a atypical stable we'll

duration choose for there of if example, atypical to compliance be profile TMA patients dosing, said, potential on duration First, and aHUS remain SOLIRIS. that patient therapy events. We some improve nature disease that treatment. there in general a the eight PNH for and be pregnancy, with on the event and between to may the that increased varies depending is of shorter significantly hope etiology persistence silent in every of its given of TMA given stops risk in populations, shorter the That than week a ULTOMIRIS will

patients present diagnosed newly in Second, acute often settings.

be working conversion SOLIRIS they outpatient So we'll the start to or setting. to ULTOMIRIS once facilitate rapid patients of help patients transition on initiated

Finally, ULTOMIRIS of we global the a pricing with launched sustainable objective strategy.

translates that PNH, in already labeled Given This annually. the discount is SOLIRIS payers. to and atypical patients aHUS at with dynamic higher well to both dosing very SOLIRIS than a resonated maintenance roughly this has that dose XX% for

to we you on forward and is progress our here. updating look team highly Our prepared

Moving the to the focusing provide foundation step XX, see view I'd Slide on providing picture how core of for indications. the SOLIRIS of our durability four to back ULTOMIRIS bigger a franchise, CX and we like conversion,

Our portfolio, be before ULTOMIRIS conversion treated to patients biosimilar ambition earliest the is potential and across believe facilitated for will strong vast deliver the off even launches best-in-class already patients the to majority a we're of underway. with the We launch. with start that

Furthermore, we to patients. more for a even plan to formulation weekly available optionality have provide subcutaneous

profile, given the strategy believe year. fewer and ULTOMIRIS, we XX its on proposition infusions move sustainable and to including value clinical strong per market remain globally pricing compelling needed So will

here, see with be Japan, out the Consistent we and similar expect seen U.S. dynamics timeline can Germany shown in which the in appendix. to play

Slide XX update growth. with our continues on which to significant Turning an franchise neurology to deliver

NMOSD. see can in and on more accelerate strongest a left, also was gMG our you early to than We NMOSD SOLIRIS quarter the in great with This with start. the believe ended gMG to-date X,XXX is the have U.S. treated quarter and patients footprint in As helped gMG we launch our the the off to trajectory learnings and NMOSD for

even Furthermore, the payers given a often additional of is the and and patients the single with profound devastating physicians, SOLIRIS relapse. in irreversible unpredictability and efficacy resonates and impact NMOSD of

monotherapy showing through particular, Phase free from In XXX compelling. patients is relapse on that data weeks SOLIRIS the all X remain highly extension

diagnostic STRENSIQ particularly age-adjusting driven or diagnosis, patients. franchise, earlier we're With helping for ranges initiative, of and our adoption working increase third CALIPER XX of volume. growth, million to XX% appropriate metabolics to our pediatric awareness Slide we testing revenue to of quarter lab by support $XXX Turning reported the year-over-year HPP and

Again, quarter year-over-year driven expand $XX HPP treat was LAL-D both by look our We and we reach. revenue to continue or volume. million patients and growth. KANUMA of With identify to third XX% this and additional reported geographic

and team of to commercial rare diseases. on numerous with is inspiring, to and has multiple patients and fronts us hard the Once deliver again, hope the bring work, dedication expertise enabled

Ludwig? the closing comments. turn Ludwig now I'll back call for to

Ludwig Hantson

Thank you, Brian.

is have business diversified to as expanded Alexion Slide performing We Thanks all our and than a better in the as great a made of XX. on quarter, with of to significant efforts core third X.X is pipeline. the employees. tremendous progress that well as start highlighted before, ever an off

on can and Slide As medicines our see our new facilitated diversification on you we driving of expansion and portfolio. of current conversion, into growth durability by focused long-term XX, are diseases further

portfolio current Our spans launches and to will poised deliver hematology, by XXXX additional significantly XX across and of our cardiology, neurology, which metabolics evolve the composition nephrology, business. potential core at is least

not are the pivotal and multiple XX as programs clinic, There In readouts new well entering stopping here. programs, in the several to months. ongoing and from XX next we're many INDs, exciting programs new milestones particular, including as data

add We efforts. to business continue diseases look disciplined additional through portfolio development to to and further our rare research internal

We focus diseases. of our people delivering therapies and life advancing to also maintain commitment our rare with mission on unwavering our changing living to patients

the we to will Operator? questions. open now call that, With up

Operator

[Operator Instructions].

Our first question comes ISI. from Josh Schimmer of Evercore

Your line open. is

Josh Schimmer

myasthenia Maybe U.S. a one quick on launch in the gravis

fairly implications now. the dynamics of here the have by a your sustainable have paradigm, us Thanks. you the Given myasthenia market we the seem might the might help have to diagnosed on doesn't growth plateauing for to gravis SOLIRIS patients to case. expected would started of the It franchise? effect see quickly. even can I come care most And that and understand be Maybe

Brian Goff

Hi, Josh. This is Brian.

compliment. that take a as I'll So

would the we're make effort. the that into well And thanks the I well. at is We And terms of our did expanded pathophysiology are time, that for commercial great the well both We of we heavy balance role mark XXXX think towards as sure for prepare, entry is course, we of So you're what in underlying at we we -- anniversary progress launch. lot. also depth could said progress. it started when education the team seeing at expect as just lift X-year bolus. we've way, I we noted, be gMG in not did neurology. complement as of and a going launch as the Yes, continued NMOSD our the prescribing of knew we And the end around a And to made breadth. to educational that that of along

being addressable for is I'll again, And population I this at that you a to the, the patients leading market. where guess we gMG XX,XXX. X,XXX the the of with XX,XXX we're U.S. population now over X,XXX can to X,XXX the And alone, of the in edge, broader on still say, of say just that population about in gMG, that the be our while that's U.S. end just severe talk could

journey. we believe So will our on expansion continue that effort us continued educational

Aradhana Sarin

gMG just And and of patients were to over NMOSD. end the clarify, at we September, X,XXX across

Brian Goff

Yes.

Aradhana Sarin

And have more since add continued to patients then.

Brian Goff

right. That's

Aradhana Sarin

question? Next

Ludwig Hantson

going the patient sustainable was focusing and than believe We on focusing the to lot of other excellent competition an on on. focusing different that And clinical that know we're doing say I on we're trial but be are the as we is job. Brian are a this might side, technologies population. type team that there's some business refractory the

with we're really really, So progress. the pleased

Operator

next Our Stanley. Harrison Matthew comes with question Morgan from

line Your open. is

Matthew Harrison

a relative any should and to about MG think Launch competitors you what feedback you was uptake, metrics we thereon. on potential other year? how as little from especially about And as to take I the next just you sort bit that could launch. you think see what more provide -- into hoping AML saw of coming

Ludwig Hantson

that that's are have fact relapse They're strong a about, in very irreversible. we is think recoverable. is characterize the MS they starting and this unpredictable. for because again, And And I've as on strong will oftentimes, be significant would seeing communicated often clinicians. And relatively oftentimes focus morning, this the as every NMOSD. it that not in that launch. educational relapses relapses I One lift Matthew. that point to being With reason matters these still early very Good devastating NMOSD, it's noted, make that, clear to we're is sure as in start. the a clinicians before MS. important And I

the the second the the And off-label out So different. of community. that's in beginning very And really of lot complement, which is NMOSD a that’s use is role there's point. Rituxan

So the who a clinicians that what that some clinicians In early NMOSD there are had the treatment they patients pretty have emphatic need. of that first have this seeing already for sense right as is thought is to therapy. approved we're who good. and that for about now we're days there's They're urgency educational And efforts that make intensifying therapy. they or on a moving Rituxan to identify could and transition SOLIRIS candidate immunosuppressive we're sure our make others so that's from like things now

John Orloff

And is to with data. XX% were were is I'll just the up background to John, ISTs, XXX% all showed monotherapy on Well, add That way the our about years. this regard a they no competitive of background and three relapse majority essentially on IST. free patients

Operator

Porges Our of Leerink. next SVB from question Geoffrey comes

Geoffrey Porges

terms remain SOLIRIS over still Quickly MG. being years, perhaps believe parts -- the whether a could sense the But you in lot the Because transition even moving next question transition. ULTOMIRIS a it's is not and by the give I'm SOLIRIS you confusion some obviously sure of all driven whether about Paul, three for occurs? can of of flat Brian as to NMO us or and but two

we about give a So could be that? how of should you us sense thinking

that's indication that’s been a sufficient on a the orphan ‘XX to avoid will already Japan, any examples play out EU, to you a is transition protected is talk about slides an But helpful. has for Do in the exclusivity ‘XX, related a cetera And could you erosion very for what note, for So biosimilar we're market biosimilar alternate drug how indication? drug when your a are then exclusivity going where be have little available? often timeframe? U.S., on et facing by bit

Paul Clancy

Geoff, bit let will give a that on kind of -- of to question I'll crack try the part drug. this orphan little first Brian and a take at then me is perspective Paul, a of the

want I to think it geographic think to with a you perspective. respect on about

and is we that probably U.S. way, Our and to neurology business expected stay Japan. disproportionately

we aHUS think the world think And to and PNH about the is then, around ULTOMIRIS. way I the converting business

seeing I'd United the So, of give SOLIRIS by that's which guide gMG, that because will before, we end largest the this States. as the franchise there in probably of in now, we're of posts be patient strength the the you, said year, neurology hanging

that we're period to which expect biased those of grow. then, a are high-probability we little studying bit continue were time, obviously, think NMOSD, got here, and a that in but we And we've both to So, over we longer trials. ULTOMIRIS gMG

over a of So business to moving period of longer see kind time, ULTOMIRIS. we completely the

Brian Goff

will ULTOMIRIS. the then year ultra-rare case of this generation-two I'll an disease, has exact second is old that Yes, the that that of I'll kind And technology to And ODD. Brian disease the -- is not there of in XX-plus rare that faced delta on Geoff, ODD a time, generation-one this or biosimilar. be We're versus take take aware the a situation of switch on, between the part product second profile we we where SOLIRIS, at analog which

such multiple whole seen that experiences we more story have ULTOMIRIS. ODD think will way the but we where So, will believe a important conversion haven't will that. a I had infusion many in provides patients side be this We level of have do protection, that that is with of

from part life their very So, it is of we clinicians, as from and becomes feedback the everybody patients as encouraging. a that payers get from well from

Even by well. hear point, feel a profile. to reflected starting as the KOLs dynamic And good if the ULTOMIRIS biosimilar, at the of product of, there and switchback about strength some don't were so, that a see we're I very I availability

Ludwig Hantson

of protection indication to wouldn't regulatory the promote be it. with they that ODD able it from able therefore, wouldn't perspective, in to be And get and their labeling

Operator

comes of question next from Chris Jaffray. Our Raymond Piper

open. Your line is

Chris Raymond

strategic little maybe and deals the have done a pipeline question backfill. just you of all And regard of guys sort Thanks. with the sort to

I a Stealth kind of you aren't and portfolio just that deals little indications. of lead know and noticing beginnings these the So with nice have the Achillion guys ophthalmology

you highlight kind about them them. still of But talk and

is So it's area should clearly, here we maybe a neurology that about just these maybe indication it's been very or ophthalmology deals? as thinking expansion, byproduct successful two moving of that is start another Thanks. of a an in but interest

John Orloff

Yes, ultra-rare that focusing transformative clearly sure, we're will. I and our on patients, it's If journey perspective, impact from diseases rare we range. we we a ophthalmology -- on the for can that within make and We're an rare focusing think be of diseases. medicines strategic believe that can on

take at months. say which as to I on in more I area, path wouldn't byproduct, to this maybe look next discussions but this within we're come agreed would disease the a we have So, going strategically

Paul Clancy

Achillion deal, new I indications just expands in ophthalmological we're territory pathway science -- in includes has and various And excited think and that for diseases. Phase into atrophy the And alternative alternative neuropathy. of add then, would for Stealth ophthalmology. with well most X that proof hereditary ongoing opportunity With that us I the studies optic involvement course of as as AMD of in terms geographic about

potentially us soon. squarely I gets think in very the in ophthalmology space

Operator

comes question of from & Company. Nadeau Phil Cowen next Our

is line Your open.

Phil Nadeau

just each that to what indications? patients a expect investigate happen will The Thanks. could then remind forward a Just subcutaneous us the now? And to as the it you indication of transition of do what the future in in look you ULTOMIRIS, the of the of based to future question We or we PNH, stated you launch, volume on ULTOMIRIS consider injection And version benefit? long would how and takes to do conversion subcu subcu, the have generating there, big percent this the aHUS administer? you're on think

Paul Clancy

devices, device regard and it's So, it minutes. deliver the mills, West to see has And using to X with actually body, products. over the tested other program, don't delivered the are which is commercialized and X.X subcu with the I Gen two applied they been user friendly, again, needle we

device and the our should we subcu of next sometime on completion we're is of bullish second have quarter of program in and nearing very now, the enrollment middle in which we're data the year. So,

Ludwig Hantson

the excited will And commercially important optionality. facilitate I'm an already so, fact it’s is the And step. regulatory about subcu which the available process really

Brian. So,

Brian Goff

are, we that that Hi, excited goes we patients we question patients subcutaneous a it's with to clearly, Yes. may that is some the though, how we're about market can is an providing it function go there active or just once beyond distance of as they a and It choice it weekly Phil, it about, with of research good lifestyle, so that that that formulation ULTOMIRIS talked one invasive, be, simply for believe it's do more versus profile it be infusion are? continue and center, could options the a minimally delivery. function be subcutaneous, from may offer that IV they could or with be that the their for an we've

well And conversion we forward one journey. as continue that to, that look we as on so, that's

Ludwig Hantson

but durability, -- critical Phase think Yes, come also you subcu more next able the address the aHUS. share year be we I you be X PNH to to to eventually could when with for another and should component data the

question. next Okay,

Operator

Meacham from comes question Geoff Bank America. of of next Our

line Your is open.

Geoff Meacham

the so I a across all two? between get Ludwig transactions, in or there as remaining far, with ULTOMIRIS XX%, access are for you barriers PNH your dosing aHUS. the bigger just recent differences differences diversification. between conversion for picture place strong, But the are And rates the definitely pieces on you have And then guys would what payer then, the are or Paul, few. geographies? I conversion Brian, are closer to the say understand and

are this sort of to step you room technologies we wanted the of at terms part the just continued specific in deals, of the up or point, in maybe there how R&D characterize Thank product ask later innings you. for at BD? capacity I are platform you

Brian Goff

ULTOMIRIS our mini Brian, little well the it's start originally pleased proud really And question, team as on just Geoff, that lap, moment the than of take XX% part We're goalpost a the has made. really because is progress. do a reminder moving on Yes, of middle I'll maybe XXXX. towards I and earlier the by victory goal -- of just a we're I'll track to then the progress greater we thought than on or of based that greater that's the am

have And that's to which the XX asked know go the we the all long you and ambition our but I we was are is, Is time be will ago already launch converted, as And as patients bold? interesting ambition is an it's majority the months to is, I XX%, the of there achievable? questions that unprecedented. beyond it here in that not noted,

terms is the our we're XX% goal. the of that XX% way way in already means of math by there of And quarters the three simple

these So what and -- range question clinicians two for oftentimes more prescribers, are who or from time on, we a broader that PNH here effort so on is reach. have focus requires of to broader patients your that one the

the The a achieved which of that we into it of is launch in of year, a important J-Code. month, confidence this at permanent comes is availability reimbursement. that's other now months for XX that thing is typical, a very is clinician tailwind came and it beginning than Usually earlier and the

the And be move toward particularly helpful next launch. will forward we we believe of phase the that that as

So be Again, our in Japan, the that but faster even in the we U.S. and than really U.S. we'll which able Germany tracking feel make. actually not progression is to just good about

Paul Clancy

and crack and on -- and to that as Geoff, your financial R&D A kind of as we with call, no of organization thinking think think kind if resource the is a it, going capability. is over XXXX, into I pressure to call this planning that as R&D development. that building address upward perspective, I kind is it to go well kind this from to the and we perspective question relates a doubt of I'll about perspective, want our connection R&D keep alluded Paul. business at capacity people on the plan there we've as additional And so particularly the do welcome that's with is From builds. take additional how good of we feeling hires few allocation welcome pipeline is we work added that a on the last

absolutely it solvable. a has in think think So, is business opportunity is connected rare while organization not of the And with what I then, terms that's Aradhana development I but diseases, built trivial set in there opportunity continuing to pipeline to build press the with well. John, Aradhana strategy of continuing and of on to pipeline to anything as build clinical the externally respect kind of kind to set the strong pretty add?

John Orloff

say certainly to get in the keep both the good a we're and that we've Yes. that pipeline tell I and to really come deals would have pace expertise. of organization year position this growth and grown story high-quality And expand externally. with internally really considerably people in our the to in just a BD

now ongoing it's well. going that's So, and

Aradhana Sarin

of focusing what your that's capabilities other question sort was, good expanding different look of will Yes, stay any again, rare it true been focus, clinical adding the type I fit is to will a think disease have think we therapeutic But at part again to, transactions? And stage of agnostic. our for we area the strategic us staying whether assets. on within I

view technology-agnostic We assets that the sort best will unmet and way. needs. solve clinical for be continue in have been that of to can our Again, looking

Brian Goff

I I they Geoff, HUS, of -- that that of discussion, be Brian, to made again Susan of we've commercial part XX% of with payer one I question about to progress and And me covered missed expect with lot it's atypical a feedback the now very have your a ULTOMIRIS, over compelling already knowledge reminded PNH that's great lives.

and we PNH discount stronger fees. permanent is story economic XX% And HUS. ULTOMIRIS with with defined atypical for the versus the in I even covers the Now have which noted, J-Code maintenance a policy, a as SOLIRIS

Operator

of comes next from Stifel. question Matteis Paul Our

line open. Your is

Paul Matteis

I Brian. I have for think two

was of well what's so on what haven't conversion what's then I implications or read think there now if far? patients PNH And the you're that's the in do from And this the that going Brian, Thanks so in European you about to demographically you patients gone I'd unique anything SOLIRIS? So be secondarily, countries? on dynamics halfway different is -- switched Germany? through in wondering, the And much. other U.S., Why curious so are, any? have that the noticed through who

Brian Goff

Hey, Paul.

still of it I connected launch, process some into, anybody we're patient seeing of dynamics is that the in is, they're phase you the is patients awareness perhaps with or next visits to patients ULTOMIRIS -- widely one or -- first of other the varies the cases, around on our expect of through lower also the pretty we're like. the frequency So the not across some There on there as clinicians we call through the in would part move PNH. as advocacy working

a one-off when just this the clinicians. moved is it a the I we've high of then, to And again, through And that they some waiting notice ultra-rare few and we're visits into clinician. I quotes, higher-volume -- volume, for now say is type the visit, moving clinicians. of with because with it, call discussion sort either would third thing largely to have so And I need or appropriate have the it's

U.S. been one that's noted we've U.S., able advantage Japan have is patients as real launch going the They Germany, of all, two I first amortize from noted, I the really as In that's mainly or the sequential then Germany. of the to U.S. had of well. dynamic. of progress And learnings a

is Additionally, concentrated one in that prescribing key Germany, difference are treaters more than the in the U.S.

discredit think conversion. some their them but that's a with in done, not the to speed it's So, I of has aided to Germany what team

Operator

comes Bansal next of Our question Citi. from Mohit

is line Your open.

Mohit Bansal

for her new with like would and Paul to start for the all Aradhana to congratulating I help. big role also a thanks

be missed. will definitely You

in already be suggests could actually a side, math MG it you to Thank it was the neuro quite number big neuro saw making that NMO? could what to you. And the SOLIRIS on in versus you Can that clarify, Now the you confirm of so please our jump or side, XX% patients U.S., biggest question too? contributing extent already.

Brian Goff

Aradhana Yes, to breakdown On Brian. not by so NMOSD. have of is congratulate to versus we neurology, thrilled We're have given we in the well. way, Mohit, her -- gMG Aradhana the be really this -- new And I'll as position.

anniversary as we've I that dedicated this had the line same on best we're actually the gMG. that What fact, it with quarter two-year really is both date franchise. with our pleased to was so and see is progress think commercially, same -- our fronts. we In have a noted the it's on This we about

part's And continue progress with going excellent as well. we to that educating clinicians. make So really noted, had I

good be the meaningful a to NMOSD, very for of business and forward. becomes So the well U.S. that a becoming made balance gMG that see have that a part breadth going And prescribing not in track we neurology just patient how volume franchise also about depth we're gMG. that's And pleased In and progression. the similar by very but got journey, now we're ambition of progressing, going are we on that's we've stated a biggest linear our with but goal. in to bolus few of very months in, both

Operator

of comes from Salveen next Richter Our Goldman Sachs. question

Your line is open.

Salveen Richter

proposed, on it contrast Just look read through? prior on one with this maybe you Could this with and pipeline. just approach the SOLIRIS work we to your CXG comment When the Achillion in transaction. and

John Orloff

SOLIRIS that use a CXG we're the as complement Yes. anecdotal in multiple role as of reports of complement terminal includes diseases upstream has and where There's renal -- now, well targets. plays evaluating that only complement been that been nephrology area and an certainly,

proof be will clearly, at they've treatment biopsy so, got two of Phase mechanism about are Phase following biomarkers as the various XX consistent the on leads year to days renal be complement ongoing, look showed read proteinuria. and scores optimistic that the results the our X And Achillion's pathway that with as with as we will studies, of promising in program, X well us potential eGFR which evaluating of where studies data effects out that they next patients

Ludwig Hantson

Alexion Pharmaceuticals (ALXN) 23 Oct 192019 Q3 Earnings call transcript