Alexion Pharmaceuticals (ALXN) 25 Apr 192019 Q1 Earnings call transcript

Company Profile

Participants

Susan Altschuller	VP, IR
Ludwig Hantson	CEO & Director
Paul Clancy	EVP & CFO
John Orloff	EVP and Head, Research & Development
Brian Goff	EVP & Chief Commercial Officer
Geoff Meacham	Barclays
Kennen MacKay	RBC Capital Markets
Geoffrey Porges	SVB Leerink
Paul Matteis	Stifel
Chris Raymond	Piper Jaffray
Phil Nadeau	Cowen and Company
Josh Schimmer	Evercore ISI
Matthew Harrison	Morgan Stanley
Robyn Karnauskas	Citi
Steven Seedhouse	Raymond James
Ying Huang	Bank of America Merrill Lynch

Call transcript

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Operator

Good morning. And welcome to the Alexion Pharmaceuticals Incorporated Conference Call to discuss First Quarter 2019 Financial Results. Today's call is being recorded.

For opening remarks and introductions, I would now like to turn the call over to Susan Altschuller, Vice President Investor Relations. Please go ahead, ma'am.

Susan Altschuller

Daniel. you, Thank thank to and XXXX. joining on us Good Alexion's you Performance call discuss quarter for today's morning, for the first Today's by call led our will CEO. Ludwig Hantson, be joined of R&D; Brian Financial be Ludwig our Officer. Chief and Paul our Head Orloff, Goff, Chief will Global Officer; by Commercial John our Clancy,

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

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

Ludwig Hantson

here. We've to and year. joining XXXX great for line objectives I'm Thank made so the with on and everyone strong and us on this progress morning. you, start you our already thank Susan, very pleased the key have the far bottom delivered top

some of to Slide on achievements. these highlight Here I want X,

and standard-of-care opportunity in an First, with have ULTOMIRIS, to HUS. PNH redefine we the

mid-year launch goal or year. in just to in Furthermore, Europe on Japan HUS that for the also Germany are our US meet early we potential of conversion year hope end by planning announce Japan in filed atypical to XXXX for file of launch PNH by this track year. to in US We two. approval this with this Our of and XX% to ULTOMIRIS launch greater is a and week pleased in I'm the and best-in-class

on with strong the gMG. best date. preparedness, in hope for the on PDUFA With to growth XX focused continuous patient our We're and into next of our neurology a accelerating neurology launch in portfolio, are we SOLIRIS on seeing Alexion SOLIRIS indication. is June team we Second, building NMOSD, to expand as dedicated [indiscernible] launch date

conference. Japan. for data priority May, We X also in we filing orphan at the received drug AAN In Phase review present additional will

be we of Given clinical data, this transformative the strength SOLIRIS with believe devastating our could for disease. patients

portfolio Third, STRENSIQ & grow our metabolic with continues KANUMA. to

expanding a and is to enrollment also an executing We on pivotal with disease study. our patients ongoing transformative Fourth, pipeline. opportunity have we're XXXX. track to Wilson bring our in And product

internal with of continue X We Phase in we and the trial assets administered in the X have gMG make with three progress trial ULTOMIRIS support a a we to Phase now portfolio stage. patients and two one dosed our in development preclinical to ULTOMIRIS PNH atypical business first registration and both formulation designed HUS. build Furthermore, and to weekly subQ of deals, continue stage potential clinical our in

pipeline focus operational we financial build have is to capacity and core development business the our Additional a and further.

the Finally, upward business. the have we and strong to delivered trajectory very reflect and guidance performance our updated financial of growth

metabolics Turning franchises, aspire and diversify growing durable building our we strategy to coming we as FcRn deliver over continued our blockbuster hematology and four laid nephrology, in X. out double-digit neurology, we Earlier portfolio. pillars, With year, the to Slide revenue our this growth years.

that, to well these disease as pillars, of first in discuss I with Paul? call goal updated therapies results over delivering and further turn to build as to will plan four Paul more our of we now rare of as quarter a With financial patients. to other transformative still sitting not expand we're guidance. the potentially However, each areas even

Paul Clancy

an revenues an Thanks, gMG, of by delivered of quarter start the Ludwig. $X.XXX core ULTOMIRIS Slide with the in total in reported driven We increase in to quarter XX% Starting year-over-year, excellent billion, growth the growth we business. X, the in conversion year.

was Our spend. representing non-GAAP by operating Non-GAAP in expansion was $X.XX, the per of an line margin of points XX% XX% year-over-year. first in basis earnings R&D leverage top share driven quarter, XXX growth phasing

growth price sales and were headwind our Moving third quarter X% XX%, X, headwind quarter Turkey, XXXX. agreement of SOLIRIS reimbursement first by result of X%. price largely a price to Slide The in was volume offset in changes of partially of driven product by of formalized net by a FX headwind driven the

revenue SOLIRIS On $XXX revenue contribution in Slide see driven from the you'll gMG. million U.S. XX. QX. SOLIRIS XX, ULTOMIRIS. volume conversion XX%, growth with strength was growing in quarter ULTOMIRIS owing year-over-year Slide to the was Japan Turning in the by primarily first to and by to partially impacted of the growth

The was we and both first inclusive the high in the be approval $XX volume to strong expect full into SOLIRIS the Underlying it in HUS PNH since growth the quarter remained for business atypical million. full FDA ULTOMIRIS of and single year. quarter digits and

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

P&L Turning XX. on Slide to the

from represents XX% revenues. $X.XX, primarily associated was certain guidance. XX% to During the quarter reported the first We're at and million the year-over-year. million We election property. to intellectual share We benefits. onetime first Non-GAAP billion, X%, or billion tax approximately now of Wilson negative year-over-year was XX% XX% quarter, share the tax with expense I'll quarter per revenues. $XXX earnings turn of R&D to guiding financial quarter growing rate of $X.XX, $XXX midpoint total The or marketable $X.X XX%. onetime non-GAAP in inclusive prior earnings revenues of the related GAAP SG&A an the This non-GAAP non-GAAP effective of in was tax the billion rate $X.XXX tax benefits, for GAAP was by The Slide expense ended per XXXX was the a range. with guidance. to between approximately growth XX tax increase cash securities. $X.XXX driven

of SOLIRIS For our in was and it the Earlier half SOLIRIS to from the anticipated and is this a in the revenue Russia. NMOSD approval gMG, approved as of in modest well U.S. guidance assumes combination in momentum second launch biosimilar year. that a was ULTOMIRIS, This our continued $X.XXX billion. announced initial month contribution billion as $X.XXX

this factored into our it sales, our in and While was Russia original event and represents a guidance updated small guidance overall anticipated portion of our we included today.

revenues expect For ULTOMIRIS, the benefit in patient from to the steady the from year. first we in conversion loading SOLIRIS PNH to due conversion dose US. for XXXX continue

will to to inclusive the dosing. a from we to to is payments. to support XX% represent to Non-GAAP expense million between operating impact and X% Turning as XX% approximately This STRENSIQ prior sustainability, estimate $XXX spend and for is expenses, Non-GAAP expected XX% based be expected to & price as metabolics, of to includes GAAP SG&A to of FX through million XX% XX% margin XXXX million headwind be revenue R&D to the net STRENSIQ guidance our guidance unchanged is grow profit guidance, of strategic at a increase to midpoint of both restructuring US for pricing expected operating XX% KANUMA. XX% R&D the well headwind. expected guidance. XX% revenues operating is margin in given Non-GAAP be and spend related decision be We to revenues. At upfront is $XX be unchanged of expect hedging a year. expected non-GAAP the weight course impact is $XXX to the XX% this year-over-year. in of of to

expected approximately a We expect tax earnings expected $X.XX, earnings to non-GAAP XXXX the effective John. GAAP per XXXX. similar and first be to well share $X.XX. $X.XX now and to call $X.XX range strong quarter, to is ambitions. on per is a rate I'll and turn of With to be growth is The year-over-year. between XX% non-GAAP between over financial our we're midpoint guidance positioned share deliver this

John Orloff

Paul. Thank you,

in our today. progress four We I highlight building made which We've continue our will to blockbuster out pillars, execute on significant advancing pipeline. of each and

have in right columns, programs seen three the hand currently development in XX our we As pipeline.

and During a four Phase additional phasing over atypical slide the dive ULTOMIRIS stage. we past and and would look so Day next in SOLIRIS reported with stage already. at clinical a months. Last conducted outlined XX seven the PNH XX, development you into portfolio XX announced deals, take NMOSD on have and our business pivotal positive month to if and done data three and months we On have total of ULTOMIRIS a HUS progressed program I Investor and R&D X have we our you haven't preclinical encourage deep the R&D trials

trial see XXXX can X half towards in we disease. to ongoing the back trial X up you in Phase of for into Wilson superiority ULTOMIRIS Phase with XXXX As programs numerous XXXX clinical expect ramp our activity

will We contribute. expect and clinical research early development also business

see to our slide portfolio. innovative to now Moving CX patient our XX, you plans can expand with optionality

both ULTOMIRIS ambition formulation ULTOMIRIS every to back an HUS. in and With of year, the reduced nephrology, every in week which with and minutes. in approval planned plan this higher the have XX to filed will we we for eight of haematology, concentration from infusion benefit standard-of-care week on Focusing only our IV raise have patients atypical file PNH dosing time half

with weekly follow in our early XXXX late subcutaneous, XXXX. utilizing SmartDose potential XXXX We friendly patient once approval in or expect device ULTOMIRIS to West’s

XXXX and opportunity indications. and Our Halozyme our for ALXNXXXX additional with collaboration including programs, subcutaneous additional provide

focused We longevity haematology complement extend and leadership. to our nephrology the both efforts expect complement these of durability and

first SOLIRIS, as allow Building would This to patients spectrum expand the I SOLIRIS the Now and as portfolio to with approach Anti-FcRn also June granted FDA of to subcutaneous approved with disease. the ambition is base ULTOMIRIS, us our be for it note therapy were to the serve of on our patients therapy. gMG for Slide US we we would our on NMOSD review to weekly across gMG neurology well subcutaneous launch of PDUFA first our with turning plan In priority in treatment ULTOMIRIS. program that XX options XX. hope date XXXX.

end. to to X ULTOMIRIS pivotal Phase study by committed design are in and for year finalizing patients our innovating are plans a program We NMOSD with initiate for

CNS, see Given junction the well late based exploratory SOLIRIS initiate scientific in the modelling, PPMS a the we and as an clinical on play neurological ULTOMIRIS in of important in an study of ALS preclinical our appears to treatment of as to role in own for in literature, success trial XXXX. rationale diseases existing complement neuromuscular proof-of-concept

CAEL-XXX a and planned high XX, chemotherapeutic with expand intended add Pending the Phase of demonstrated our effect Slide our serve haematology function to AL rate. which to collaboration diversify XXX with target organ clinical patients saw in mortality footprint rare to the engagement and X/X amyloidosis, standard a to Turning regulators, Biosciences with with care is We study current disease is on a Caelum for from as Vivo. proof-of-concept in begin early early XXXX. feedback investigating potential

in program a from copper our XX has chelators to we fold on Wilson ongoing neuropsychiatric liver is Slide comparing and copper Our improving differentiated results enrolled to to directly XX,XXX extract potentially in higher X ability represents Phase with metabolics standard The and trial in symptoms. believe ALXNXXXX patients. to liver, unique copper We disease existing opportunity be have XXXX care a XX, XXXX expand with function potential business. over an that depicted the affinity of

deal, our with for autoimmune issues we suited warm adjustments is supply, made will two binding subcutaneous ascending Due life hemolytic long ALXNXXXX, products. the bivalent with from the there chronic wide plan. its FcRn single in on to a stemming class development opportunity X mediated some in a of clinical to address be Anti-FcRn our We domain. albumin recent a ABY-XXX potentially multiple initial dose anemia CMC our a focus autoimmune may Phase with XX Affibody IgG to Anti-FcRn. study. best With half XX, we believe slide is diseases Moving with autoimmune have a Recall is to XXX gMG. well and have pillar a diseases in range kilodalton

autoimmune study While anemia move this will anemia have studies in are hemolytic warm to we complete gMG. to not supply the Phase now planning X/X X/X we Phase seamless year, adaptive into hemolytic and warm autoimmune

XXXX. and have We supply initiate by have issues or will the early to end CMC studies sufficient addressed these year clinical XXXX

progress pipeline formulation efforts We R&D will for our our turn the updating over also and initiate forward With call a MAD year of subcutaneous Phase I'm highlights to over portfolio for Brian you I'll discuss study year. commercial their continued to thank advance by the quarter. strategy. that, to SAD, end. and XXXX development to looking X on organizations I'd Brian? like course to business for this the the our

Brian Goff

the Starting XX, John. encouraged made. ULTOMIRIS on in four while with only you, we've slide launch US, PNH Thank we're the initial the months of for very into progress

beginning patients this the XX% leading PNH are on ULTOMIRIS. week were enrolled of of with of PNH XX% in one of and indicator a source, As patients of conversion treatment

bar first critical believe team of and patients. we launch, path facilitating achieving of we're very the are least SOLIRIS PNH solid conversion The goal new sets believe of for of years operational on a we in to launch. and two XX% So a towards best ULTOMIRIS of ULTOMIRIS our our our within the success class patient commercial a at to expertise

therapy the key PNH. of a class on see in on attributes the you delivers best left, for ULTOMIRIS As

So standpoint there lives over a XX% policy and been a barriers now patient to physician have conversion been and has minimal ULTOMIRIS. and payer feedback from of defined have for far positive date commercial for

is We with have ambition mid-year. similar launch a in x-U.S. to first facilitate pre-launch Japan in planning in underway class rapid Europe Germany conversion best a and and potential a

neurology XX, the term. opportunity and represents upon to date. our the our significant growth Turning franchise built long gMG, both is SOLIRIS launch of and of to launch a franchise Slide Alexion best success near This

we goal. second for potentially and of attack. announce live We're In and proud year of gMG, fear another in constant we're this as volume. to with over of Therefore by midyear. of the build remains of of upon to devastating be in the are NMOSD month anticipate unpredictable potential by XXXX prevention Patients fact, our for syndication US currently patient year into launch gMG the therapies our SOLIRIS there U.S NMOSD. US full expansion we approved success with being the treated largest the SOLIRIS treatment end as this are actively SOLIRIS currently prepare There our relapse patients the in effects to no that primary excited

Given our these data to serve we sense the have significant strength of a patients. of need, urgency and the

well the now as PDUFA medical right in launch internal expanding and training our underway. are pre have of believe June infrastructure XX date. teams We and place right We our field ahead we

quarter Moving STRENSIQ to our of metabolic $XXX reported million. franchise revenue we on slide first XX,

in patients KANUMA we revenue coming seek geographies. with growth ended $XX and and in the continued of expect XXXX a STRENSIQ We continues from million of quarter as identify new agreements path reimbursement additional on growth. steady

the further ALXNXXXX the with portfolio. their of to to enthusiasm disease, the and the U.S. we'd X we Wilson dedication addition decades. meaningful metabolics patients suffering the the of the for XXXX With patients will and the now we closing over be We in approved I'll care call have in for team to Wilson rare Ludwig? and approximately to approved standard superiority believe to current XXXX, our and and want potential our provide for to Ludwig for disease share and KANUMA. bringing comments. like which differentiation We through grow significant a therapy strengthen potential to see diseases reiterate the if as point from EU for first could call organization's year. I commitment opportunity synergies thank back with move strong turn hope XX,XXX

Ludwig Hantson

Brian. you, Thank

first year, few we months the not great but stopping here. are in We have made already progress of the

to our well Alexion its is deliver of and phase positioned are We build next the growth. in momentum objectives. X.X XXXX on on

long on to make with strategy on shareholder continue meaningful We and to impact patient lives the a create our value. term execute goal

our we that, for like serve trust With continued mission our us.\ for the would will open and global dedication in employees patients Operator? their to I now to their the to call thank we always, As questions.

Operator

first and We of will Meacham our Our now question question with turn call. answer Geoff Barclays. comes portion to the [Operator from Instructions]

now Your line is open.

Geoff Meacham

one for real just commercial guys. quick the a one Thanks for Morning, a I John. then question. and had

for the gating access, a in that US the you looking pretty some that and seems gMG switch enrolling do of pricing fairly the development impact or straightforward studies then to in perhaps also know, rollout ULTOMIRIS think quickly, for the have of driver how obviously patients And - new on competition for terms you for obviously what's breadth the differ patients, it be an on would going expand NMO?. you. but would ask ULTOMIRIS - of for to broad expect factor it's having I and broadly, want we're a US? to you example? would outside to So been ULTOMIRIS to back are find maybe - aHUS John, Thank big I to forward so the guys to you then to outside Brian, you that and as you as more it finding U.S. you for for tougher

Brian Goff

Geoff. your access It's for and with all ULTOMIRIS I mentioned first Hey, Yeah. the with as Brian. progress. pleased I'll we're start question on

I really XX% right lives and policy with value pace key same commercial is we with progress US also the that's the with on of reviews of [indiscernible] in determined timing have - for noted covered determinations. saw with for that policy gMV. course, a scheduled what that's lot you we're track And payers of of gMG story. a a we now But to in launch these As noted, what over the the factor make general SOLIRIS there's their price the the expected

that the and be there And could a that's same the So for thing also in the part setting most X-US, we're covers in bit which formulary be and pathway locally little the are key at you a dynamics And get you a part. single what working I decisions access more to likewise will have then payer then of institutional accelerate academic made through deeper the then becomes institutional that. value of pricing, the similar think determinations, there level. way way course. a policy that need in discussion

keeping happens year in mind reimbursement really a for story And and the for you and first our what about at in launch. Germany determination free beyond look essentially in Germany then the later we just think to in of pricing would key XXXX point mid I Japan, a second year the John… US, it's the pre-AMNOG, then have year

John Orloff

this Geoff, John. is

the you now intensity Japan. regard with US yet those the have those on of as we also study highest we and in we're and enrolment, advantage filing to probably atypical now The gMV trial And that is worldwide. Europe we've and the the in and the are So completed HUS enrolling the know, verge sites process of competitive of study. knowing filed investigators in we

pretty we're quickly to So enroll be as can. confident possibly we'll as able we that

ALS that's later competitive this high NMO new high players the For the going and indications know regard risk to but intensity, with Lower to PPMS again we year. assets field the in start and territory. totalling reward,

So development on we're execute clinical plan. the confident we can

Geoff Meacham

Okay. Thanks, guys.

Ludwig Hantson

Okay.

Next question?

Operator

you. Thank

Our RBC next from comes Markets. question Kennen Capital with MacKay

Your is now line open.

Kennen MacKay

was trial in biosimilar Mainland, that then, could issue and supportive for the Hi. were issues some rest a you from was the help the biosimilars, some was is whether in-house of And maybe Phase here? of I if us of could separately be intellectual partnerships an question. this bit getting given or as? was manufacturing clinical have an just transfer European wondering little that understand you what wondering CMOs before something is with could the such the FcRn you Thanks started that I for X agent - was understand taking that there Europe, something much started I so wondering the Phase or us help got that and if that the that for with this approval X Russian about Generium the

Ludwig Hantson

ahead. go Please

Brian Goff

runs we we corrected the and impurity clinical volunteer when in We've as source But those and you acquired the clinical that ongoing process supply anemia know supported reinitiate drug identified end Study. Ascending issues program we we've For you program. XXXX will studies as well. a clinical warm allow and investigated. discovered these an And Multiple can and PV Syntimmune had a with healthy the Phase progressing that manufacturing were that those Dose we've new the autoimmune of those for Ib/IIa know, And product by in hemolytic also trials. cause drugs sort of manufacturing substance the year this the we three

to original delay starting a articulated pivotal So But programs preserve and the for will be doing timelines. previously we the we're for gMG. can everything we in as WAIHA there

Paul Clancy

for us surprise the for Russian no moving and forward. Brian surprise So biosimilars, so also no

Ludwig Hantson

start anything. And to you and add if maybe I'll Paul, want

As already limited generally that included. Paul It's had guidance. into this Russia in we commentary, We worked to have his noted CIS. believe our it's

requirements, haven't Europe. we In having conducting specifics there program, boundaries seen terms like exact sites of the don't are know, of But clinical EU for Russia it. in and the different clinical we of outside trials CIS and regulated

And Anything so this to we Paul. Russia isolated believe is else, generally CIAs. that

Paul Clancy

I'd Brian that also Mac [ph] different. hurdles to, what just are have protection in we And just well as to point reinforce you as now, protection. said, ODD the Europe right fundamentally regulatory

Brian Goff

Russia. didn't Yeah, we in have which

So…

Paul Clancy

Exactly.

Brian Goff

was an IP we Our Russia. IP didn't - in have

is I it say would expected. So as

most of dealing highlighted. all to Russia, to think and markets. with of the the I experienced Russian it's think with isolated Brian plus countries have We that be us going us

with anything So happening Generium. see in we don't Europe

Ludwig Hantson

question. Next

Operator

you. Thank

with Leerink. SVB question Geoffrey Porges next from Our comes

Your line now is open.

Geoffrey Porges

my the population Brian, of quickly what or I then the particularly is, what and the you come on the is making could recent modeling for next of you're need and the one sense it a beginning thanks margin treatment taking the under NMOSD way you of One that may. in pressure? us they'll you us think patient to also you question. stable for morning Brian neuro you year to operating be that operating think unmet Could relatively active give prepare Is and Good and it's Paul perhaps getting for a it under your start possible and can in or launch, all diseases us franchises. year as the is next at clinical where for inevitable have go? for of margins population feasible looking give the of quickly? refractory on just muscle And then in relapses the you sense if Paul, more trials investments

Brian Goff

Hi, of what Good we saying on Brian. of opportunity, really the with that nearly patients fact really begin it's first question course, we're saw morning, time and be free, of NMOSD every will data focus Jeffrey. XX NMOSD. I'll pleased key think reflect that the we the and your the which have we on Yeah. strength of on start we XX% by I'll in weeks relapse terms the The aspect at had were who is significant. very to

but we're approved are of the had we of in them to treatment the focus label think kind used actively X and NMOSD just we would for severity the the pivotal to launch relapsing all how subset One that's and is as a X,XXX name present the are we or couple. patients important question between We've as that days the differences It's segment so-called maybe the your no we initial our and anticipate attacks that commonly be therapies you and said to about That available off to because of patient of X will once is do point FDA. there would the both our that relapses So that where There RITUXAN in the therapies that gMC, also there going are patient opportunity. in do the level, in well would clinical these the know, about aspects about starting from align educational have it's in Phase of early that reluctance provider approval some to that be be. the with talked a be NMOSD, It's switch these area US do work will level. program. as of focus, the through - that the expect to relapse. we and significance have that very

action believe near-term is mechanism about complement fundamental on is the the Secondly, still aware ultra then unique to addressing rare. moving that, we this we're potentially what is rare of I which be another will to disease. already of also that SOLIRIS competition gMG. potential horizon, what although And of there is than is for point the third from example the smaller But population us course mentioned

excited we're chance to have to neurology on expand and footprint So focus. the

Paul Clancy

is getting and is going ALS, and part Paul. company really is And pipeline. PPM.S. progressed it's which of that little driven Thanks at growing expanding growing I'm growing level is parcel that gMG we the subQ, into probably pointed of the to and XXXX time. additional NMOSD, absolutely you're a would to as because three strategy and we're to in a we of through it by the out love a question. kind thesis R&D, year, not that R&D, broadening Geoff, I as exactly ULTOMIRIS try this you into drive more bit things indications the to from in obviously point additional at it's studies this for But numbers of think conceptual answer perspective a right, what kind see

last FcRn we a have activity business moving the what Wilson, pipeline really call and including to strategy kind I of business XX Progression ULTOMIRIS newer for big around of the XX both assets Caelum the the earmarked through months, over the assets it's development. into - pipeline dollars So development long-term. for newly additional forward coming the from

So that's - but that don't we that you flip do will you XXXX. know yet, into in know, we that we know, is not what - – over

very a is it with will result budget. hopefully growing, and very, a and it's strategy R&D think I actually growing in the that consistent healthy

revenue It's I combination wouldn't leverage kind double-digit you SG&A side like can growth. SG&A kind think flip expand and of we dollars, of anything things SG&A I or those hopefully more leverage margins. progression just to of see the modestly on know, and continue think I top to on down point that. margins meaningfully And of the coming

of kind mentality helps. long what's - the of a the time it a at We keep for will so that level Hopefully with period right over for that do time, business being. for but growing conceptual the

Operator

you. Thank

Our Matteis Stifel. with Paul comes question next from

now is line Your open.

Paul Matteis

comorbidities I ULTOMIRIS. not A wondering more insurance not And quick taking for could separately the much was the drivers and of adopters remarkably discontinuation? the also the population, characteristics you have quarters. whether stable mix? the looks so questions. stable ULTOMIRIS on Thanks much. underlying Thanks are whether early so Are then they offer of questions or couple that younger, it color and over or any of of the or and couple gMG, of patients being MG new past Great. the on the prescriptions less on like therapy if they're

Brian Goff

Hey, It's Yeah. Brian. Paul.

- ULTOMIRIS, you won't I'll probably go patient start as you're for detailed with for I So color be I'll much mentioned able the as in you - the just to order types. that looking give

in what being you're we've of matched of so - been course, who week doctors availability function the it's motivation shift to two rare two the which seeing from PNH, awareness the with of I different to I few ULTOMIRIS aware benefit from cycles in attributes. and significant. made has have life we've going of themselves living disease. And that patients out has far progress reporting is a That with interesting steady. ultra which ULTOMIRIS. consistently is be every up to One it's months, we've a an been had the in of the mean, think is uptake the

new be exposed patient So you the might lot in have patients. the case it - an of who of time been that actually the PNH in a doctors first cases they've to

as patients then have continued as gated it's institutional patients as on pleased they their the doctors at by that progress payers, noted just of their different with why once of switchers, moving we're the product. I And with making awareness we're and access. with the - that That's through I'd and think you'll therapy pass high access we level. well as commercial PNH is With see progress the the pretty awareness who cohorts

far, beginning it's time. neurologists So in in the we understanding larger make you've in very commentary at to complement dynamic And gMG so of to - course some make both we're uptake, mechanism depth that and prescriber, breadth And remarkably new experiencing the terms the the prescribing, for and of I diseases, continue continue we're of see. of first we case a inroads the that on make progress who In in are we PNH. SOLIRIS looking new in to nicely population gMG prescribing, uptake. agree than rare again with profile of us the SOLIRIS that had consistent that that and your out journey good gMG, as and That's product very with payer prescribing would of what of seen background is predicted. it we just plays strong numbers. case In that has repeat with the of on continued continued a is support stable, also

Susan Altschuller

Okay.

question. Next

Operator

you. Thank

next Raymond Piper Chris comes question from Our Jaffray. with

now is line Your open.

Chris Raymond

Thanks.

Just ULTOMIRIS the PNH on conversion.

point. number, a shows think trend I year two I like lot XX% could your XX, that slide for it, it nice a linear on know, continues chart and earlier just at I'm really that looks you linearly, your quite that conversion eyeballing guess you guidance So be trend if than

the maybe you dark antibody critical So curve? pursuit talk you something long for talk. John, or sort you as down that guided it know, guys on options will maybe there any know, would on I what's I initial color conversion that healthy as data you Is to - know, be indicates that those the that could just by you disclosure. you that Is be of indications deciding competitors you compound, But about and indications have the And disclosing multiple You think year. the can the the keeping between gating a volunteer possible? in great. to matter are the picking in more that of end road see focused of know flattening there of

Ludwig Hantson

Chris. Good questions,

Brian Goff

Hey, it's Chris Yeah. Brian.

We So that more year or to launch. right patient than we we’re, stick the the from to to of made. as mark but what really XX% ambition. we we're I PNH ambition track appropriate any end where about say we be predictions would the going a at I'll believed I year, to noted, conversion to by on the in And ULTOMIRIS, with out of we're have bold, that. make X we've facilitated be with progress pleased with same start. are put On the other hedge

that's diseases in seeing difficult I've a that's a the it the to early a and know enough see goes bit far. we what been what what the had say And what little rare has little types not what consistent to asked that I makes bolus, we will essentially long in it be. and four so in executed back stage of patients adoption. forward. challenging to at exact Just the uptake progress seeing Too only U.S. we're are team But questions a a going as of previous expect would in really we're and that about, the less we're into months launch know way to reminder, this than Paul the proud

Paul Clancy

anything define the what would with launch is think pleased far. first we're I of that, But the really our add so months I linear don't the seen and we've six success business forever. in

job, done a That it we're of Affibody? then the this molecule conversion stick has means and back and the value ambition. XX% to great patients what to but it to So – comes a going team for

John Orloff

It's a menu I Yeah. XXXX ABY-XXX, longer that we're for rare of as in well include a considering the autoimmune half volume as With regard we're differentiating terms targeting administration. smaller to same diseases. think of life, for indications subcutaneous features would

migs also over dosing five had looking a IGT hemolytic the the XX and which had cohort. you as we IGT we're scores some in therapeutic target XX% with that I up weekly XX% clinical XX in patients. for what pause. that Phase IV X program, in had from we at to And while lowering know, three to per per in times pemphigus healthy sub year very we IGT seen a response profile. I XXXX, to the reduction prematurely get IV vulgariswe strong milligrams and kilogram diseases we’re PDAI dose XX Again at first we population. And consider therapeutic supporting in lowering have is as data product MAD after study would the a study, to consider we've at what weeks at had reduction milligrams we've reported XX%percent kig, And would pause anemia weeks, then a attribute we a before weeks per over So five volunteer key add reduction to with autoimmune also pause warm sub patient where in kilogram, last we lowering had dose with able

program. very and pivotal adaptive forward take to want get and gMG early We X/X anemia year. positive this into seamless on hemolytic we're Phase studies next So for

Chris Raymond

Thanks.

Ludwig Hantson

next the We’ll question. take

Operator

Thank you.

question next Rama comes Our with from JPMorgan. Anupam

now Your open. line is

Unidentified Analyst

This are calling Maybe and and Tessa with Hi. you on could and this hearing questions one what the PNH thinking taking you ULTOMIRIS, if here. us, how for about our in SOLIRIS the marketplace changes two is for in from Anupam Thank SOLIRIS point? this you specifically a then morning. are I hemoglobin competitively And end update for gMG. second on

on thousand outside US just Solaris those how what one a so in look with therapy been And there getting of percent and currently in patients Have SOLIRIS time guys. source? patients the highlighted of enrolled Thanks patients in sources US? efficiency on the are these in much, mid-April. might of trends curious You

Ludwig Hantson

John?

John Orloff

in So, a and we've of patients had which XXX in and XX% XXX to quarters the and previously XXX stabilization the the XX% trial reported of transfusion in study results three XX% XXX trial. hemoglobin independence

positive impact the study. on we hemoglobin go have in So really up which did XXX a

looked competition you be a our think I low of starting with that's referencing patients may hemoglobin. the out at some

a patients of the the bar. the population PNH which and SOLIRIS have population addressed that previously to doesn't are and of with hemolysis, we've broad patients marrow of to the past no represent anemia representing with potential with hemolysis, and We had with I that issue patients by selected patients and as of said begin demonstrate address. than those as high now as to count response intravascular extravascular is it think that bone less have had is ULTOMIRIS But well a PNH that driven that is which XX% increases overall with which reticulocyte subset carefully raising failure, a

Brian Goff

asked I'll expertise, - be have pick moving April gMG patients a quite the proud of to question with than space I'll midpoint so just gMG down I'll your continued crossed a think to bit little one - up as here question, expect of progress. well. the significant I the efficiency, thousand all, very But me of alliteration I that comes let on I particularly a NMOSD you missed get into approval more if about we're we tried number on in And now we one. have the know it them We try expertise. there with then and it says the in once to starting - fingers

that other but of ahead as for other in that out journey, we from SOLIRIS population I a gMG the and to question. and a not we broad part with potentially because is, we your comments was build like that The noted continue to expertise as we'd even neurologists, in the and So which third noted and we that NMOSD and as I the into. then benefit longer play. prescriber see comes US, we've base I into experience own growing itself, experience, just want had And expanded that that depth. our Outside well my could of breadth on move neurology term, as areas look to did

Japan. Germany both and in gMG have We

in about on progress, from good has types I dynamics. of just been form by similar different prescribing and is different other. making US gated going, to talked fact, to an tends the be are think more we've which each longer probably dependency which slower take of inherently markets those both update. and from calls more Japan on Germany to prior US guidelines,

patients navigate the get on the our are. in of for asked that's we're source, one bulk to majority helpful program, therapy, one US, the which And is in about are we is, one through particularly which So enrolled overwhelming source proud. to in the well system. that last one where as the those But is gMG you patients again as of business had

John Orloff

and with said pleased we're have we SOLIRIS MG never big US biggest business Japan. is the As Europe, really in be but to countries going a two

Ludwig Hantson

question please. Next

Operator

Thank you.

question from with Cowen Phil next comes Our Nadeau and Company.

Your now open. line is

Phil Nadeau

my Morning. taking question. for Thanks

on up question Just from a follow one. last the competition

still in and they - players to enrolling for XXX you have are those biosimilars the competition the or hemoglobin in the the is of Chugai, on move patients and where levels status the branded Regeneron, like understanding so were disclosed secondly, other they XXX have what of what the ever their that's aHUS planning PNH there, changed? trials? First are your plans And then out patients, and studies, forward

Brian Goff

a on patients we to below been other hemoglobin a about X.X during marrow have anemia which and stabilized a in represents study maybe of a had normal. that and in is transfusion gram point value XXX to I’ll XXX therapy XX that X the with XX field, some Contrast is grams the XXX, the failure. XX% was our been regard baseline patients studies, the The anemia. in hemoglobin I response So of monotherapy of in symptoms based patient that where increase as though per to of trial, X trigger trials careful XX conducted or about KOLs Normally based XXX related deciliter of limit you have the had for even hemoglobin low PADDOCK don't like naïve PNH of bone and think the feedback selection lower with know, population, baseline and many as eight, of or have absence the on to a in that from typically study. was there about out are

we broad largest PNH patients treat ever in enrolling today. program. conducted population This patients the So are was you the our XXX with set we nearly that program represents know, PNH of the that

John Orloff

of the Amgen not the Phase are any X Phase in study. for we of X the enrollment status the to respect for active program aware competition With biosimilars

least is but Amgen, month three think estimate this for so that a best study, on. will our at timelines and it's regulatory XX years We take that's So from start. question the an

would know So our [ph] the what for X three not least program. then now any think and it Regeneron, HUS, issue active the means Chugai I a Regeneron, but of phase think because that’s we Apitope I away PNH Chugai on of question years we're for knowledge. I And to it's and aware all at say best and

Operator

Thank you.

from ISI. Evercore with comes Schimmer next Josh question Our

Your line open. is now

Josh Schimmer

the Hey, thanks for taking questions.

the key First, to Japan get the as through for those clearly US, gMG the population. there's can to work Germany it you gating you. of therapy on longer of considering then steps and pent indications little up the incremental more much thoughts a provide markets? of them granularity the Any and how them timing on the beyond severity to Thank gMG for what disease? that patients are And for a will and take unmet bit need the MO launch

Ludwig Hantson

John, do? you to wan do

John Orloff

say Europe US just Japan would and NMO, XX June and a the currently under in in in PDUFA in are have I of for do for then… half we Yeah. the and Those latter review we anticipate date approvals both XXXX. filings

Ludwig Hantson

be a strong And Japan NMO it is could Brian? - a markets,

Brian Goff

Yeah. I'll actually just countries say that Japan than world. prevalence other has the in higher most

us an so an interesting And the case to launch in of US for with in the opportunity the as it's NMOSD match opportunity. up

for? So I was were I those make of to what this approval. around had be you launch half the just opportunities question year, looking gMG. other in which you are would want the then the think understood sure near-term second with And And I

Josh Schimmer

how the markets take Germany So and much need longer pent work it'll was this Japan question to you of beyond then patients? think first gMG, do through for up US, unmet and

Brian Goff

in for US, big so We've the patients. aligns XX patients. Well, population population to of a gMG the many talked But opportunity. the times overall that with it - trial the REGAIN the X,XXX mean, Okay. X XX,XXX about I is is to

patients just how physicians not I hearing physicians personally are in a had of with that we've it's that the pleased dynamic crossed from XXXX So a what's patients action SOLIRIS. experience the just the we is and think this are their if to around number, round because launch, And novel We're before. identify it now how are seeing product point you progress continuing I with at have patients continued very educate line experiencing signifies what compliment know. but mechanism they've finish of and appropriately we with themselves also continued don't in not opportunity? that The a to fact over their where out the plays had. others mid-April, the as peers

think back on go and that, and the growth And – of trajectory so patients that help continued not that I’ll comment stay does a I the to to and centrally solid neurological just market we'll experience hopefully I only and penetration with a build condition one from well. to continues as also neurology it into creates peripheral approval pathway a that gMG, with us in move to acts for NMOSD

Ludwig Hantson

three take we'll more questions. Operator,

Operator

you. Thank

comes with question from next Our Morgan Harrison Stanley. Matthew

open. now is line Your

Matthew Harrison

to of Thanks for end And and is Good that described any study to for is up just a you've second we earlier all question. Will the –on a [ph] we you the as talk push on you then had can that the morning. question. then I - that if the just stop. And that we're you hear seeing what and clarification that John going FcRn data or I'm there's on taking John that maybe back a on maybe Phase something of about and data? that? second, pricing – just comment if been see know, then wonder before guys view the more X HHS wondering will a you as forward. current have Thanks. coming API environment

John Orloff

of dose program to we a anything be to ranging had dose we take the into component dosing last the that would So we sharing have of that in data, of so the study, only pivotal exploring properly a IgG the look clinical trial. beyond XXXX, that shared year terms hemolytic with in anemia and end we would include front and that in some we of had we the fact after Phase forward stage year. higher a to response the those know, prematurely patients doses what this identify a pivotal will lowering further it pause regard as that right not can to because was program And just you cohort, X I said first the PV now

Paul Clancy

pricing With strategy. sustainable on essential rare global focus in in several discussed to pricing we so believe we've this continue respect innovation to a diseases. ultra Matthew, and It we is that occasions

XXXX patients. that solutions diseases As know, we way long, have find those the for a and to long go trying rare you to

that know by volume, driven is also our innovation You growth being central.

discount strategy that XX% point. for HUS conversion PNH is where US we're once discount our then HUS, what and get at You we’ll in start for ULTOMIRIS know, we about talking pricing we XX% have a approval and

dialogue tight proactively focusing so. implementing the the ways of band support a We a we've reference, and is with do that, payers is on to also to single past. There international pricing that in means done continue dialogue And globally going payer ambition are pricing addition we also dialogue are payer, in single that, also that a we to dialogue, potential innovative on Having in assessing the working and dialogue, access. to system beyond potential are which US. a patient said

We have successfully operated with in single countries payer system.

one focus believe and And important topic so we the hope had a situation. believe pricing an on we I that sustainable helps. we've that that are is the that in we this organization right as

Ludwig Hantson

We'll take looking you. more at questions. two Susan, I'm

questions. have for more time two We

Operator

Thank you.

Our Karnauskas Robyn Citi. next comes question with from

Your line now is open.

Robyn Karnauskas

Hi, guys. question. Thanks for taking my

of acting any IgG? lowering in do that or simple on a concerned? IgG, being much lowering profile FcRn be, too do as without other has an impact difference given as is be there in Thanks. it not just it's how so question things second [ph] you [indiscernible] IgG risk would - lowering you So the body if IV, the think far headache, questions can albumin besides just administration And the you do any there lowering do as does complement trial on and [indiscernible] like know does,

John Orloff

Yeah.

it in ABY-XXX. albumin reduction albumin albumin is does that know on regard the we binding do FcRn, any share with not there know for with no epitope we the with to overlap therefore that site binding for So ABY-XXX, molecule so on and

XXXX anti-FcRn sites well, binding the As as contrast the IgG we said also yeah, where of there FcRn. with have competition in binding for albumin some sites to on the is overlap

have some and we IgG activation that So per lowering to cannot regard there fact effects initiated of activation studies The IgG-lowering, already MAD that that that to lower complement with are on want less we is role. fact complement. I lower there that SAD, And of and but in then plays effect be to where say it still diseases underlying that ongoing. don't on is there downstream say it beyond can don't will course, a no to reduction zero, based of the will albumin. we evidence additional effect the we've complement, zero have a

We these and across also know interact the class. and potentially Fc that anti or could do other of inflammatory them with pro differentiating gamma be receptors molecules that are inflammatory some receptors

Ludwig Hantson

two more. I think take Suzanne we can

Operator

you. Thank

from Steven comes with Our Raymond next James. question Seedhouse

open. now is line Your

Steven Seedhouse

might and utilize I decision looks on PNH physician conversion? of policy closer test to either it or since might formulation XX% stay switch guess ALS Thank And have secondly, ULTOMIRIS the morning. about and the that you Could if it's to indications development place proof-of-concept patients IV the optimal SOLIRIS those and And be on the start I with and percent will subQ? total think to or number with hit approval, sort as coverage like exposure? what Thank you. formulations to know, And IV Good be SOLIRIS SOLIRIS? made like you or quantify visited that's just IV higher. to actually and ULTOMIRIS the for indications new because opposed is best of or perhaps explicit to decision the ULTOMIRIS PPMS, case, is their new ULTOMIRIS, far it you. switched drives so on a trying then the to what trials am after to understand as conversion ceiling closer much you what in you XX%

Brian Goff

Steven, it's Bryan. Good morning.

an I that visit on based about clinician. they these we're I the own dictated with That's their a could wish and population actually with lot patients their question, rare talking have but answer condition with which the variability ultra clinicians. So of in their your cadence agreement

who you are a frequently, on some depending physician. less so six see some their who it's agree clinicians, again, with to every their quarter, intensity So some or months and tends they on once have variable, what be

as where facts exactly we to give So I can't the are. you

we're and for just when more encouraged as make payers are is removes one I making think with so logistical progress of sort the barrier they visit. do I that noted that that we

patients detail has who there of awareness experience has among with had then been say, who continues not who patients. ULTOMIRIS grow, physician there's this is the also of can't switching SOLIRIS new days treatment too education this the but deploy it with where have appropriate stage. give a to we they than and may as there's cilia those SOLIRIS not are to more I you just at a actually a And that our first do may any around teams PNH, diagnosed see give particularly that's ULTOMIRIS Secondly, dynamic prescribe component. much then scenario PNH and now part per or also active what switches But option and still and is a early

John Orloff

And subQ atypical on pending the HUS. you get will regard well formulation successful as device an indications, are studying the body of with as know study new in that PNH, in PNH we to hopefully, us as completion with delivery approval

well not go also as MG but with more decision the related plan ALS, to to I through to which to apply PPM think and is subQ timing rapidity, bridge IV NMO. to forward the would the and and as XXX only to

Susan Altschuller

question. Final

Operator

Thank you.

with America Merrill of Huang comes question from Bank Lynch. Our final Ying

now Your open. line is

Ying Huang

the first update. guidance you one taking today my with for regarding the Thanks morning. questions. good is My Hi, provided

quarter's of life if gets guidance I SOLIRIS when also contemplate injection And volume the tender? from just announced XXXX, the data dosing to the If that wondering lot don't can secondly, I you John, then I of to in on you say the of Phase it us let's can room factors might Thanks. learn when $X you I remind guidance. PK/PD and if next the revenue ULTOMIRIS, this see compared a three on today was about wondering So [ph] you add have million. about besides you subQ? midpoint for X the the growth Alexion data flat for both to the for X. and $XXX.X one-time really your quarters, Phase for I elaborate up completed we the was million the maybe

Paul Clancy

pointed on a the that plus be out top stuff you then minus the of a it's we there's bit a our - distributor of strong beginning past, year a Brazil, a then that we're just know, be will kind of That's neutral, to will clearly, one think that from Turkey. plays. how making international basis in little FX profit think HUS, start other We And a in the lot will some out, we change, wraparound impact to. the in on or you contribution That's markets on side, move and year now competitor headwind. as at know a point had I'll of kind direct to the on high beginning digit, of what of the was in growth, the trial just of be as you as on as I'd back end included but headwind that NMOSD Paul. PBT the year point single I year. bit and to have be we well a we through as continues said today, the of we a I growth the pointed SOLIRIS, on a see unit about attributable bit price of the we'll is headwind third MG of it the And little think included PNH towards line. and or the guidance in underlying estimates

John Orloff

dosing device in addition bio studies the that with with able about availability increase which to and is regard bio to that PHXX depends subQ, a XXXX XX% XXXX we're at XXXX, course, we at minimum. of least a require and to the system of it from study now we've able less the opportunity devices. or to us dose increase can volunteers to that the we've formulation done the on the with weeks to were additional results on which that healthy two of delivery availability we And and and dose and frequently This body – may single an it indicate the allows volume be previous XX% every on completed with exploring

Brian Goff

for help device, it that stage that and IIR drug And was the small show the maybe one you we platform didn't of using was day, on those devices dose In you that me… the X.X device was during the – remember volume was delivery the ml. John device

John Orloff

the… With

Ludwig Hantson

it. and the It happen answers I though, hope no that be in to product question.

call. stop we're going So the to

Ludwig Hantson

So that, needless start of pleased say with really the to I'm year. the

As you continue continues and to our great a very to great we well with to off pipeline. and start, heard ULTOMIRIS MG progress is do see

We is I'm team. very, proud the you continue strong our can to objective very do to have election so. of momentum I a and tell

wish I So thank they've all you our for I want to day. a done colleagues and of what good

day rest So Thanks of everybody. enjoy your the much. so

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