Alexion Pharmaceuticals (ALXN) 26 Jul 182018 Q2 Earnings call transcript

Good morning, and welcome to the Alexion Pharmaceuticals, Incorporated Second Quarter 2018 Results Conference Call. 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. Go ahead, ma'am.

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

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

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

strong bottom-line as advance position made this term. performance executing diseases. the pleased in our significant to Susan, drive long Thank in and our our morning. joining key you growth delivering We're quarter, rare sustainability and XXXX you, objectives very continue on leadership We've us to thank for progress we second with top-

Metabolic contributors XX% and deliver, including Complement growth. to franchise to and PNH, portfolios volume all-important of aHUS, with revenue growth growth our XX% metabolic this of continued and our gMG year-over-year First,

our meet best ambition to launch. track on we're gMG Soliris the of with Second, being

be patients, we continue add encouraged, U.S. the We new to as particularly in

capabilities gMG the our apply towards will launch. ALXNXXXX We from

data Third, and collectively ever launches are comprised the the PNH of ALXNXXXX approvals. regulatory program, Phase our U.S. Filing planning on completed submissions switch regulatory positive largest also based the for PNH for on and next year, half from track X clinical we've studies, EU and year. naive this trial which Japan the second both in pending is first

enhancements. began option Therapeutics to study pipeline and trial leadership. strong on continued a potential In key become an addition to launch as the evaluating an John powering for quarter as with forward in believe and WTXXXX, potential our call. we ALXNXXXX Pharma. a to the completed provides second for the the important development rebuilding And Wilson in care the our treatment plans other later I acquisition Brian patients, look for foundation of With providing Fourth, and objective. collaboration is to now we're well Complement programs, pleased Wilson's announce our disease. asset we of to with for extremely ALXNXXXX full superiority I'm provide standard have Phase Complement detail III are we the new differentiated a PNH expansion the

new our headquarters pipeline we guidance focused we our opening the year. we've on and lot addition, great quarter second global delivered continued of a building fifth, remain of out course And and the compliance of actively bottom in in updates strengthening momentum. corporate updated half opportunities Clearly have the are to build the provide and this our this strength reflect both the again the performance In other top financial we very to additional the strong evaluating is our accomplished year, to and this over first culture, on of line. And a including our Boston. and of hope once

patients lives turn quarter we the the As to families by Paul to to on call the Paul? and over mission rare updated diseases. results now do will discuss our provide transform following so always, affected financial and their second that, will guidance. devastating to by With our of I and details

performance Thanks, revenues increase quarter. Ludwig. billion, with Metabolic This strong the in of franchise. year-over-year, color on more in happy in $X.XXX XX% was reported we performance. a to an the by financial of slide I'm Starting driven provide our X, quarter strong Soliris total

WTXXXX gMG X share formulations by We program expansion to expense addition driven XX% investment, development our delivered in for and per non-GAAP control. operating the margin Phase to strong top-line in quarter, the of anticipating largely into earmarked by margin second spend Our ALXNXXXX subcutaneous XXX R&D half increased This earnings to lower back in in an achieve operating XX%, growth operating XXXX. operating XX.X% trial, We're business in of activities. of year, driven goal strength, of above the was non-GAAP a points. is owing expansion basis margin

As we this to press we're business. continued in XXXX our full-year momentum reflect our guidance morning, reported the in release increasing

X. an growth of FX were XX% price X%, of Moving product of sales to tailwind and X%. partially a offset headwind slide Net driven volume by by

XXXX a rest order of markets related first $XX be approximately revenues the of also quarter QX. the were impacted likely quarter holiday to This the July an headwind tender Second of compared favorably in world ahead by and will United included States. X benefit in in timing million orders to

$XXX X, slide of was Turning in million quarter XX%. year-over-year revenue the with growth volume second Soliris to

markets to order timing approximately included as quarter results and quarter due first tender were orders XXXX, of million to Second impacted the compared $X of ahead by X. of July favorably the rest in mentioned, world

and QX, growth growth reported slide remains key of year-over-year. of million we volume a revenue XX, Strensiq to driver growth, Moving XX% in and XX% revenues $XXX representing

XX% revenue The growth second to the We a ahead volume and revenues approximately included over million, due X million growth holiday. year. Kanuma quarter reported timing $XX of July order $X year QX of XX%

slide on P&L the to Turning XX.

R&D Therapeutics quarter lower XX% was with in of expense was EPS by $XXX Spend is Non-GAAP of Wilson effective in $XXX During tax asset spend and supply XX%. driven SG&A timing $X.XX, rate the research and million, costs. We GAAP GAAP Wilson owing reported which acquired of share million, or was IP acquired growing the the non-GAAP of than $XXX revenues. workforce quarter lower of R&D was the orders, $X.XX, earnings The XX% the development million to of inclusive value lower clinical XX% Therapeutics acquisition. R&D revenue. anticipated, year-over-year. connection in-process program or per was expense. quarter negative second in-process non-GAAP was non-GAAP

facility. the In June, we for $XXX credit prior $X.X We securities. $XXX revolving and restated loan During Wilson. in the the quarter. term million amended against in cash paid quarter, with revolving billion we cash and a agreement. generated facility the and credit billion provides drew The $X.X credit ended of excluding agreement free cash We a marketable flow billion facility for million $X our approximately QX new

So let's growth updated our billion, range increasing now guidance to between midpoint. revenue XX, at turn represents which guidance. $X.XXX topline outlines financial a XX% slide which the our billion year-over-year to We're and $X.XXX

guidance $X.XXX the growing over billion is to guidance our from revenue to increase Soliris, contribution gMG. an due billion, For $X.XXX prior

share to is representing XXX additional operating inclusive XX% This programs a XX% this Strensiq. now will of two-thirds business from over of point XXXX. of WTXXXX, expected Wilson is margin one-third guidance FX in spend includes rates. R&D range for grow providing is to attributable $X.XX operating using a well Non-GAAP tailwind and EPS basis Soliris development. between share, forecast XXXX. XX% XX% business. midpoint as be to to forecasting GAAP $XXX X% which We the expenses. expected growth $X.XX roughly Metabolics, FX XX%, our per operating of effective half this be per ongoing itself profit headwind as of and non-GAAP XX.X% the increasing earmarked the unchanged Metabolics represent to We're at is as momentum to GAAP be This Strensiq of to now acquisition of year-over-year. $X.XX XX.X%. a expenses year-over-year. year. and to rate XXXX see expected reflecting revenue and be to earnings and million to the to We non-GAAP now non-GAAP expected estimate range, ALXNXXXX attributable is restructuring billion nearly is the $XXX guidance, XX%, is is share. XX% midpoint expansion We is guidance, previous to for price related We're Turning of in revenue current tax in continued million, of approximately to $X.XX to dollars for per XX% a and XXX impact At million inclusive to to spend with margin this revenues approximately our $XX be

we the key that we call as well-positioned really With first second continue the on turn year, and of five the beginning to I'll we're year. initiatives all laid half as over half, the to proud the of John. we're the the of of at execute this out into strong move we progress

ALXNXXXX Thank have ALXNXXXX trial readouts. you, PNH. as you upcoming we particular data our a WTXXXX, with significant advancing Starting with slide pipeline, of and Paul. our on in made first XX, indication, and We've initiations see progress number and

second and as priority our to U.S., the with quarter we regulators of we we voucher, Europe, where forward in planned the and look year, review a As in in for this approval applications. used review working filed they

half second file this for in approval of to track on remain year. we in the regulatory Japan Additionally,

our now ALXNXXXX early to PNH. HUS, to is atypical study, second complete in plan on us following For submissions regulatory report we track indication, enrollment in X our putting HUS atypical approvals results and Phase in XXXX, file

optica are now trial Soliris for final the disorder, patient that just spectrum complete. visit neuromyelitis is and to and to we PREVENT or the the occurred, study report Moving last relapsing NMOSD, happy

bolus time for was to is, remaining the therefore, trial evaluations, Given the come study analyzed. primary final all relapse, patients data in a to of in endpoint first large the and be to required there

are a in completely patients We to all later results investigators study study lock with database and year. that time. to emphasize working and the like results diligently are months I'd Alexion this sites remain and at blinded coming anticipating now this

ALXNXXXX to ALXNXXXX multiple formulations subcutaneous dosing. treatment raise to the plan for year continue for designed additional initiate patients. By Phase to we once-weekly with with bridging this the We provide bar study end options subcutaneous X developing of a by

PHXX Phase subcutaneous could Halozyme's Pending year. week we called co-formulation, and technology or Trial In next-generation be CTA, co-administered in study ALXNXXXX ALXNXXXX plan dosing for formulation initiate addition, and with ENHANZE other this to X monthly. subcutaneous later a potentially the reduce once this a every will Clinical to filed EU Application, or

Wilson Following the we of have in second additional acquisition Phase our WTXXXX. X now completion asset Therapeutics, of quarter an

atypical and adolescent arm, hematologic codevelop patients Complement X parameters. We single pre-clinical CPXXX, This disorders. CX ALXNXXXX response, the a measure a for targeting endpoint renal inhibitor of collaboration complement Slide combination study a began a primary adult the with also and design Pharma for inhibitor, HUS. a is complete in Phase study neurological depicts with to development in being is a of important with TMA multi-center both which improvements XX

at following PNH We will number kidney a function. The approval. look secondary be submission also endpoints, filing sBLA of an including

to powering of we care Wilson to slide demonstrate the Phase Now regulatory plan applying to another turning X WTXXXX look excited profile forward to believe new and for expertise X study patients program clinical with and differentiated which We XX. standard bring to a a disease. now We're by has Phase our to advance superiority. potential

evaluating potential liver generation study. to further differentiate XXX, including We a additional biopsy are data also

and enrollment approval expect increase changes required for X now the in one-year we the With X XXXX. timing data to the to Phase regulatory modestly to Phase with plan trial, file

CX central barrier that slide the co-develop began nervous CNS, of primarily inhibitor produced for complement produced the collaboration pre-clinical has a to to subsequently decrease resulting in CPXXX, the the a and liver It is with binds neurological membrane to believed Pharma CX and the enter quarter this in disorders. or of is CPXXX CX potential we XX, to Turning complex, in brain the attack CX to peripherally crosses inhibited MAC. blood formation this system. level the Complement

strong over this look to these programs preclinical While I forward out with quarter. updates year. to commercial we pipeline, to Brian? to throughout With for and is on providing a that discuss the clinical the BD strategic research you complement the our internal collaboration I'll programs the focus fit call our further Brian with highlights on our building strategy continue stage expertise. turn

launch I'll and John. of our update our XX, overview start Metabolic with providing which Soliris our gMG to on an pleased XX you, an on additions building including identify franchise, cover launch new slide we years in Thank on Starting our performance. aHUS. we've our Soliris established that by our States then report we number and on over foundation, patient of PNH patient XXXX. the continue and patients new net to in PNH the with starts saw in market, I'm since United the highest portfolio

aHUS, becoming Slide an the Soliris indications in to revenue to family our core XX addition continue able growth this of In we launch into our Soliris grow our of which is provides with further on patients we've PNH MG forward. increasing and and growth, U.S. update contributor going in to expect an MG, been quarter. to

Given our adoption will to MG and PNH aHUS. launches date, believe our trends outpace we in

month. We number the continue each increase treated to of patients

the the on we XXX therapy. source, including U.S., patients had of of enrolled in end in June As XXX one

slide to XX. now Turning

in in access commercial lives and confidence than U.S., at Here patient. of MG. ongoing I'd efforts highlight of the that treated gives This of more XX% XX% trajectory one coupled the physicians our covered with expand have trend, us to now now prescribing Soliris

of launch progressing of in we and continue efforts Germany, While to learnings ahead see from Japan, launched we've was our and due new expectations, focus in to sales to U.S. uptake, refine part, the the our is clinical expected experience in region. U.S. which largely Germany. our we based, the our In Germany trial large both on Japan continue In and slower initiatives lack

on force gMG of neurology neuromuscular as the inhibition educating benefits including specialists, with junction sales of the as of complement on dedicated disruption is complement-mediated Our the well neurologists, Soliris. actively neuromuscular in role

another with of significant this growth Strensiq and $XXX The demonstrated performance. We highlights for our nearly slide our be is we the expect opportunities excellence, full our Metabolics quarter, launch XX. reported revenue now Moving its now $X.X see in revenues to million year to ahead. powerful in Strensiq billion, starting franchise and which on confidence example sales we continued trajectory

expand with population continue we elevated hypercholesterolemia need NAFLD are have transformative thank new funding LDL target patient on levels. XX, lab of their to countries and to ALT securing having tireless focused Kanuma medicine. higher five testing such those likelihood NASH, slide at access team, on to expand at and I an three want diseases. bring agreements global therapies and LAL-D, our familial to proud them to that Looking our to efforts enriched additional to in for as in across I'm remain for very We this who rare patients

more and ALXNXXXX ALXNXXXX in I of program. excitement the you take Given launch our update on interest as launch as and detailed the upcoming will development now and PNH, ALXNXXXX a well through John plans broader the John?

Brian. Thanks,

first take the how how ALXNXXXX ALXNXXXX meet programs. As standard-of-care value ALXNXXXX will proposition broader elevate our work opportunity physicians, needs discuss our intend patients to payers we approval, of of we we to to development the the the and and suite expect toward with want we

in and studies, studies, who evaluated patients shown program secondary complement as primary ALXNXXXX received noninferiority and XX one two collectively XXX largest the ALXNXXXX. recall, slide PNH more of X PNH across may ALXNXXXX in demonstrated you one a Soliris who In patients endpoints. inhibitor ever in never stable had the key As on XX, conducted, program Phase patients than to X comprised on and these all both Phase clinical which the of Soliris program's switched to were

and XX-week period. and sustained was immediate entire treatment observed complete Importantly, throughout CX inhibition the

cases next-generation were in how there more had of few program. programs, ALXNXXXX reported and of cases ALXNXXXX no of exposure safety In far. total, Phase been of into over either X indications with breadth the expanding studies, addition, of thus shows additional in ALXNXXXX meningococcal the In studies and the have that reported Soliris. with the There XX profile than further to XXX standard-of-care modalities we plan no consistent we extension patient a work infections our multiple advance the and years. new Slide next years across with entire the have

and As atypical second our ALXNXXXX for times are mentioned approvals. for infusion progressing our plan reduce parallel, next higher expecting approval year, indication, of in the in we're half mgs results approval first and PNH patients. ml, previously, XXXX concentration to to first for for Phase per PNH. ALXNXXXX In in formulation, following pending X we file We order pending XXX our HUS, launches

for subcutaneous we multiple Moving to plan with options programs. XXXX, patients beyond further expand

We subcutaneous X the patients of Phase provide to potential ALXNXXXX option opportunity have for and later treatment with this initiation an needed XXXX. a bridging to our once-weekly in another study year filing

in continue or IV dosing file XXXX further to the planned or trial to initiate and to also every XXXX. PHXX extend to program, with in We year, be our X monthly. a other week sub-Q once progress later ALXNXXXX could is second a coformulation either ALXNXXXX potential early Phase the gravis ALXNXXXX, We myasthenia interval of which this of late that intend to

you broad of are the So complement the to discuss options raising can back programs, innovation in portfolio now and call ALXNXXXX's to And to standard to bar treatment dedicated care. Brian further are differentiated we I'll of as see planning across turn the elevate suite the Brian? to a profile. provide of

Thank you, John.

XX, slide support of attributes we to value proposition. the highlight Moving compelling believe ALXNXXXX key let that a me

populations. as across John Phase X very highlighted, the First, generated clinical given patient two has trials in diverse data just ALXNXXXX profile, strong a large

eight-week with burden the inhibition will for we weight-based believe patients. And ensured reduce Second, dosing third, we in significantly complete treatment every complement all dosing patients.

differentiated and payers. strongly many physicians, The profile the needs of XX. slide to now Moving addresses of patients

CX treating is the three saw our controlling an of reduce ALXNXXXX's all the including important of of the to results therapy. of of protect our breakthrough burden prioritize LDH deviations to all Phase the burden but hemolysis. which ALXNXXXX studies. patient number the treatment. reduces In strong clinical the disease PNH in system. Also, inhibition payers clinical ALXNXXXX's convey We total weeks complete from Phase patients its which desire to transfusion minimize the disease interest indicates on critical across the significant the could the no hemolysis. With First, with plan the Payers one have hear measures over with eight studies extension patient these every partner the treatment. of that breakthrough burden continued trials, in from totality eight-week ALXNXXXX ALXNXXXX levels, includes avoidance data We costs. extended dosing infusions, and and key their consistently we studies, which and the look could data, in to X community measures X in will totality of treatment physician patients Payers disease several to cost clinical proposition. strong and predictability mind, globe value of at

While we're weeks. of suggests supportive finding eight surveyed strong prefer PNH market and our still generating adoption. of engagement two-hour physician extensive Over infusion XX% research, patient every initial patients ALXNXXXX's

surveyed more of had PNH of spontaneous treatment product launch. dosed Additionally, than saw eight Physicians two IV to in surveyed one a of strong quarter interest two an trying over an initial launch. patients after opportunity weeks shortly months patients, interest every their thirds within switching in for new suggesting

also facilitate all than to patients target thirds potential a to initial conversion. to patient We receptivity ALXNXXXX. us shared in would their two the of rapid some read of PNH our giving existing ability market data initial positive more the view physicians ALXNXXXX, switch found We confidence or on today as

to Turning XX. slide

experience patients of we with new to are our care Given standard to of of ALXNXXXX. Soliris, the a in launch uniquely positioned the complement with space deliver decade-plus

pipeline launch to options Ludwig additional striving patients to elevate standard and Ludwig? options. turn now the in potential continue bringing I'll indications, each address to we patient, closing for and as early as back new our treatment PNH in call of further to ALXNXXXX payer remarks. We programs, to physician care. the needs, well plan advance of to family subcutaneous of our growing pursue delivery a and towards With these charge XXXX

Thank you, Brian.

XXXX team's reflecting Let have as I year Thanks In by around And long-term would work to progress the to I'm only for families to the the also we and me in established very foundation future. the the but momentum. here, towards most we out strong goals. team patients With a commitment value. our importantly, Operator? world that now call can to and they that, employees play on strategy steadfast making providing on by our the will close to possible. for shareholder when tremendous world, questions. patients we we first thank summary, rare our have well And our see I'm not their positions our past our critical therapies like quarter, open the past talented Alexion this you laid pleased to deliver and families. life-changing around disease with inspired their made role our for

question many to limit will turn you our that the of to people now line once portion please stated. ask We possible, In your To noise, order call. any mute your your on to background accommodate question-and-answer prevent place question one. been as we as has please

first comes from Geoffrey Leerink. Porges from Our question

Your open. line now is

accomplishments operating Thank this results you of congratulations the excellent much, very questions, and on and all A quickly. couple quarter.

gMG ALXNXXXX Thanks. growth us First, the growth about if, give high for – just contributed Paul, meaning to. U.S. from infusion about you John, and a right underlying all more what reduce experience wondering what in sequential And you trial just to, then, current the if of might is, formulation bit rate implied what me now concentration it with in the that then, $XX though ex-gMG. you've give observing it time would number wondering on could and looks in just sense as could that had clarity clinical what if and go this you're U.S. the the about of And million the little business a that's the formulation,

two approximately regard thanks. every X and , John. infusion the times eight to in With So, the weeks. with This is current given formulation that's hours, program ALXNXXXX, Phase were Geoff

approximately newer minutes. concentration hope per to one ml, XX reduce XXX hour, to below we the formulation, mgs higher With that

Thanks. Great.

patient below kind giving XXX close bit Geoff, the your gMG. you started in United quarter We're question, from in numbers that of lion's know, The gMG the little – so comes the the do we as numbers of but pretty ended the States, math. a United in not at XXX business. the part of you're can second on share States United States. We revenue the you

implied kind terms of In of last the over about underlying these quarters. of talked growth, numbers we've number

very of dynamics quarter That's biggest aHUS modest you for out volume of, and all kind saw If do try in on on quarter-to-quarter to, we PNH a strip apples-to-apples basis, growth underlying second and the the in last high we've the changing single that digits. the a what rest the of couple I'd in the seen world. that attenuation quarters. say is factor from is

As key before, of previously it what we've growth, that's we geography out lowest pointed the was the a as driver see growth. of got amount

base quarter every bigger. Paul, And our and is bigger

Yes. Absolutely.

Great. Thanks guys. very much,

Thank you, Geoff.

Thank you.

Our next Matthew from for Morgan is Stanley. question Harrison

open. is line Your now

questions. the the how swap on maybe these about patients just will Good some you of trial, thanks then you a you you superior the and quarter, tender the that And that need additional quarter? enroll morning, were Wilson Paul, maybe me. talk more second, like could next of what to biopsy, I two including idea taking about result. in us orders Thanks. endpoints, drive everybody, just so And be. give how Great. many for guess it you sounds liver an us you and remind for should what that that here large received need reverse think to think

breakdown. basis the geographic to in $XX this – in Soliris I'd the of of quarter around characterize magnitude the you sequential part first sales quarter is the from benefit would I second – question the point tenders from Paul your for million. a Matt,

rest-of-world hard see world headwind which itemized the we as the July You on rest see a basis. is that of to the by the that. as these do can total of predict in headwind, sequential product. to well markets, of extremely in – doubt, expect many is we No X It actually timing

the excited with own WTXXXX have don't momentum want far. so we is The to Matthew, Phase all, to that's we're already achieved of And as in regard Wilson X know, first and underway, disrupt our program, you been the already program, to portfolio. really

With so sample is standard can what corrected relative to patients which superiority endpoint be for at possibly size of that to from to biopsy optimize We try of the non-ceruloplasmin we're care terms actually primary regard study endpoints, XXX that trial we're XXX label. change now position to be to the sites, was evaluating are. get ensure the will the other we communicated keep primary as feasibility, a liver in them in to the for they even et them more, endpoints So may least going would And cetera. originally increasing to patients, we copper. the be separate that the

is we objective to that Our can de-copper the show liver.

regularly the additional data. better do we saying, a objective. the regulatory, stronger payer from there's And payer's a objective should as and John discussions. one-year So there's do The need was us studies label, help with to get and

the pathophysiology uniquely to underlies profile, differentiated the the which Yeah. to underscore liver, that We a is product this will this disease. progression the biopsy is think liver and study help end-stage to us of liver de-copper the effect

Thank you.

Thank you.

Terence Sachs. from Goldman is question next from Our Flynn

open. is Your line now

Hi. Thanks Good morning. questions. for the taking

is slide, have docs wondering your of feedback then of that and while regarding you've value noticed any to they had switch they the are EU that indicated payers U.S. any one third there discussions preliminary patients, a ALXNXXXX? any prefer or two with I the indicating patients Thanks. docs switch research to thirds preference might from can And not market to if feedback you ALXNXXXX share. Just on either of proposition

Sure. for Brian. Thanks questions. both Hi, It's Terence. a lot

well believe the patients, with product able profile payer had with as the as payers. do of we've We been strong of mentioned, pleased addresses, the that discussions that of first many present. very of On all, data to I course, the physicians, as we're, ALXNXXXX, the needs

engaged we're so in those And discussions.

make to a bar ALXNXXXX with of to care. of high standard ambition, Our course, is set the it new

So that has a two-part benefit.

helps initial well-recognized. a as is respect here market initial you doctors, has who as I of earlier to profile of like the value our the adopters, benefits who of making third sure seeing what one And segmentation response. is of and discussions, well all that jump in continue a With make two for see we'll those also that continue kind It potential might patient to to looks space competition. that with do for we'll the narrows in payers, ultimately, target comprehensive we course, product. of time launch, patients. business But full what as to willing you're the mainly the the the our sure of as research ALXNXXXX course see the the little work think bit those noted, those are with that and of doctors early to wait on engagements with Of the thirds

we to talks fast Brian able on facilitated conversion, ALXNXXXX. our objective data deliver conversion that be of should to The to

Thank you.

question next Our Evercore from Schimmer ISI. Josh from is

Your open. now line is

taking Great. my for Thanks very question. much

For the and a persistence how of gravis the give Soliris, adoption can curve myasthenia that...? sense therapy you for us on

you Josh, you. can't try hear again? we Could

Is any this better? Sorry.

much That's Josh. better,

Okay.

Sorry about that.

was I of that ultimately Soliris curve, the might persistence can affect myasthenia other adoption gravis give sense for if us how the you the a asking just some launch of compared trajectory on and to So therapy indications?

with Hey, again. uptake. the demand Brian, pleased front-end, equation, Josh. MG, continued the of on It's we're With I the the as noted to side respect

patients on their mark, a had REGAIN so-called on study, full which at real nonresponders. and also for means as reminder, What is them product seeing for that, launch. than through reinforcement the the positive there MG. positive since quarter who looked we're XX% it Just have early really benefit, patients reinforcing because second to the And we XX-week that we're journey the who it back has only a has of a of were the this less world for about in in the yielded Soliris MG. number physicians were course, significantly is what from And for prescribed is encouraging

than more we're we on, REGAIN continuations study. early encouraging but saw seeing in So generally the

you. Thank

Our Piper Chris next Jaffray. from is Raymond question from

open. is now line Your

Thanks taking the Hey. for question.

the up following you question I research just previous heard I answer that switch. Ludwig, the docs market on So wouldn't of question, the think third regarding

like were dynamic you for jumped think say safety? color that clinical timing there experience. specific that? and it it for you Any the Can some Or with was matter logistics something experience? was it I I clarify of the they Was would heard out waiting or there just maybe a for issue reimbursement was Thanks. looking clinical waiting or help. that

further I'll and Hey, Ludwig any first add Maybe Chris. It's on can commentary. Brian. go

in rare market about having had seen cohort that clinicians. ambitious one As case, comes we'll a this too doctors keep is of conversion. of to profile little visiting I in are of to of research see and work patients the one classically a mentioned, we thing a who And doctors, the have about the down bit mind in more actual conversion when in of had there's diseases, talk their terms is what through cadence it and you to who experience segmentation two-thirds

as ambition more launch terms the of less really of uptake. facilitated after those it here expect go or plays what But The function getting and the And part how you a it it to of conversion make oftentimes Ludwig second PNH experience and that to in I allude just exposure one-third data think out. and noted, we the standard of the is the care and more waiting and is patients. in that's for

launch with We've had and the insights really a over saw of the experience we decades about market excited We're prelaunch. segmentation what here. and lot

high. adopters' percentage is the So early

group for a our good pretty have strong and we will a have see. of stakeholders, And physicians fast which we bar has have of is is in this also And time. we need a that Soliris followers, of group we're position who here. believe product pretty is believe what very Soliris although you the fact each So believe good that of then high a but you favorable we a we value proposition

Maybe I'll dynamic eight-week talked dosing market interval cohort of who just that is well versus focus to of about a will the will breakthrough comment is which our expect more hemolysis. I Chris. we ALXNXXXX the two as get as see as the point be data, about we'll who doctors and digest Hey, one the that – obvious measures, we as research, need add LDH weeks, another that as – the And transfusion well. avoidance one of our the totality the further

you. Thank

is Rama from Our Anupam JPMorgan. from next question

Your now line is open.

for Hey, guys. much the Thanks question. so taking

at get faster. are on hearing institutions much. On so field patients this? in have Thanks gMG that about launch, natural therapy the you talked the guys efficiencies on What anecdotally could you

who by that's the this that's you're settings. initial we've for most we're is time and respect in will of beginning signal the been been phase academic of trajectory. out in some positive in a And what comments, encouraged gMG, gMG their again. had uptake in Good have doctors Anupam, experience speak has my have to in with so improvements responding neurologist, initially had And with of in we're important Yeah, to it's of patients over depth. to launch. reinforcing that And less breadth community institutions. well actually, play But the Brian. terms see they're the with we enhancing And With expect which continue at improving, so uptake. that the then both to noted what that as is also general, of the prescribing seeing seeing progress really signal Soliris with I you

taking question. Thanks our for

You bet.

Thank you.

from Meacham is next question Barclays. Our from Geoff

Your line is open. now

quarters for quickly. for congrats quarter. so, starts of same nicely. ramping level saturation that we a kind level you. Good kind quarter? of of can this This the really you growth-driver? Thank terms I'm or to curious, both previous Geoff. underlying what are and expecting true in as steady In And needs you if is of PNH Jason point? Thanks growth the our Kanuma then, And about forward, Strensiq achieve still morning, And aHUS. are Wonderful. on taking was on is when? call and seeing happen. that everyone. had think Thanks Real double-digit moving the kind you that curious, of Zemansky the Kanuma, And a talked question where I'm point much. same there And in so tipping is

of that Jason. part Paul. take first Hey, question. is This I'll the

asked on. I it think Geoff had earlier

saw regional in underlying a growth off balancing for have driver. really You was basis very you see the continue that, so with growth but a the PNH previously Kanuma. quarter is had patient line strong PNH being rates slowest it do in aHUS heard, business seeing of the may an we rates expectations. That all noted, geographic big We're we turn Brian, of as perspective. much on that We're Brian our base, rest-of-world, kind not we to probably envision together. additions, growth I'll growing apples-to-apples a the from to just larger United get States. which of high-single-digit And you then, when

the again, a Yeah. want Maybe just team. say, asked go Kanuma, since question of could to the I be numbers I bit before the you prouder not little take to an behind opportunity and

where terms as what that expert really you're underlying products and seeing as and the you're team focus results. those to work well in the is of in needs. that's growth the is day in diseases what think out and patient I they seeing in we And a the day deliver,

this really that point that for slower with So is, the sure are testing these getting as populations, seen, first the right but lab Kanuma, we believe about all, on do increased volume Kanuma. as possible clinicians group. an convinced easy that a not motivate secondly, make we per testing accounts them. ramp, With focusing we strategy by quarters, actually of one will And enriched as would for this few of you've predict do it's of it's in talked se, a believe the tipping with we're a that, do I see at stage increase proud as But really and to that strategy. on, right I'm we to and set we've one testing, up the in to

force and day, those that passion see and the find with the to part Strensiq of as the it's the ticking PNH those for seeing same end clock aHUS. Kanuma in gMG is We're we our mission and Yeah. At in and sales our patients. of patients,

you. Thank

is Nadeau from Cowen from question next & Phil Our Company.

now Your open. line is

Good my morning. Thanks question. for taking

I prior to expected of a willing curious if that conversion, I'm and to said a Do Maybe What we're in U.S. two Ludwig, reasonable, convert those you'd you third or of convert ALXNXXXX, be ALXNXXXX the question patients conversion over you the aggressive, Thanks. of of on end quantify rapid patients, XXXX could you Soliris think Another specifically, a from what by that. in response to proportion question, conservative? PNH as to thirds strike and period time? estimates projecting about XXXX. patients,

and here, for in going lot question. jump this to So I'm line a mean Brian. thanks I is the -

the Phil. way, hear to from Great you by

I the appreciate stage. We're any Yeah. our certainly up not do We've targets preparations. provided launch at question. ramping in conversion this

that couple ALXNXXXX's and we As that feel do will I've with support rapid conversion. said differentiated times, profile, of market the believe in we totality course, a data of

think And conversion. it stage there. is this leave So we'll to the I in launch our objective at be for best-in-class facilitated preparation,

my taking question. for Thanks Great.

bet. You

Thank you.

Our from Marty next from question Credit Suisse. is Auster

And Thanks ALXNXXXX Credit Suisse the Your (USA) - for differentiate you any Can is program work open. are XXXX? interest conversion relative line question, pediatric you reasons guys. PNH that lastly, why Hey, you is help of aHUS just in doing gather might look indication? population ALXNXXXX Soliris question. relative Marty. then, expect It's different aHUS to the what the do proportion currently And think could data clinical that Martin to in and aHUS might how LLC housekeeping now in start the versus Auster that there outline product, as taking Thanks. you adult? think Securities then, you

is Marty, John. this So

on of in profile fronts have We our a that aHUS The as and completed differentiated and head-to-head highlighted. arm endpoint. was that enrollment have study, know a Switch you been which have response a data already believe we studies PNH primary study Naive has TMA Soliris at with single is So of program both XXXX, the beginning will estimation were. program a against the number complete

have to. So will data we'll only not be Soliris, historical With to compare it head-to-head.

that direct differentiation program. in So that it head-to-head opportunity for won't have

It Credit question, more adults. benefit pediatric to there's different Is ALXNXXXX's is, the was mix pronounced whether there think versus profile to in whether Securities versus your benefits just in (USA) kind adults less Marty, if any population wondering and Suisse Auster conversion of I any, relative the clinicians curve yes. LLC that related frequent find to any - then peds Soliris, And the Martin aHUS? infusions PNH. terms look in relative might a would you potential other of is and And

enrolling. underway age, have I program And we what is adults is also aHUS say can course, So and patient have and the a for that's pediatric with less average the of ongoing PNH. that than adolescents, is we and study

over to take end. to Brian there'll would think I I eight-week that would infusion, patients that on differentiation. to it advantage that be received So comment of be turn able younger can on be the better

out, it'd We of expectations see of in the how don't course, of in LLC data, We Securities the split, have on play But have the have (USA) Soliris. we'll don't Martin Auster with the to the see terms to we wouldn't we world - Thanks. precision expect but necessarily see, Credit to wait between the Suisse two. Okay. difference for and a data. real

you. Thank

Our from RBC. is from next question Mackey Keith

now is open. line Your

Brian, Hi. Thanks one Maybe first. taking question. for the for

of all wondering into broadly, but if not your to extension expectations just the help to was could internal much. sort Soliris in internal there out have patient us are more a biosimilar continue. been very mentioned any you why one that patient changes and one chose wondering then, recently. with Europe you for what those potential Thank expectations I continued study. You just And if

question. So this is first John. that I'll take

anything their of from with taking the experience that. satisfaction, the and randomized In into study. for was not have extremely to the to phase this the choose to product of reasons do First for It personal of didn't There's of patients logistical during more it's our an various patients all, case, very all remarkable unusual to it go study. extension understanding virtually do a decision.

elevate care really the leadership question, sustainability I is long sustain discussion on your standard biosimilar Yeah. a ALXNXXXX, just our believe, try my our in piece. answer leadership to of maybe position that that of feel We we to important I'll maybe good With position the respect complement. it most raising had we which, with to about can

the what we in platform and strategy we're front, a the the on Japan nothing prosecuting both biosimilar discussed Soliris, EU. for new have same strong IP U.S., from then And We before.

of that enrolling. actively is we So X we Phase data any seen not any aware X trial not have Phase are and

you. Thank

question next Bank from Our Merrill from Ying Lynch. is Huang of

is open. line Your now

Thanks for of total The about my non-GAAP a down to Paul. percentage Hi. a question. has SG&A come XX% on continued for as revenue one basis. morning. Good to taking Maybe now first

going the you wondering, about just and do Pharma improvement for also that or side, the you could is forward for talk quickly on So collaboration? research development Thanks. indication more the SG&A potential good potentially is And proxy that Complement can happen. then there a think

Yeah.

– I'll that, the first of take me Let Ying. part

about but was a you I garbled, little as of think asking a bit think percentage were SG&A sales. I it

Yes.

Yes.

SG&A big Obviously, So and into that is that on of is of broadly. the next year expect top giving or to leverage going leverage. lot there we're continue guidance getting line. expectations year leverage a kind I off Without the after,

the with doing with including the And in ones the range Pharma, mediated evaluating generated regard know, of complement been to we've Complement even not in profile. attack antibody a inhibition. We're injury, that neutralization antibody and now CNS, in some Because already out it's in believe characterizing of sort circumstances as and terminal its a the stage. we vivo would of of an with is CNS-related lends you inhibition this some CX animal preclinical that biology conditions, complement experiments to peripheral of it itself to

coming So as the which take we'll range and broad, over quite share the it. is year to may direction guess, we I more,

take three we'll questions. more Operator,

Thank you.

Citi. Karnauskas next Our is from question Robyn from

open. now is line Your

my Thanks progress. and on congrats for the and guys. the question Hi, taking quarter

wondering, that I in my the to operating these was going near guess I pressure you trials of and So help two. One, question think could much Kind question. margins, margins put all I us is a how term. on On talked follow-up Paul. a operating the it's know And last about on for things. you're on or lot authorities you them about and And and going reimburse for aHUS if to them telling asking the guidance. and we're year regulatory haven't a going similar maybe so also be ALXNXXXX second given in is to like ALXNXXXX, to about MG pricing. think ALXNXXXX you for question will have you long-term doing just

on that table a up so you or could possibility You conversions? companies Is and multi-drug speed Thanks. are other doing contracts. the

Great Paul. questions. to tackle it. Okay. I'll Robyn, this is try

set nearing we XXXX. an We're actually financial the ambition margin So full XXXX what look, on year for pleased nearing operating that guidance. we're with very we're a out as

in So year. it pulling effectively, a

is have we we degree to growth topline bottom I and as we next about expansion. that think the it operating double-digit to that which continuing to year, achieve through. implies leverage believe of to margin go to The want we'll year kind following into as in to sort the way line, think continue the

As kind it get of aHUS over of ALXNXXXX, we time, happen programs some effectively That and pressure, stage noted, do doesn't them. PNH I But a we with pressure doesn't trials of longer that get as to even see upward overnight happening the and potential sight. a in different that happen. from period if there's we downward

the pricing, So company. With you margin of committed to still the growing broad we're respect asked for kind of question. mean, performance a kind I to

would be it is problem. very think I complex. It a great

country. a it's by get this. do I As specific kind think we We'll premature Brian noted, just to as country tackling good on it be it'll too And but opportunity. it of broadly be see

you. Thank Great.

Thank you.

Our next question is from from Oppenheimer Hartaj Singh Company. &

now is line Your open.

of appreciate Great. been not diseases just some There rare companies been aHUS where sort have question. in on a I have ALXNXXXX. of question the in view these trials Thank where optimal the regulators one-arm had have a maybe trial it. sort quick you. of I had the there

supplementary Just and any Thank to work how regulatory out. will BLA that your interactions thoughts you. on PNH

estimation X they single-arm trial an with and So HUS. embarking trial head-to-head atypical interactions alignment Alexion got having before program PNH had a and for Phase extensive with on in authorities regulatory ALXNXXXX in

very will guidelines it meet for that we're So confident regulator's registration.

U.S. and and of we're Japan second already planning we've this the the in EU, filed half PNH know, year. for you As file in to the

question. Last

you. Thank

Suneja is SunTrust. Our last from from question Yatin

open. now is line Your

for Hey, me guys. Thanks squeezing in.

gMG. or Soliris, paradigm? Just that validated I the about Thank you possibility thinking, mean, could thinking in Is front the complement have indication? how that treatment a move you that you. candidates maximizing this CX, perhaps a to just or broader question value there the on up is other are pathway pipeline given of

question. that it's I'll just I start hope Yatin, Brian. saying Hi Yeah. by Great so.

these for towards time, patients in have, course we a on earlier is to Our who long behalf ambition many therapy. of of continue cases, suffered progress that

we're U.S., in of treatment launch XX we're of noted, about that FDA clinical the quarter in mind, Now, Solaris full approval because, keep the still REGAIN in neighborhood of the population. years. for inertia, I terms type as was this MG in first in And second the in new

So and so therapy, to comments lot the perspective. there's reorienting treating a plasma an he of on. and of ask relative maybe is I'll clinicians to IST education to But IVIG, from way a John if that wants R&D and exchange ambition, different

Yeah.

I that activate antibodies mechanistic a we think know perspective complement. with from acetylcholine receptor patients

here journey for further a additional as patients an unmet the theoretically board upstream across would So so continuing innovation be and CX as mechanisms. amenable the inhibition. new to gravis, well There and need in large myasthenia there's is opportunity

going call. close to we're the So

all, of want thank First for to in. everybody calling I

really their we and to delivering quarter said, patients are our our employees this we with what in As and pleased families. are

for So calling thanks in, everybody.

participation you for and gentlemen, conference. your program. today's thank concludes the Ladies in This

disconnect. now may You