Alexion Pharmaceuticals (ALXN) 30 Jan 202019 Q4 Earnings call transcript

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

I would now like to hand the conference over to Morgan Sanford, Director, Investor Relations. ma'am. ahead go Please

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

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

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

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

morning everyone. you, good Thank Morgan, and

take in Achillion performance, our a successfully year Pharmaceuticals, XXXX that closed of represents to step on diversifying our brief like an which we we fourth announce review business. Before and would have full our quarter moment acquisition important to I

to with we portfolio, this and clinical two our danicopan XXXX. stage assets Through acquisition, had

range of to assets excited development rare the the broad are Factor for to of D these Achillion and colleagues Alexion about our to collaborate a We thrilled welcome opportunity on diseases.

have our goals. objectives, to is all U.S., we three Japan. PNH, the the EU delivered is the Japan and our now now anticipate surpassed our in Germany U.S., our performance, XXXX we in on of the ULTOMIRIS well conversion cases this progressing ULTOMIRIS and HUS in leader markets, and largest key Turning launching many in in and year. The market

continued We franchise years, pleased gMG two are the uptake also NMOSD. very SOLIRIS the in our growth U.S. our become in with franchise, in of volumes. has patient neurology launch of just with largest In by the and over neurology

ULTOMIRIS and SOLIRIS, to patients the is NMOSD by by ambition number and quadruple treated U.S. MG XXXX. of Our eventually in the

for deliver Our metabolics expand and we work access patients. to portfolio continues to HPP as growth, strong LAL-D

have XXXX, made formulations combination have progress new on have our ambition a XXXX. earnings our delivered financials, until for in new and the XX now through pipeline an from great assets, XX% launches end and non-GAAP we XX% on growth of revenue And growth new of indications. Importantly, and again with once

clear Slide creation. for value to have we a X, Turning strategy long-term

HUS, in establish will three geographies. market leader our SOLIRIS move ULTOMIRIS PNH and First, we as key and past in

Secondly, we into PNH franchise our larger beyond HUS diseases. will CX and expand rare

with ULTOMIRIS parallel, treatment have In to we indications. will new planned two and subcu indications for nephrology innovate We including options. four in neurology programs patients continue formulations six new and

amyloidosis. Disease few over pipeline launches, a the this have transaction, of range including beyond have broad line a portfolio pursue sight development the we Finally, this disease robust Wilson and treatments the we rare past D, of to With Achillion indications. our and clear Outside blockbuster have to multiple opportunity CX. example diversify will we is Factor years, built of effort. AL most of recent potential in for

future. the continue significant We capacity to diversify our in financial pipeline to have

we leadership beyond X, are ULTOMIRIS business you business, addition In rapidly in our patient diversify On to moving indications. expand complement to our in evolving is bringing see SOLIRIS. addressable Slide to approved our can is our external population. two assets for

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Yes hope you us hear Hantson. can I technical that is had okay. hi, issue. guys a Ludwig this We

of will So and will Slide we're going there. I it X do restarting, what is, to on instead take we start from then

a to for turning X; clear So Slide long-term creation. we have value strategy

First, leader key establish and and we our will market PNH in three move as past ULTOMIRIS SOLIRIS geographies. in HUS

Secondly, beyond into diseases. franchise PNH HUS larger expand and our we CX rare will

two treatment indications for including options. We innovate indications. programs continue and formulations planned we and with have ULTOMIRIS subcu and parallel, In nephrology four new to six neurology patients will new

CX. we have this beyond a our example Wilson Disease pursue With Outside and transaction, portfolio opportunity development AL to recent of sight most Finally rare line indications. multiple past broad this will and of effort. robust we pipeline few clear the a for launches, disease range over have to the Achillion blockbuster is we have of years built the including D, potential of treatments diversify Factor amyloidosis. in

continue future. capacity in significant We to diversify financial to pipeline have the our

addition our population. to we patient In and bringing assets to expand addressable our complement in diversify to business, leadership evolving our external are

we moving which high formulation, X, approved transition only to across two is to and Slide additional and see for SOLIRIS. will shorten concentration can our On indications will you neurology in six development indications, infusions beyond business is a rapidly nephrology. This XX-minutes. for ULTOMIRIS year,

a once-weekly, our subcu plan formulation, self on home-based ULTOMIRIS launch offering patients Next option. to year, administration we body

oral diseases. XXXX of opportunity From in XXXX each significant and many indication with treatments, have next Our transform with see Achillion's for and Factor proximal generation selection regimens, we standard will assets. platform. we complement care complement-mediated offer these optionality subcu patient expand D of there, improved to immense dosing for assets, We

XXXX, see solid fourth you for excited and deliver pleased for we top priorities quarter which creation as line against we Again, that the on I'm our again, provides very our strong delivered strong build bottom execution with X, growth once on year, XXXX the foundation Slide to have continue On full and to strategy. our value and our a successes.

over call now With turn I that, will to Aradhana. the

Slide strength franchise, and neurology we total Starting an was continued fourth of XX, ULTOMIRIS approximately growth reported launch. XX% in billion, revenues our Ludwig. driven This core increase in businesses the quarter year-over-year. $X.X with you, Thank of by

Our portfolio. prior build margin non-GAAP year, versus driven of tax R&D and EPS as and growth increased further rate. Non-GAAP development year-over-year, XX% strong spend, XXX our reduction driven by by a XX%, basis was was advanced top operating growth line lower effective we primarily representing points $X.XX,

volume net our quarter Moving to product in primarily by growth total markets. Slide driven key patient XX, were sales fourth

X%. fourth ULTOMIRIS revenues conversion Turning by primarily the approximately offset were growth revenue XX, fourth growth revenues, to XX% in partially States. $XXX in were which dynamics. were Metabolics growth. Slide million, includes now by the driven from million, $X representing atypical SOLIRIS year-over-year revenues with quarter quarter in the of SOLIRIS HUS $XXX was year-over-year in billion, quarter gMG ULTOMIRIS revenues fourth contributions the United

in audit. rate continued quarter certain of tax $XXX revenues. non-GAAP Turning from the the XX%, expense approximately benefit XX% one-time to of release the was reserves the was SG&A XX; million including the P&L to and non-GAAP state conclusion or XX% of quarter, R&D an events, $XXX The was related tax during expense million or Non-GAAP effective on to Slide of revenues. income

adjusted fourth earnings GAAP ended fourth billion cash reported $X.X XX% the marketable the Achillion quarter in securities. quarter EPS share with for transaction. year-over-year. non-GAAP We $X. and were is approximately per growing $X.XX, of not We This

our for financial to XXXX guidance. turn now Slide I'll XX

revenues billion at $X.XX growth the XX% this are the We of to and $X.X midpoint guiding billion, total range. represents between year-over-year

NMOSD, SOLIRIS and billion our in in SOLIRIS ULTOMIRIS, ongoing revenue of $X.XXX for This SOLIRIS of gMG, billion. our is continued launch For HUS. guidance ULTOMIRIS PNH launches and atypical assumes $X.XXX to momentum and for the

the guidance revenue sustainability of strategic to million includes for weight $XXX XXXX consider dosing. our annual metabolics; SOLIRIS associated as is STRENSIQ is important and it and decision in ULTOMIRIS, given the with based STRENSIQ relates conversion access, to In $XXX KANUMA. cost per patient. the and it support to for both the to dynamics Turning the million from This beyond, to to U.S. impact pricing

patients as patients increased move ULTOMIRIS dynamic, majority the dosing. course revenue expect XXXX. XX% having plus due to PNH impacted now benefited consumed annual by over There lower of of in PNH starts the to converted be to We from maintenance dose. treatment ULTOMIRIS of this vials patient, treatment per a of to the We is each cost when number dose loading benefit the patient loading during

per atypical other indications and compared maintenance and HUS to cost development, dose for dosing variability loading ULTOMIRIS. In consider important patient to SOLIRIS for and both is annual to due we also see every eight-week a quarter-over-quarter It lower will dosing.

will fluctuation out annual quarterly even basis. However, an on this

XX.X% have included Non-GAAP of going to summary this be presentation, the consistent operating a reference, versus and and as We progress pipeline. appendix of XX.X% and to this XX.X% serve forward. approximately expected provide between Non-GAAP expense of a dynamic, represents a with XX.X% R&D to is slide to be margin step-up million build and between the further is year, a our $XXX and out of to expected intention revenues, revenues. of prior in

Non-GAAP is be for XX.X% milestones BD increase full reflect Clinical previously also and line for announced particularly program leverage revenues late-stage potential is of to increased the in spend growth. year XXXX, program XXXX. to for and R&D and includes and planned expected SG&A costs spend, expense top transactions between development, from collaborations. XX.X%

been XXXX items. approximately the be benefits, certain XX%. non-GAAP Absent non-GAAP to benefited We one-time tax XXXX, effective expect and the effective XX%. rate one-time rate non-GAAP would XX% tax In rate our have tax between from these

We non-GAAP outside tax U.S. the effective future, of a the as our tax expect in increase regulation to rate changes result

increased an midpoint $X.XX This X% to future impact of be reflects approximately recently reflect but expected $XX.XX. to financial The between and pursue. closed that not EPS $X.XX. guidance may our expected of $XX.XX we year-over-year, increased any does as prior is is EPS between acquisition, compared the Achillion R&D non-GAAP tax a and year. EPS spend, result M&A the to is of be growth GAAP and Non-GAAP rate,

revenue we a see XX, strong can have on XXXX, have and you maintaining Since a we track non-GAAP margin. delivered double while financial total of EPS Slide record competitive, execution. As growth, digit operating non-GAAP established

revenues, our non-GAAP to biotech and line with percentage XX%, have increased We our continue spend in invest within to R&D XX% programs R&D a peers. as our in of to

With to goals. the momentum on our the deliver current positioned are we financial well of business, XXXX

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

the report on can for expect weeks Aradhana. months, you anti-FcRn on development program, XX, studies, our Phase In the planned coming interim to On development data III and have from CXG. stage weekly interim we XX in danicopan of study once clinical from programs body XXXX. subcutaneous II We and an see ULTOMIRIS you, data current now Slide Thank our Phase our update portfolio.

acquisition the in to months, we as excited integration. We're look forward on and providing coming of about the additional detail the Achillion embark

reiterated ago, from execute portfolio. launches ambition our weeks we few current to XX XXXX our a Just by

programs, these stage development, and summarize On R&D and population. Slide including see you XX, which addressable can our highlights, the estimated clinical

an CX Together, neurology tens atypical We ULTOMIRIS PNH well are and ULTOMIRIS into the expanding to our population and presence are indications the our patient programs five of nephrology. present beyond opportunity advancing by and HUS across thousands patients. additional expand of treated business,

been the has minutes reducing and and are concentration, patients, infusion innovate key We time which proposition value once-weekly a high to a received ULTOMIRIS, compelling on formulation. subcutaneous well continuing believe body XX those by and in of stakeholders, physicians with ULTOMIRIS other to

our addition In with see opportunity diversify novel programs, four indication assets. business stage additional ULTOMIRIS late we beyond to CX expansion to

chelators, Wilson's XXXX standard-of-care affinity which oral with rates, ALXNXXXX XX,XXX Our due for poor an higher burdensome once-daily Disease compliance superiority for trial dosing fold and is III have remains than copper ongoing. therapy, current regimens. to Phase

expect the top of We of on next first line readout and in half completing the the enrollment are verge year.

for in asset to late coming transform plan amyloidosis AL program AL Phase this initiate We amyloidosis, CAEL-XXX II/III for disease kappa potential We months. treated see and characterized the months misfolded by amyloid, stage of Patients deposits approved to which treatment an the agents, and not change, in lead a to survival failure. lambda currently resulting chemotherapeutic with a organ abnormal post rates for diagnosis. only amyloidosis, are light can of are XX median a

renal and collaboration, the overall rate, XX% supporting organ data for showed to response addition efficacy on our in endpoints. rationale cardiac Clinical a

look function, an primary quality serving life of at Phase cardiac endpoints. program II/III overall Our patient secondary endpoint, imaging, with will survival

Japan Japan. year, is agreement address license Last small with in molecule, transthyretin ATTR. designed and is to of has AGXX Pending commercialize protein, halt the potential plan AGXX cardiomyopathy year. we stabilize we extend and development and a later disease a progression. We misfolded root AGXX to discussions, Eidos, destabilized develop AGXX the to announced which ATTR into regulatory program this TTR, to for cause believe

patients Phase patients for D reported Finally, last extravascular in II with see with the extravascular data positive in hemolysis. medical our in subset we conference year. small acquisition Achillion, danicopan Achillion for are danicopan of opportunity excited PNH We of PNH and its a hemolysis about Factor platform. at

danicopan for II weeks, best additional see a twice We broad class see coming in we opportunity ACH-XXXX, of and in CXG, Phase expect range and treatment daily as oral Factor the D interim for data and in in great potential rare diseases. PNH,

excited forward updates, progress the of opportunity with to potential these expand to look the We about are year. significantly we XX number and as treated through patients, you launches the providing for

their they how we Slide to within our to to III Moving and assets. this CX PK-based an weekly use of flexibility will ongoing in believe we ULTOMIRIS leadership, their Leveraging left, is Phase our XX; body manage our next HUS formulation patients in atypical on Starting with lifestyle. further diversify subcutaneous in have disease the with plans for choose trial. expand device, to PNH provide wish WestGen on generation the the

expecting are launch the second with a in data XXXX. quarter interim in this year We of PK potential

the initiate a body have for this first unique treatment larger subcutaneous mini is ALXNXXXX of opportunity to At of see XX ALXNXXXX. number tailor-made asset a our CX a year. We we our bi-specific rare is evolve and next we kilodaltons, disease the only terminal in administration. in convenience with to indications Next, ALXNXXXX inhibitor. ALXNXXXX designed half proof-of-concept options for opportunity complement internally study and subcutaneous look

basket our living assets with is ALXNXXXX our this complement-mediated allows opportunity additional program to with Phase subcutaneous for a look PHXX trial Alexion ULTOMIRIS disease. for as Finally, dosing. recently rare patients We hyaluronidase, offerings II start three renal an of providing progresses. forward disclosed ALXNXXXX and expand to which bi-weekly Halozyme's and our these Together, updates, co-formulation for plans represent to

Our organization. of years, two the in R&D proud development undertaken portfolio and I'm by half entire and incredibly the has a hard work grown last the all significantly

quarter. over turn that, to Brian? I'll With the the to commercial provide Brian call highlights for

John. you, Thank

the unprecedented seen Turning data and establishing the PNH Slide as in to to ULTOMIRIS is XX; conducted. This value which first proposition, compelling the due in clinical strong from in inclusive market leader program we've ever most progress include part -- largest PNH. large

be trials two III in criteria inclusion patient of representative real the broad world The the study in Phase population. would shorter PNH population,

we requirements. and dependent transfusion absolute with baseline reticulocyte Specifically, count patients, enrolled no independent transfusion hemoglobin or

have because XX% bone aplastic to included which also or is bone patients marrow a marrow with of of history prior We anemia. failure failure, XX% history critical, roughly PNH patients

ULTOMIRIS As of leader in this XX% converted largest week, patients ULTOMIRIS Monday countries. XX% of we've three of Japan, in and Germany PNH to PNH market XX% making in our the in the volume U.S.,

launch to strong atypical is HUS the in also U.S. latest ULTOMIRIS a of in start. off Our

curve is conversion line, tracking still point, it's conversion early at in the same the While days, PNH since launch. with time

since largest and our in patient volume, now is business neurology achieved franchise Our two this just years by was launch.

made the have quarter On with treatment the continue Slide U.S. and gMG fourth gMG to in SOLIRIS. we gMG We've broad NMOSD our presence can NMOSD launch. in XX, exited and patients X,XXX our for progress significant SOLIRIS to with access with on you see patients advancing

is Our strong patients a relapse-free of underpinned sustained at out data, with years. XX to showing remarkable Phase three weeks, NMOSD launch III by efficacy XX%

educating We're and the severity difference making preventing NMOSD the payers MS. between on of objective all NMOSD progress and relapses, attacks, the of

we're and SOLIRIS NMOSD. policies been and these efforts, result of a adoption coverage both rapid, gMG seeing NMOSD has for in therapy to adherence payer of As strong

ULTOMIRIS infusion. and XXXX, deliver potential in Looking late population an every to of ahead, XXXX treated With ambition we're on or well five U.S. early positioned years. the as eight-week our within next launch quadrupling to our NMOSD patient GMG for

provide administration. on with the who planned prefer another simultaneously once-weekly, treatment patients, formulation, important IV home will for to launch or self subcutaneous option based formulation body Our

patients, unique serve Our believe a effective population can highly more SOLIRIS space, target treatment a represents severe and where option. gMG uncontrolled and we this ULTOMIRIS is as then

believe neurology which work both continue our target and rare I'd inclusion team, their excel X XXXX a to the In deliver in to enabled our operations our SOLIRIS thank disease dedicated launches, hope ambitions. our and with we take multiple for trial. us to serve. is mirrors organizations, on dedication, global to our population like NMOSD, our moment hard we well patient bring has brief and positioned criteria organization commercial global With Phase commercial to patients PREVENT to

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

Thank there look to you, is what Brian. this XXXX. proud year. Once again, of I'm delivered and We're to on forward very to in XXXX, the well in positioned team momentum build our much further

laid have by programs out and look for to market CX, nephrology, PNH in planned in diversify continue opportunities in presence business as clear and long-term CX. shareholder We establishing to a our including and leader strategy, expanding deliver HUS, ULTOMIRIS beyond to neurology our value,

Importantly, changing unwavering diseases. on we focus and to living rare maintain our with deliver our life to advance to mission people therapies commitment patients our

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

from first comes Our Kasimov Instructions] question JP [Operator of Cory Morgan.

open. is line Your

just a line. on for guess to I guidance XXXX, better your drivers I behind top want sense of the particularly the get

the just conservative, ULTOMIRIS a of are maintenance other that also surface pretty more factors this the function on I'm assuming important the it patients this that dosing dynamic missing? Or year? On are looks scenes is primarily behind pricing of there

is, you're ahead. answer Yes But Aradhana? right. go The yes,

amazing BD EPS top top XX% guided all On So XX% amazing line XX% XXXX, deals, all, was in year an targets, had growth, first to growth. we have growth, of six XXXX. so our line exceeded we year. an XXXX conversion

going So there here. on that are are few dynamics

majority great on now go there will will maintenance and in lower we now patients of impact conversion an from cost that's to revenues, First due SOLIRIS go we XXXX, already we as dosing, XXXX, treatment of into to the annual be had to PNH side. per had all, into ULTOMIRIS the converted, -- because patient, of have as

just a not dose XX% ULTOMIRIS. do HUS first patient starting a two, we in and there the year to atypical There, for lower lower is have in treatment annual patient. cost, fact, the side, the XX% price annually on the per we're benefit. There treatment launch On cost year, is there loading

standpoint. a that sort also result, growth. a from dynamic some mitigated revenue This is extent a headwind neurology As our to of by is

by we out of number four know, times you the ambition neurology, our patients for As put having XXXX.

seeing on volume So neurology side. growth still strong the patient we're

high and grow we're atypical and HUS also to single-digit as seeing growth patients, addition, business for In well. our metabolics PNH continues

the all these impact of it's top mix So different factors that a line.

the On guidance. other impact factors are there bottom line, that EPS the several

is up increase XXXX. It's dollar $XXX substantially. have R&D a a see, heard As you its in or of can XXXX and going our that clinical many about basis, you've did spend about, not which we million on programs XX

the includes that a we of addition, spend close spend R&D the In Achillion the have, also the of as will result transaction.

forward. In the announced, milestones R&D that the BD pay already expect transactions that spend the as transactions, we includes those we've and programs to move those for addition,

see between you on which the is rate, tax basis, expected XXXX to on the addition, a in XX% that XX% In was and or XX.X%. midpoint, XX% non-GAAP be

XXX change from about points basis XXXX. that's So

of line. some factors are those the impact So the that bottom

Okay.

that Does your answer question?

is does. helpful. it you color much. very very Thank The Yes

We'll the question, next take Okay. operator.

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

Your open. line is

guys, Good the a have morning, couple just of ones. I thanks question. for quick

For Brian...

better? hear just Is you little speaking you? bit, up its try. a mind very that difficult do Geoff, to Okay, let's Yes.

Okay.

see maybe Thank where forward? applicable? the between Ludwig, announcement ULTOMIRIS conversion are wasn't -- biggest XX% the and was nuances further you and there from and Elliott, to been differences on if respect or between target between going conversion, opinion strategies MG, the since the Brian with sure curious are -- you. SOLIRIS. dialog just NMO the and then, there I between broadly between the if PNH aHUS, and indications, you if with highlight and there just for down differences And road So have

Brian. it's Geoff, I'll Hey start.

first business XX% On the your of the and HUS, all, the of comment applicable yes. PNH base conversion, atypical to answer broadly is on, on is our the

the have We same ambition.

our made over are PNH, Of largest we've on we in and we've reported as three markets, PNH mark. progress with the excellent course, XX% now

leader. So the market ULTOMIRIS is definitively

different a it's terms more dynamic because is HUS a Atypical conversion, condition. in of acute

ULTOMIRIS of start start is in an they there on the and you as who formulary facilitated ULTOMIRIS, they setting, SOLIRIS. then, same So just is the dynamics of is, soon many and ambition. and to but for patients, awareness But as hospital part part will inpatient may availability, opportunity that again, of discharged, are have patient actually conversion

we're continue you years around the gMG about as And SOLIRIS, it's to and really with the neurology, we your depth asking making And other make we're launches. in as NMOSD. ULTOMIRIS are between about to and and counting, prescribing I two you're both the Though half here talk as pleased guess U.S., gMG breadth too of different very question progress of premature because there in was and in with know both is neurology. with progress prescribing. of well dynamics

began of we -- of NMOSD, journey year, as In very and much year. is combined X,XXX in launch gave the on track, of the The last the that last part we middle patients. of numbers end

two our with So within gMG that four at months fed progress really of five the has we've six made, and now. years be times, from NMOSD, plus to starting years ambition point and with

respect of have Geoff, we we continue constructive With a our with so your with Elliott, second to shareholders. question, dialog all as have to

carefully we you all in and dialog of to Elliott As our you. started with listened know, XXXX very

is we that, the believes need we more believe much next question? the to management Operator, to especially we is and strong I long-term stock Board, on a executing our There that to given undervalued, team, we have add can so a value. have take in that focus create will not that also continue strong can and shareholder strategy strategy that We -- that including that execution that. the

next of from question Our Porges comes SVB Leerink. Geoffrey

is line Your open.

Couple thanks. questions. Okay, of

to it a so is guidance, in going you're to of me though just saying SOLIRIS. sounds underlying there ULTOMIRIS strong is flattish sort trend Aradhana, be First to obviously because that as the on down,

carry for just take I and if revenue XXXX. QX your rate guidance So forward, get then run to the it I

I down shift, actually then the your want is the they Meaning other XXXX, because even QX And aren't clear? of to to trials or fall telling the sounds going XX compared So of you you're to which risk program, to go some I question, by being just by run sure it is and another that's see clarification possible, that XX or dose us what as your that communication ULTOMIRIS make rate, launches is though that how Thanks. strategic about by as will want those, successful, to the ALS Caelum wayside add programs ensure to that high the understand you are you just such commitment? if clearly if and deliver think that? XXXX?

Sure.

So can first then question I'll second question. the address and John address the

So I that down. accurate think to assume it's ULTOMIRIS revenues actually going don't are

revenues a We up go reasons. for expect ULTOMIRIS to still of number

First still of XX% is long our and market go, to major PNH on only of around three all, we've the geographies, way there in side. converted the a say

Secondly, a we HUS, see. that conversion atypical that's ULTOMIRIS we and just and started launching dynamic will

a is and of you the as dynamic. volume pricing there in can as mix both appendix, the Now, price, well you've -- see been

the annual as the well. businesses conversion very volume some there we on will as be per on still both of headwind, the as lower -- growth result obviously be franchise, grow neurology side, of expect price drive to by the the metabolic balanced side, on will to cost and SOLIRIS the well a So strong continue still those That patient.

Yes.

for We have -- $XXX the million quarter.

we're up Brian and the to $XXX that, that HUS talking We no XXXX about do was is a run rate picking million. plan much almost Geoff. and we than is with It's of have in to sales U.S. better fact which So in mid to class. get best ULTOMIRIS we we've year. approval seen the this think a is good what on similar PNH, of HUS before Plus, track to HUS that European conversion

as globally come month, will that another launching we country ULTOMIRIS. that's have in every So Plus

to going grow So ULTOMIRIS is substantially.

on your launches? XX And your then, to respect with question

Yes.

Geoff. Its John. So Hi.

concept think think it's de-risked, I ambition. far. Many disease of which believe we Five of our launches on to the areas ambition. ULTOMIRIS, of We mechanism. are data proof based launches is related the have so are is clearly we established we've in those where already XX and those an achievable

to assets, are think relates Factor other five The two D, data. of supporting and a where those new we danicopan strong have we

we to And regard the we continue play. and of that plug development, as envelope, in bringing be we indicate, business you kind will think with to assets if to will, and able you new press

more as innovation. achievable, one we we well haven't we internally, so well, -- as highly potentially, talked opportunities other that's as think about, and external those or have of really off, And it's through if then fall both that

your that Does questions, Geoff? Next question. answer

question next Raymond Piper Chris of Sandler. Our from comes

Your line is open.

for the taking Thanks question.

R&D, Just your EU. Maybe question can could XX it it's brackets maybe for some quantify maybe versus made there's assumptions are those of Europe quantify of like noticing ULTOMIRIS APAC more the -- world on the Slide in can around And you if you just any impact for guidance slides, lot of I versus about or ULTOMIRIS? Russian a impact? milestones you. maybe, put some And QX on guess in APAC in and the Thank XXXX looks in growth ULTOMIRIS the rest or biosimilar specifically, you also talk just a the world for rest around or you SOLIRIS? then what that you just maybe

Russia. I maybe with start Yes,

you moving fact, the of Russian how matter expect any might works, but -- business market CX not Russia, a forward, out business really. of ULTOMIRIS you the is should As the know in in answer Russia

second your on loading? question fourth APAC Then quarter, on

Yes.

we the as you strong by that see, in launched very uptake. Japan, was it's and there really PNH APAC So ULTOMIRIS quarter driven fourth Japan,

the patients I in that was for the difference. the talked loading We and have volume with shared numbers about and PNH benefit that given the pricing past, the dose you

So the numbers. that explains APAC

we have then a And question on the milestones?

we're owed. and and so is and milestones forth, Yes, there'll be and Affibody both I on we've not. Dicerna much public programs milestones made partnerships, versus as how down we progress, much various impact breaking XXXX that Caelum our don't how those transaction progress and year. given, be, also includes and spend can million sort plan the $XXX to then Achillion danicopan increase, you of that And this of estimate both the would forward think

will we take the question. Okay, next

question of Evercore ISI. next Josh from comes Our Schimmer

open. is line Your

for factors missed And strong addition expected? was is Thank question. with for this SOLIRIS growth NMO have And might I so, the you. point might the but SOLIRIS? Japan, bit of of indication the a Thanks have -- little given label I the expansion, repricing above if does drivers, in that then SOLIRIS there for where new it, U.S., in the to still contributing but other for taking any how? change rule, the price some performance going

that Josh, as Hi in I pleased we've mostly with SOLIRIS launch nicely. and story that have you July, began progressed the really growth with neurology, the U.S., in think very it's With the NMOSD, around which as of again a what well and Brian. we're gMG, has are had

SOLIRIS and for -- questions is goes well. back which also your earlier as We and to ULTOMIRIS, this more

In identify to all low double-digit continuing to see naive HUS that conversion and growth And the atypical as talk as continue we dynamics about, patients digits well indicated, as we've pattern. with we well. new PNH addition as in we that high-single

So it that's feeding additionally.

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Harrison Our Morgan Stanley. next from Matthew question of comes

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has you second And this advance Hi, initiation a I'm to your Matthew. of wondering versus a in prior now Thank any Phase Phase this for FcRn III? XXXX. follow-up is you. expectations? this gMG which Kostas a delay II on been I whether question, need study half to what based do question study study, there the have the on is to

you. thank Yes,

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had we've that last that we issue CMC a You may year, recall addressed.

II delivered. volunteers hemolytic initiated that We higher program drug for the new formulation paused with reinitiating a we was that's same formulation in subcutaneously and reason. have which December, in with IV the now began this product the Phase anemia are healthy concentration to have been also quarter, We

position gravis, be to to need So in myasthenia launch dose And then trials trial. ranging And that Phase ranging do additional those type with further seamless we hemolytic a later year. dose pivotal we course with to some regard may will be this upfront and anemia. of II/III programs there, progressing a then complete of would

additional no the So ahead. in pressing program. We're delays

Next question.

Robyn Karnauskas SunTrust from of comes question next Our Robinson.

Your line is open.

to about, way or ability How quickly the had as that converging Ludwig, And along How you question. that, out set price to target we going with noted. that you've for quickly, have how my taking the you've with color XX% we capture on so just terms in for model competitive do landscape? still thanks could How that XX,XXX think already provide, to you. any for you eligible go that, could could correctly? about conversion talked just that goal. the XX%, are a of given at out originally then population Hi, slow with Thank you a thinking forward? and about you that bottlenecks impact figure to MG the

Hi Robyn.

patient for ULTOMIRIS addressable one Let me the on gMG. the start with in the opportunity XX,XXX approximately first

uncontrolled, of all gMG the we are which segment Phase the talked market the It's a patients, really as X.XXXX narrow that larger occupy with SOLIRIS study. call let's first relatively, to times, So gMG way III the we've is, evolving And aligns patients. more it many of severe regain about see about continues population. pivotal that

last but two has We that limited are that spot the label in X,XXX from has the for been stay really patients, by the years, sweet that way, not a SOLIRIS. in to perspective

As is we the the forward, have previous larger regain, based up and design not segment opportunity such launch team for expanding was cycles that as for high therapy of we that the ULTOMIRIS. see of see the and move it put on we that IST trial John that of as that ULTOMIRIS, with opening burden a into space

we're we've the as have for we'll offers, price ULTOMIRIS flexibility stay consistently those we'll, price, that opportunity, point unfold, eight of one neurology we indications mean, that that your about align I to ULTOMIRIS. path. have to pursuing so aspect with is that we Now, continue said, on announced, that will assess. And But we we price as to we've and volume maintain value the said

ambition question conversion Your dynamics. the was the We maintain same still XX% continued second our two years of launch markets. around within of

We time, it's bottlenecks The as that from a a worldwide, atypical treatment centers, is moving are to well takes so for a with penetrate. largely them with of continue excellence largest us volume centers lot about as function of customer that. Germany, track with well HUS, broader called real segment, we to PNH, time Japan. talked We've just bottlenecks, of to wouldn't markets, higher we I U.S., the the pride of and and three even that see, on have call with only

operator? Can we next question, the take

from comes Mohit question Bansal next Our Citi. of

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for thanks Great, taking my question.

what CX? would it of make Thank as you. you and you terms or seem to want ahead not could profile clearly potentially to XXXX, the So help in agent, the viable switching alternative toward monotherapy potentially a a of [pursuing] us danicopan see could like with of doctors well please lot, XXXX pathway XXXX strategy, drug, frontline just the But a as is monotherapy. which understand,

Sure.

data extravascular that now are in communicated the has has of the in there at and got II pathway, all, PK III is half that's XXXX hours, committed plans forward has XX% study XX the patients with with characteristics. already longer December, being an about we completed progressing better that a same we activity move better to It II publicly has with planning hemolysis. XXXX, first clinical Phase more ASH against of Phase to life PNH inhibition study with development with PNH and So pathway. Achillion shared At in time, Phase also a alternative the half-life, ongoing which than the that

EVA. expand So in give potentially to greater allows order we're potency with that to it those excited opportunities about it's us frequently, beyond into that compound, and the really new less

So CX that now, it, there also monotherapy. II but program Phase only inhibition, of not is on looking going is at on top a as

with opportunities operated implicated, has about we're haven't would I pathway then beyond rare where opportunities disease where say, to the in treat we disease. more excited very patients that exciting been the in, areas, are alternative lastly that PNH additional and there And

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the We question. last will take

Kennen question Capital comes And from last of MacKay our Markets. RBC

open. is line Your

progress throughout been switching help Hi, pace the morbidity? New should for PNH can me and and differences how switch on execution understand the beyond we Year. in thanks a into XXXX AHUS has us Brian, PNH, thinking disease for in presentation Maybe be and squeezing in question versus U.S., given maybe of the you about the in the congrats in phenomenal

Hey Yes. Kennen.

Beyond phenomenal, I wrote that one down, so thanks a lot.

Put that in your review.

I the from But we on in ULTOMIRIS feedback patients, the cost payers. certainly from PNH favorably the of economics earlier, noted as dynamics, same, course, the more of versus The SOLIRIS. profile are atypical and HUS and atypical an with physicians, dynamics even is same annual compelling fact therapy between get play different. ULTOMIRIS the in as noted, from had Aradhana HUS out And for of

inpatient, So how are terms we're I But think what we're dynamics we ambition XX% going of to launch, different see tracking. months outpatient just in pleased same a the the with starts. couple of and in are

the So question. thanks for

take have here. want meeting to I topics it the I two Okay, perfect. I'll Operator, from that with. the close

The first the state is topic of business. our

one update The IP. is second an on

to R&D that formulations Then margin have healthy a -- our organization. have industry. the we our our respect by We volume healthy why XX talked way is growth, growth With attractive believe is moving for increases. price indications, is we have that's we fact top-line through forward. driven healthy -- to a business business, have business. an and about that by be we products, to it new volume very the and we We operating this not within about In I ambition that's should innovation. say we believe drive We and pipeline biotech a launch new very our a XXXX,

believe good We in play healthy the our a we feel We all XXs, that's come about in, is we are now mid margin so reflected this, guidance. to around from really very this of and lower the space XXs. operating and

IP. as topic, is second The I said

have update. an I So

seen SOLIRIS, used XXXX. method U.S. Office is of a patents. And that, new has U.S. in through patent providing the covers SOLIRIS, And with allowed the the patent a some PNH of treating for new you the additional Patent might which protection patent of have methods

XXXX, those none you with remind all HUS have the you, challenged. patent of SOLIRIS, It's to in have details for we what's a been that two patents existing going of on also guys Patent Just method-of-use know important in an the covering U.S. Office. and which expires

enjoy we'll dialing you you. of Thank progress and really in. I the that, the call. Thank am your close excited making With will that day. you we're rest hope for about the

this and conference now for participating. Thanks concludes call. Ladies gentlemen, the

may You Everyone disconnect. a great now day. have