ALXN - Earnings call transcript Q1 2018 | Alexion Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to the Alexion Pharmaceuticals First Quarter 2018 Results Call. Today's call is being recorded.

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

Susan Altschuller

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

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

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

Ludwig N. Hantson

joining and Thank for thanks morning. this Susan, you, us

key made and year to the sustainable, long-term have growth. very we pleased objectives with the drive the are to We to start deliver on our progress strong

of metabolic strong in-line to growth complement a growth, year-over-year of volume X% portfolios, continued grow including business from we growth revenue First, X%. delivering and revenue our and

launch. best in of U.S. launch to being Soliris the our with strong we're ambition meet patients a gMG the on and our start, to Soliris is for gMG off particularly track Second,

by later important in announcing John strong and an by regulatory offer Fourth, fifth, submissions updated Third, Once followed Soliris we now Soliris Japan from PNH EU disciplined reflect a effectively plan business with in announced announced Switch study. Phase and step guidance of set year. results today the performance tender the data a in showing acquire to in robust tender offer have first the to by and later we X will strength the on mid-XXXX, pipeline. through marks broad to Phase believe patients our patient provide the which We from that in delivered large detailed rapidly financial met we in X XXXX Wilson our the Therapeutics plan safely the Switch in study development clinical call. And, the XXXX U.S. very and from the on and bar again, consistency can PNH Based totality Naïve move second positive to data for a and data high strong, Therapeutics. the executed we profile a rebuilding we our transition and of XXXX have Wilson the study. XXXX. studies population, business differentiated of underlying have

plans patients potential approved it patients, robust real-world we weight-based of care decade dosing, for will to six, all experience a differentiated to rapid this efficacy and key payers. of of with to impacts numeric XXXX. first of by standard with across become could enable regulators, slide our Paul? our profile If call XXXX quarter potential The and on believe pleased This, show two to impart conversion over guidance Moving of will data trials we're global will results details to every quality-of-life eight-week new from results the financial over and the the secondary XXXX. for dosing discuss and favor physicians schedule, with an to benefits in that, primary and patients provide the optimized X updated endpoints. has economic XXXX along turn year. With I Phase and Brian meaningful to more now leverage Paul the for PNH.

Paul J. Clancy

Thanks, of X%. Ludwig. revenue share slide first delivered XX%. X%, the growth We Starting per growth driven volume X; quarter, of growth earnings with in we delivered by non-GAAP of

financial approximate expansion preliminary guidance announced the an well offer momentum reflect margin. coupled as in the expense operating of tender Continued core the led for top-line, on point to non-GAAP control, We're business as the with strength XXX Therapeutics. updating impact to basis the of Wilson

America U.S., X, slide Asia Net FX by and sales and sales softness patterns headwind volume Latin the ordering driven quarter growth product net sales of the in by first by as as XXXX. were to the in tailwind sales first well growth offset a in million. to product X% were The X%, related in of comparison EU the quarter Pacific, partially of by driven product in offset of XXXX Net Turning sales price of America. to were X%. timing $XXX Latin decreased

and first XX, volume the a benefit $XX of from Turning quarter roughly and million the XXXX recognition to revenue million, Soliris tender first certain both in quarter revenue year-over-year growth deferred orders was slide markets. Recall timing that of non-U.S. revenues of X%. $XXX was from the included

from In approximately and million. addition, other trial were $XX QX headwinds to enrollments clinical XXXX Soliris

volume very the $XX first provide an start Brian in growing to was Soliris a the ramp-up gMG this growth the launch underlying expected, for increase contributor to an the full its exciting these adjusting the revenues. from double-digits. quarter and enrollment. quarter, strong When due us off for It's million in and the a greater first and is is in context. In of launch low approximately to items, all was QX As PNH aHUS will

first volume QX, a realized million benefit in growth $X XX% States. As $XXX XX% shown in a a key reported XX, quarter, in change driver the revenue due a we in slide representing million Strensiq distributor arrangement and We the revenues In year-over-year. to remains growth. of United of growth

revenues revenue approximately achieved growth of tender revenues million, was $XX year-over-year. XX% growth previously QX we at Looking $X quarterly by markets that Sequential in benefited QX growth orders million. XX% by and representing of impacted and deferred volume timing the Kanuma,

and million $XXX and expenses. XX% non-GAAP Turning owing P&L margin million was R&D to the $XXX was low and the expense on non-GAAP XX%, the Non-GAAP XXXX revenue by operating of during of growth leverage. slide revenue, delivered we than expected in to XX% was a or XX, driven of SG&A unusually transition operating in R&D revenue. lower efforts restructuring expense quarter, QX or

non-GAAP tax XX% higher, R&D XXXX, of $X.XX, GAAP half rate expense year-over-year. earnings expect from the ramp in which quarter of second We per $X.XX. reported share pipeline. especially effective R&D the was to XX.X%. We ongoing the the rebuilding per of expense driven The was in QX grew by non-GAAP share anticipated earnings

with marketable announced the marketable billion cash We $XX used we to cash shares cash half approximately Therapeutics. the free to During securities. cash our will approximately utilized securities of flow for and ended anticipate a be XXX,XXX quarter, approximately generated for million. and recently portion $X.X Wilson of million in tender offer and We QX $XXX flow finance repurchase

goal with expect approval, to fits allocation, deal and our offer and to to our to the pipeline. tender build quarter. is capital The in close the approach second the we regulatory anticipated continue the well Following acquisition

guidance trials slide This guidance. outlines of guiding $X.XXX midpoint as to to revenue turn represents XX% for includes now impact the $X.XXX as of We're Soliris our to and assumptions on at Let's currency. price well which of other range. the which for and our expectations foreign the XX, updated year-over-year an billion XXXX total billion, financial growth our

to an in over guidance For PNH gMG. due to prior steady our underlying from well the the Soliris, and growing $X.XX guidance our $X.XX revenue is growth as aHUS contribution increase as billion, billion

adjusting when Our growth for PNH believe planning trials, single-digits, is the planning and prudent other is for assumption. in volume assumption we for XXXX and which high a aHUS,

Turning in Strensiq. $XXX million, momentum million particular continued is $XXX reflected to to revenue our for metabolics, guidance

of approximately XXXX X% benefit. foreign million Our revenue tailwind guidance to or for currency million assumes $XX a $XX

a XX%. will announced is attributable of well as related Soliris as expected offer, our in and price Therapeutics restructuring is Wilson estimate the XXXX, of headwind estimate we addition, one-third and X% expenses. This GAAP-operating In margin tender inclusive to to be X% to metabolics. to two-thirds be

purchase on recall, from in you As expected to the in core an this to of asset. to plan acquisition XX%, representing to the will a now. to pipeline. expenses range, related At XXX the of effective R&D following delivering P&L. to $X.XX year. be the XX%. the to is XX% investing now range this earnings share. be This guiding expenses to operating We're of expected the inclusive share per of WTXXXX accounting is this non-GAAP continue objectives, share to to over expansion And cost $X.XX the additional on execute be to to of represents points turn the an non-GAAP closing, the a approximately $X.XX inclusive Therapeutics. call as year-over-year. We XXX and on pipeline. business to GAAP per treated an rate is XX% Non-GAAP to is perspective, expected expensed expected the to $X.XX midpoint XX%. acquisition immediately basis is of our Wilson the ongoing our was XX% growth operating growth. margin GAAP midpoint points XXXX Non-GAAP earnings excellent tax guidance, QX I'll profit XXXX building expected the rebuilding start for including basis be John of be impact approximately be to per of At will and

John J. Orloff

efficacy open-label, on Patients XXXX these really study X Thank Switch this I'm active-controlled study evaluate stable for with that Soliris in based start period, receive XXXX the Soliris. The to randomized, of The randomized receiving the PNH or XXXX. at extension randomized and a four-week X. having in you, the PNH treatment This is have were patients up in of a which screening two versus a large arm X Soliris X years non-inferiority the Phase profile arm an adult in the X:X weeks cohorts It ratio on XXXX can of every dosing weight-based We XXXX two enrolled patients least data accordance was in I with differentiated three to you receiving a review in two of for beginning are on treated treated single label that Soliris currently today. safety safely report XXXX regulatory with to studies. in from is patients will and and data period in slide XX the is a approval picture study Paul. until who consists loading study with complete regimen strong success. who every a XX-week weeks obtained. now Switch Soliris pleased ongoing to dose treated global of been share Phase transition to Phase purpose with XXX happy and six for safety past or a XX. day effectively Soliris I'm following And eight months. day design after the clinically patients Patients XXXX show of to period were efficacy to were a PNH. dosing study the on were

were represent by forest and Turning effect respective confidence and study The of in data I to the XX% bounds relative intervals represented upper to margin They the lines XX. treatment lower XX the the on triangle. the non-inferiority weeks, core slide pre-defined estimates. plot difference orient to now to the would red at the you assessed like the

the For less XX% of is XX%. interval non-inferiority X%, bound in predefined the change which than percent LDH margin of lower the the endpoint, primary exceeds confidence a far levels,

at also -X.XX% already the percent in normal from You slight a X.XX% see the that baseline Soliris baseline LDH in a to values change levels increase LDH in which of mean for the range XXXX compared was arm. the arm, mean reduction for were

a favored to key versus the for point Additionally, similar endpoints. indicating of Soliris. the We side the right had that estimate XXXX results secondary plot falls no numeric difference,

lower the margins. intervals bounds greater see, predefined you non-inferiority the are XX% all confidence than the four of met as As non-inferiority, substantially

key testing estimates arms superiority. for as hierarchical of point the the XX% with The our in was value addition, four over order to difference pre-specified endpoint not but further allowed tested. LDH all statistical four of no all the percentage and with in endpoints, confidence lower bound test the superiority Soliris in percent P on Soliris superiority which Plan endpoints. a Therefore, X.XXXX. between interval -X.XX% secondary primary change Since we came us LDH In for the achieved Analysis first XXXX close was quite change a key of X.XX% reach testing did favor conducted. XXXX for The Statistical non-inferiority secondary the and

that it arm, breakthrough hemolysis withdrew patient no population, in experienced is study five in experienced and to patients XXXX the Soliris breakthroughs notable efficacy. compared However, patients patient of this receiving three due from one the to who including lack

see XX, there see meningococcal key was adverse on were XXXX both you Naïve and of XXXX had No a treatment-emergent either consistent the seen XXXX and and and observed Turning and No of infections to for studies. Soliris endpoints in were XXXX the the No in that with slide both either compliance Switch slide cases observed side all was for On reported XXXX arm favoring for the from study anti-drug Switch safety across arms. that well-tolerated was in was due secondary in generally patient arm. withdrew no Soliris. XXX% the study. for results profile Treatment to one events. consistently one antibodies treatment neutralizing primary you antibody observed XX, Soliris. the study,

program. We particularly for hemolysis compared rates the Phase across X pleased are with to XXXX of breakthrough Soliris the low

with to key for studies, around non-inferiority of exceeded their summary, and favoring complementary more PNH achieved and Phase than secondary we receiving with world. X XXX scale. margin the the benefits patients quality are weeks confident that every In totality as XXXX XXXX eight the substantially endpoint. of XXXX also improved Importantly, established primary measured the XXXX life results by two each patients numeric every dosed Soliris non-inferiority we've on in data In based of FACIT-Fatigue the

PMDA We and by year. in European which Japan followed Commission the are in preparing the regulatory now submissions to the later file to submission intend FDA midyear we to our

developing disease. chronic to Turning in This biopharmaceutical Wilson estimated tender disorder disease on a XX,XXX we patients WTXXXX a is the toxic offer month, first-in-class that and of rare are have a devastating especially patients. development high and in action standard and in copper become organs, limitations treatment. agent current Therapeutics, copper the to addresses liver now for to to the patients Wilson genetic cause Stockholm, development asset which in binding business treatments is of the developing is the a the disease, the liver, disease. serum Phase and treated is the innovative States and copper the accumulation vital that expertise slide has has in look based Sweden and roughly acquire of nervous the underlying potential activity to central the EUX. Wilson It X a our United addresses WTXXXX, Wilson for affinity clinical announced WTXXXX of forward XX. accumulates in company This that with the regulatory the care brain. mechanism system, We patients which applying that can namely, our of with diagnosed unique for consequences

and complement a pipeline and to and objective is Looking biology areas that nephrology, deals in through hematology, at core of disciplined on fundamental build leverages both development therapeutic our neurology disorders. our XX, metabolic strength our business slide focuses internal research

programs. updates other Let our me brief provide on pipeline

PNH In and about, and addition the pediatric enroll studies atypical studies continue patients talked inhibitor, already patients to complement patients study adolescent we the and PNH in in HUS XXXX in treatment-naïve I've Phase with XXXX adult X in our atypical HUS. to

a concentration continue progress to also higher to make XXXX in delivered programs our develop of subcutaneously. We formulation

or now of in in multinational X fourth a we have spectrum single, this expect trial. neuromyelitis Soliris XXXX. from the placebo-controlled data Phase completed to quarter optica onto in PREVENT enrollment the Moving We study relapsing disorder, report NMOSD, study,

XXXX. on we results. and plans this waiting year. are an the to discuss close highlights team's study the the to the events look call With on for the final analyze the turn the As throughout study event-driven providing over and updates to I and to programs is for forward I'll our reminder, a commercial quarter R&D Brian Brian? that,

Brian Goff

XX, with potential with of the some first discuss PNH Starting the quarter franchise, business Thank color in with we patients and expansion I'll XXXX the on aHUS. you, our start complement grew including slide treated of our John. population of launch. the Soliris then and on XXXX, in-line

that greater we're for continue the initiate PNH to have of given aHUS, continue I'll in aHUS yet believe provide of more and This growing new Soliris bit We XXth our seeing still This patients opportunity as with on encouraging, that patients PNH. prepare to with treatment. XXXX is we the now patients our believe PNH that of In the is a moment. of especially identify to Soliris new launch. in with majority continued that we're and a strong still launch number year color PNH provides even starting on momentum and a of than efforts platform the a

patients track which on U.S., to Moving each the where launch, on very the become I'm XX, report March, of Soliris the REGAIN is population. slide of to trajectory there of end patients the the including gMG, with best were therapy. enrolled number the aligned XXX OneSource, on as see you generally are to patients month. patients study XXX treated These we're increasing in that in pleased

the are to As represent gMG, these a approximately with unresolved from total which inadequate to significant response appropriate antibody-positive X% immunosuppressive and continue disease reminder, had symptoms, AchR suffer to who therapy MG XX% patients population. of

with experience diagnosed. As in already we've the and are aHUS, and in discussed patients PNH past unlike gMG our

gMG. there the mediated destruction about of low in neuromuscular of awareness junction complement However, is the role

educating dedicated of complement in addition Our disease benefits in with the devastating this neurologists, Soliris. on team of actively and role the complement field specialized is specialists, and including neuromuscular

I'm Strensiq, revenue very slide metabolic has surpassed XXXX Turning that XX, first to the franchise pleased million. quarter with to report $XXX starting our on

Germany, and now us in with enabled following the U.S., new has also these funding in treating UK, patients agreements France, initial and HPP Israel completion to we're Japan identify Canada and execution in the the of patients Continued countries.

so expect to access have other geographic patients significant the can growth ahead. opportunities transformative countries We we see benefits expansion, in additional Strensiq, and of

that having expand Looking we population who familial LDL hypercholesterolemia, with levels. have at and higher elevated LAL-D, continue ALT and NAFLD patient at likelihood Kanuma, for an as target lab enriched testing to are those such NASH,

to addition, countries. serve we secure as we in funding expect In additional patients agreements more

leader our complement approved. in see of growth if Alexion XXXX, and believe We Turning that proven you inhibition. for can on the back slide ahead to record XX, complement Soliris a both has track is there global meaningful franchise being

We to the bar them by therapeutic raise which be delivered IV with patients as options, regulators, to eight for continue numerous patients life-changing could will the strive be for of of establish weeks new for PNH. provide and PNH. standard the approved with XXXX our strategy to first If care every XXXX

on that a we there shown to to of us slide believe number As position conversion rapid factors XX, well enable XXXX. are

a XXXX First, has profile. differentiated compelling

in experience the of years and PNH XX has patients. deep us needs of given understanding our Second, of disease the the a

During and these this time, we've patients. are with also the established treating physicians trust strong relationships who

experience identified if of into similar to Soliris launching patients PNH we a ongoing market launching in gMG, already XXXX our be and approved, will on treatment. Third, in who are

safety newly Fourth, as strong finally, rapid as treatment the to less creates XXXX. Fifth, from untreated well XXXX, as initiate schedule, physicians, frequent opportunity suggests the transfusion with diagnosed, for In is eight and well the addition, dosing, indicate current of profile And, over favor quality in the with compelling proposition its direct value physician XXXX. of XXXX trials levels and benefits feedback the the currently developing including PNH on options. breakthrough costs the as extension productivity interest coupled we're based studies, of enrollment low and hemolysis of and research initial impacts high both well relating and differentiated of patient as to profile efficacy and XXXX that dosing week into avoidance, the enrollment treatment every they indirect patients in profile, and a market for attributes a of on the patients life.

rapidly Ludwig? now of with for back all ability to XXXX together of So, on call deliver in I'll turn this standard new the the PNH. confidence us patients our becoming Ludwig. to gives care

Ludwig N. Hantson

Brian. you, Thank

very Let a growth that XXXX pleased over with with get foundation that the enabled long-term the We've strong us create position we a me and to very Alexion by our our objectives today's deliver us off This for start. conclude and to on saying future. I'm value. months quarter call performance established well have sustainable delivered great what past shareholder first to will to positions drive XX

their As dedication always, thank would to I like our mission. our employees for global to

questions. call now will Operator? We open the to

Operator

Thank you.

will of limit accommodate yourself question-and-answer turn possible, to In portion to please to as order We many people our as one now question. the call.

question comes first go Porges Leerink. from Our Geoffrey Please with ahead.

Geoffrey C. Porges

all ones. for the Thank the of couple quick question and you taking progress. for very A much

of that just And of in you markets Brazil? little if First, the parts of in may, and talk endpoints could certain world you is understand a about million, the then the to $XXX of $XXX if if from just from clarify close all going could bit from I in change the what's we to on we moving superiority million on were so trials. any what year-over-year perilously change revenue both a second question rest sort

contemplating Thanks. XXXX. you you the other profile in indications studies are have What either in or Now existing indications? the other for

Paul J. Clancy

Soliris your XXXX Thank of it's to perspective. $XXX that question because million probably the where question. I'll It start a the high. in as from unusually change of XXXX, the period some the timing ago. both quarter that we're on for out as of deferral part benefits geographic time clarify. first was that revenue well of One of first orders Geoff, And quarter was in year the a tender first comparing was actually the from is softness you with this points. Couple a sticks Paul. to is kind important

inconsistency side, America. had number a orders, the of quarter We're of lower Latin first we to in tender particularly going the of in orders. On XXXX, lot unusually flip an those on have tender

pleased you for also actually pleased, world. unusually with we When were high We're the particularly was incredibly the it an unusually low rest and think strip XXXX So time incredibly Soliris was period headwind. I one with apart, one the performance. of an

John J. Orloff

And, John. Geoff, this is

the I at Regarding two is remarkable. step were back your X successful, take totality the that a think, about you if I as data, of question superiority, studies and Phase look think,

testament dose that XXXX and interval from eight which the think regimen is All to took program think of through the two XX favoring Soliris, optimization weeks to better that versus from team's the a they dosing the I numerically fact careful going Phase reducing infusions despite and into the results that of provides coverage dosing a we're weeks X a to six. proposition. its be profile and the at we'll filings two on provides largest conducted and that's which PNH. pivotal in differentiated is to feel very this based we in and year those stands studies EU compelling data ever year of the and the this point, And been later Japan U.S. program this a value the own in middle on proceeding regulatory We

other with we study gMG to and also potential As year said proceed studies. later before, this plan a we

Ludwig N. Hantson

XXXX. we that I don't fast sure, a going will at with be label. reflected differentiated have we try look the that. the that And to think for the it, anybody conversion. to data best to trial be the The section. way a I need profile dispute for in claim we superiority don't have clinical successful we're And, We will believe get

a profile, strong, have robust package. differentiated clinical data We a

next be Brian of successful conversion. in experience we a in We'll we talking ingredients As have PNH. to have take about, I the the question. a fast was decade all feel

Operator

Company. next our with and Eric from take Cowen Schmidt question will We

Eric Schmidt

and very were be of helpful just you question two and potentially this compare there successful percentage majority a on us give conversion of or that some Thanks to time, Thanks congrats latest you on you're the Even Maybe, willing conversion and convert a components Could all three the your needed conversion for great to for seen. type comment if up on of all Would following amazingly majority? conversion having successful thinking Ludwig, what that out launch you hope on achieve XXXX. a give would benchmark we've other or years' to to conversions of? kind progress. the much. this patients within the

Ludwig N. Hantson

Yeah. Sure.

the this, thanks the and give we're about not detail. for more to little us bit So going forced Brian conversion. to But will question a talk think about a way

We as XXXX will on as market. have well the both Soliris

ingredients non-forced I all is to successful said, best-in-class within be about conversion As that. to have is the Brian and of talk to to going our we be a be and objective segment best-in-class

Brian Goff

Eric. It's Hi, Brian. Yeah.

building that that, on we have very feel We noted, as studies after. and we had that results. Just the now two we profile distinct commercially that's we were that Ludwig have consistent have what And wanted. complementary

with plans, formalizing it's for it's to ambition think There's But all the is prelaunch good and care comments, his market think to commercialization And no physicians on years proxy perfect path the how in fair make XXXX the to achieve, known I as noted that. have as XX-plus as a at that. patient my back we're profile is. go prepared we've in a well kind to don't differentiated anchor commercialization with we able primary with we of really were that of the so, well-positioned fact the new done what PNH. and enrollment that's standard which identification, have research in payers I through and And population we as looking we stage as where think we intensifying of PNH, team John at this for really the experience want for Soliris that analog we're with

Eric Schmidt

to up estimate? where to more about a If with able a up, was formulation time. couple saw XX% get I recently can years' the conversion a conversion COPAXONE, follow convenient within we non-forced reasonable share just Is that

Ludwig N. Hantson

become is bit than indication. short might objective a in within a conversion of be situation the for PNH here. But little our that different the with the market think I time the COPAXONE leader XXXX period we're to

Eric Schmidt

you. Thank

Operator

from ahead. now question with We'll next Raymond go Jaffray. our Please take Chris Piper

Christopher J. Raymond

Thanks.

all on at market given therefore playing The could sort length about talk really you et of just brackets is with there than team guess this patients how around market get more defense, its could to compliance, I prior utilization in is the done, question drug, be, to XXXX, maybe is expander. what research used here cetera? and XXXX. terms another expansion Just the the guess work a increasing put chance increase management question drug, that is I could wouldn't some at any normally that of profile least actually serve you've

Brian Goff

but Yeah. question. in we term, It's reason brackets, on fully not – waited on who yet we are tough treatment identified or And a you may burden that the some better the for Hi, that have not again. to optimal precision about identified they of patients the are just another, a It's sidelines as Brian treatment if which U.S., on them. good aware lack the but of there of talk Chris. for and, is are put for say, it's be one are

And up example. that's And as think indication. PNH be as we we the build opportunity future so true as with could same in an aHUS a

PNH with the the well you XXXX untreated a some talked conversion patients given but opportunity So, as so the really fold, known those a just currently growth offers. we've as is that noted, profile there it as do on that come to about of with rapid population, into focused expect is patient we speak,

Ludwig N. Hantson

Yeah.

also later on option MG. subcu with a embarked you a know, aHUS. here. a as with will conversion a there, start program we a PNH. just play will a about MG. still XXXX, We lot it's We the also have says, year but conversion MG. Brian will growth talked critical opportunity it's start strategy As also of In this strategy, role that strategy The for launch We also

the a Some the weeks we every patients other then likely will indications. prefer an subcu that most like some prefer eight patients see infusion, and potential infusion. They but

it's conversion think Brian's growth strategy but a message a is also and strategy. I So message it's my

Christopher J. Raymond

Thank you.

Operator

on Harrison Morgan question next we'll with Stanley. our And from go to Matthew

Matthew K. Harrison

can I Good questions. the Thanks guess for Great. morning. updates. taking if ask two I just

about good other I now on about about nice thinking that So XX% we to you one, update you looks that right Do second, patents of like can just conversion then with the heading gMG, translated and what the us sort in of tracking the come revenue? And help XXXX terms in on into mean, And also, it us out future? in gave of the what's happening rate you at think patient OneSource for there? any feel terms side. and you're numbers how should patients situation European of some that

Ludwig N. Hantson

take situation I'll IP in So Europe. the

everybody So formulation patents last got just patent. that of new were in so I'll composition understands that as of make back patent, the sure the take we've issued U.S., three to year a as step that matter well use manner

the call. know that since are feel has a just the respect covering With good the also Japan the approach applications QX Japan. and We the did I discussed. the very nothing update do You'll in last in patent three pending. of to topics we similar changed U.S. we've XXXX that strength about new using as Europe, in a on got We're

for there the back reminder a a way As that innovator is EU and everybody, the the in is forth different patent office. between process and

inventors And so offices patent the to with patents commonly prior the having in discussing engage allowed. rounds multiple

call. And report our that's since MG? So last point important respect new earnings at to this then with understand. nothing to But to

Brian Goff

feel good we with launches which best Soliris MG. MG, Matthew. of we're seeing, excellent to particularly pleased I this morning, our respect say Brian. of on I'm noted, we're in really really patient the track with to uptake to times, pretty the gave U.S., that specific in and Good happy the terms the numbers And about. Yeah. we It's several uptake. With We are make as

as note neuromuscular are specialists is is the not really QX, prescribing, in clinical well that tracking. terms of probably which well that the both important note patients, is So REGAIN trial U.S., of investigators. the And your they're quarter neurologists, models are can how precisely in not to the that patients the as first update terms and full for the we're of of you fairly launch as what I'll in majority

sides too open So one the we're seeing. the terms cases of And as question the it's in about that OneSource treatment, uptake elements we early to open With well patients through refine long to is, it as patients is that tracking Soliris pleased equation of say feel is the to are move behind real both treatment. the it what exactly on What to cases respect good about much easier so-called continue through move as is well. throughput treatment treatment, I the enrollment, with your in we're give quite just to we're on how as through. for takes model that pipeline of progress strong, OneSource patients throughput also prescribing make breadth of of continued to precision will the of and how learning to to

Ludwig N. Hantson

expiry issued good we And is Japan. patents, Europe, XXXX. the with matter on U.S., picture our to XXXX with are and composition respect have IP these in just patent of and so question, the about complete situation to The XXXX, to add patents feel the we

Operator

next now move to We question. will on our

Ludwig N. Hantson

Next question, please.

Operator

with We'll take next you. question Anupam from Thank Rama our JPMorgan.

Anupam Rama

me seeing therapy ago in of there Hey, so worth so Are Thank patient on Strensiq market much of XX from you're question. trends the XX or guys. therapy much. worth months noting taking to subtypes that and noting? you relative any dynamics quick there. initiation HPP initiating Thanks one on any Maybe trends for a age are to that

Brian Goff

seen continues With in area on of I Yeah. and I'll working call to because Good metabolics morning, opportunity team the to Anupam. stamina, to a patients. about the identification who disproportionate of that It's is proud you've would is say respect equation to are have really the track the These have, of Strensiq, strong I'm Brian. take growth is Strensiq. lot folks it, Strensiq the well. on

efficient. that some who country importantly, they're making to right exactly improved that who testing we to again, a but in the growth are in have the potential the sometimes what terms continued continue. most behind becoming in to, to genetic journey doctors convinced funding really the of more sure have as identification of that see trend expect benefit the their that over it Strensiq therapy will from becoming course, could they to is we benefit growing efficiency then, that who And patients those access of need is due global part adopting. – transformative And there in folks, Strensiq And, HPV to could and U.S. clinicians access. and to of difficult ex-U.S., get around the of that it's the And then, And translate of patients. to know finding find specialty their go They're with driver.

Ludwig N. Hantson

Next question.

Anupam Rama

taking our for questions. Thanks

Operator

question Thank you. We'll now Terence Flynn take from Goldman next our with Sachs.

Terence Flynn

the questions. was given the might any Maybe two to change Phase changes seen then Paul just getting comment based rate if Can Hi. you the what's you that two prior wondering maybe on sustainable make that the for you in and what tax guys on Thanks one quarter. just think I then, XXXX for on can from you've data trials. And you that's taking Thanks. comment there underway, gating that me. for the program, drove subcu on if X what the just and longer-term?

John J. Orloff

Terence, this is John.

on is subcu program So track.

be performance planning a drug trial discussed, formulation the testing, study in initiating single quarter. As what's bridging previously to we've That We're doing also PK-based initiate testing. device factor and we'll to quarter. human fourth fourth and IV in us to is testing, the compatibility gaining that the

XXXX. to potentially of also volunteers And a subcu QX-week half us QX-week, will be in on the that's get that in second in working we're delivery. the a that Halozyme next-generation have healthy formulation formulation We together with clinic also track

Paul J. Clancy

thanks on tax the rate. question Terence, for

what conversations way points into to some tax U.S. towards on coming tax you I had this of the had would've the about thought landed So as it year it discrete reform, think now reform. upward year about what's impact is if tracking from of the because that. kind best not we points lower or recall had we benefits, U.S. where basis we last the we that think end around basis – We're excluding XXX pressure, had but we XXX probably from

points into we probably I but XXXX. think bit go closer so be pressure, there a XXXX and little might And upward basis a of as to XXX

that's tax reform to interpretations everyone's the but current of evolve, So, interpreting change our and U.S. obviously, that's as subject thinking.

Ludwig N. Hantson

question. Next

Operator

now We'll with Schimmer ISI. from Josh Evercore hear

Josh Schimmer

taking question. for Thanks the

As to we gravis in disease from pathogenesis labels? on Or have the one doses Soliris? full versus myasthenia Thanks. non-inferiority used for apply others, disease trials that? to any for biosimilar PNH Do consider label you views this extrapolation does aHUS separate would separate necessitate the and

John J. Orloff

what's biosimilar of the think, this stab that. indications, and with have to to with mean, is may sensitive comment some most the actually us a It studies. the So for And other come product is we the clinical extrapolation required disease. is And the on not population exactly been require now what development take I In circumstances for Soliris conducting would case, allowing additional to the it's, the always on and studies in I'll dependent, John. for market this to program XXXX. that and I data at really I but case. premature typically, think, given be

Operator

we'll you. question... now on to next our move Thank And

Ludwig N. Hantson

question. Next

Operator

...from Geoff Meacham with Barclays.

Geoffrey Meacham

a for Hey, lot the guys. question. Thanks

Just had a couple.

more Soliris as read dose reasons front, at look Wilson level, a platform deals? a bolt-on super that you. the few second gene Thank raise a And is pipeline, expands how for you say, the high deals obviously become wanted if more have, with towards to a more let's refractory the If the tech bias patients why the therapy, a question capacity or near-term of you or change what's longer-term impact on which a therapy X product-based the BD the to there's data And what discontinue to platform? deal XXXX clinically? could versus cell into have Phase the but I see to can like that

John J. Orloff

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

PK-based think have better share thing in I in as levels, with PK/PD from to more highlight the reduction what our Phase Soliris. our year to this of And program X that of breakthrough the XXXX seeing that XXXX, hemolysis. we'll data interval with getting unlike of suggest is we analysis later free some any cover seen sustained, patients have and we're one continuous is less dosing effects, breakthrough in terms with CX way not a we're the and

would an there titrated be have is that Soliris. think I'm sorry, patients we XXXX otherwise that with so with And there to to opportunity up cover –

Paul J. Clancy

Paul. is this Geoff,

that. you I one on bias. was of parts think kind two capacity, One our had was

frame it on in cash. talked I up capacity, we I'd as prepared we of So billion $X.X think, about the have remarks

for We half expect to of the Wilson use than that a transaction. bit more

all out, some we've year laid financial part parcel that's flexibility. the that throughout and to and We ambitions strategic have cash generation create the

at We undrawn an point. also levels about $XXX this our of to debt-to-EBITDA access manageable And million. have revolver are

that So I pipeline. but development. rebuild opportunity bear potential towards our represents inside is against you've characterize example say disciplined that diseases, pretty still believe hard, rich. we the I is got is of we're towards devastating priority business this would disease, a transform Never to pretty good have that no ability Wilson our rare disease, capabilities doubt about do the bias never, it, strategic mean, look capital company. think building the the Rare but not set to allocation and the our set disease. and a it's to to opportunity to I We platforms. – product products, up bias. the firmly

Geoffrey Meacham

Thanks.

Ludwig N. Hantson

Next question?

Operator

Thank you. with now question We'll Citi. take our Robyn Karnauskas from next

Robyn Karnauskas

my congratulations taking for Thanks question and on strong guys. the Hi, launch.

a So I couple questions. guess

go doctors? just question it time to patients? I'm have on Or the you seen how you a takes was doctors seeing What So on just because the you'd is a I the spoken amount these get patients physicians. time takes from thought of have uptake concentrated for breadth are these but kind a couple go second MG more it is drug the In you are they always injected before to it then this given thinking are patients mentioned out amongst treating months about maybe patient with on the perspective. you've at patient vaccine. get amongst, about spread Soliris? MG of been can that And to have OneSource, that. that clarify how of they minimal the

Brian Goff

respect for to like month Robyn. one, as noted, get launch we're area seeing has a with around the It's for determination. With still commercial for side. all we treated the the we're I quarter getting time we're reporting an in open Thanks and Soliris, out of obviously for is it's U.S. because were what – as full puts the vaccination actually the question. gMG takes to sync been with to now who from on funding in process challenges of OneSource, general morning, lot are being it and And verification lot Good therapy. a their patients then evolving the if Brian. and that getting a I first the our the generally first coverage they patient our about is sort But One use in on go case with to identification to have onto the as we've progress of way the made there's where vaccination well of feel on a depending averages, that

in are commercial than of plans defined the with and policies line are largely more REGAIN Now XX% or criteria. than those better the

So process. general to we're that that terms, helps, what But in speed in regard, of seeing. that's, some And then...

Ludwig N. Hantson

would Brian, the scenario... month one best-case for be

Brian Goff

community part it, that you to, of initial And was been that's therapy. what some of queue of general the longer most coordination infusion headed respect the those itself, and is for as the sort is an next, clinicians, we're example. open the and where as for seeing that specialists. are few Yes. where across the are is to taking that's there be puts hundred neurologists of still it a in U.S. comments that on from They that, be prepared takes back-end tend days. coming cases where are there yet And and patients a and in the we can not I and my who in concentrated And patients neuromuscular we're the target to treatment do is have centers though the you range of still most prescriptions spread it's with again, also in of in called early the who And of converted saw

than just concentrated more neurologist. somewhat any is it community So

Robyn Karnauskas

opted other – can that centers, not of And you're element I then question up another therapy? that the of drug? into just of who someone us then concentrated hitting really as see you areas get with expect out OneSource and question? sort into have because to year to not in some a should to therapy could that you on most there broader this is someone one of can all slowing? it we expect opting slow Would follow or And time So the we element more you go is example to people went get give then was

Brian Goff

have now in we has done on somebody also not case, then time. that they've out like got opted become Yeah, feet, they've went and where is in, they've And therapy. they cases cold cases sure. maybe back We've opted opted had decided that, and where right had a the

kind haven't pleased ambition, off, plan. launch of from So we patients with definitely continued respect still equation is about point will some with very more and it of towards severe a continue out days or question slowing the our With much of these early earlier seen we at of your it on in the progress. a uptake. we're really yet We do move the side the therapy. expect our leveling to that option That's that to

Ludwig N. Hantson

add just broader structure investment prescriber that, and just academic will than But that base reflect prescribers. broader we it's have, to to centers. our since community-based It's the also

XX,XXX to we way long XX,XXX a go we taking have a where are We from refractory to X,XXX. X,XXX MG now, about XXX, to talked to

we So have way go. long still a to

numbers that are down going expect don't to we slow soon. So our

Robyn Karnauskas

for Thanks my taking questions.

Brian Goff

Sure.

Operator

Bank Thank you. Lynch. Ying with We'll take our of from next Huang America question Merrill

Ying Huang

geographies for plan give for timeline bit not? have Soliris? hoping for Brazil resolution potentially to a non-responders trial or what's to What's the in you a Thanks you of clarity and question. do us can Alexion start specific on that? next patent the little this any And Secondly, was Maybe Hi. situation. other could to I spread the XXXX

Ludwig N. Hantson

incorrect. that respect the to media With saw Yeah. were Brazil, we last so reports week

short usual. I business answer the situation us, is for Brazil in as think is the

was does Court message is to is XX Brazil and And This how ex-Brazil This of on impact happened years But only. of on XX not think Superior reaffirmed usual. term any countries. from determination mailbox patents prior no, versus I Justice the calculate years as business their so what the the new, have filing from nothing issuing.

Brazil of know, revenue. our you As is about total X%

yeah, they're the patents, is and respond to on options looking way no is back they that's pushing We're what to I doing And have company to at message business say to the so what one, dispute. and impact what only But we're the we're not week. we're as our last we ex-Brazil. think ongoing on listening is, exploring the usual. an This saw only

John J. Orloff

by studied Then, a another. Ying, program and XXX that additional conducted in studies, just in XXX reminder that clinical largest covers We to to-date the study ground with regard PNH again, one patients. PNH in clinical is the population about with the far this broad really patient patients for

naïve have We patients.

have We patients. Soliris-experienced

we've are patients and and Soliris. analyses for studies who favorability independent. XXXX that both have transfusion conducted versus subgroup We And show consistent effect for dependent

to So Soliris. Naïve with And considered regard to your evidence comers, presumably breakthrough. no very study there there of results as a question, that would with the enrolled favorable PK-based we I patients all and might had said, in be there be non-responders

that confident weeks of provide So interval dosing to out regimen we're with benefit infusions to cover from that right and to the dosing per the got dose we've six going eight XX very and extended patients year.

Ying Huang

Thank you.

Ludwig N. Hantson

questions. We'll take Okay. two more

Operator

up for Hey, research LLC Securities Thanks of versus on on a the next on Credit and clinical market patients just Suisse. We'll (USA) a with to you. Martin question Suisse conducted appeal docs. guys. for the Thank you've question. Martin XXXX internal - some the our Auster from follow Auster relative comment earlier made take and IV the taking subcu Credit about wanted I

for could certain subcu add that aware on were of if Just if certain IV have there's there's kind Thanks. curious if towards views you color if that – or subcu? different more on geographies you preference skew more versus indications there's

Brian Goff

from and the about studies other is is related general, a the we That that profile we wanted where that transfusion thing appealing. think it some prelaunch the that kind to overall far, would pleased six. has just as formulation. in not for to six XXXX, out is about is the that And, two have patients benefits has we're elements. the that that like what clinicians, it's some those be to viewed research planning prepare finding XX focus the been we totality It a breakthrough our is in infusions so to these other consistently to that XXXX to of to Martin, hemolysis And of our of positioning The described. numerically knew start of quite we infusions. IV data quite moving it really exploring are avoidance, for see consider what moving What really played as profile commercialization. from convenience Most year and offers impressive in John different about with begin in XX particular, we benefits of important things well now

Ludwig N. Hantson

talk the course, now we months to to you Phase up is have the from launch. market but As to insights be we make get, and that I we going profile more research. on over X for there's we the final think quarters to come, successful And studies, as everything will this us of the continue a update lined additional

So we'll more take one question.

Operator

We'll from with MacKay Kennen RBC question take you. Capital Thank our last Markets.

Slanix Alex

the Slanix is level color rationale you. wanted the the Phase on This if designing just morning. and for some aim just additional as wondering for the well X the of Thank Phase as to superiority. the trial. was confidence on I question. in I X Phase Alex Good for to and X briefly could provide Wilson results Hi. on Congrats thanks touch taking Kennen. on quarter you

John J. Orloff

Yeah.

So which something evaluate a program the opportunity a we Wilson the for Yeah. to reduce thank had Wilson chance affinity ability which It's in at the now, to currently WTXXXX, will order due and enrolling. and deal. of designed disease the be X look with Phase we'll the neurological going program, take is deliver, you. really is patients that risk for for the through profile differentiated optimize be XX,XXX-fold worsening closed we're Right de-copper, carefully provide in transformative to copper, John. and therapy convinced the greater Wilson And to development We've underlying a patients. a obviously to diligence addresses symptoms, a haven't

about come chance and we've the might we had investigators, currently as to well more as consummate deal the development or it alter program how as to talk on So, to a that regulators enhance exists. after

Ludwig N. Hantson

Okay.

end So call. that's the of the

We're really, pleased quarter dialing want So all with of our you so for I dialog. thank and first to really continue in. we'll our

So thanks, everybody.

Operator

your today's conference. Thank participation. Thank for you. conclude you That does all

may disconnect. You now

Alexion Pharmaceuticals (ALXN) 26 Apr 182018 Q1 Earnings call transcript