ALXN - Earnings call transcript Q2 2020 | Alexion Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Alexion Pharmaceuticals’ Second Quarter 2020 Conference Call. At this time, all participant lines are in a listen-only telephone. Please be advised that today's conference maybe recorded. [Operator instructions] I would like to hand the conference over to your speaker today Mr. Chris Stevo, Head of Investor Relations. begin. may you Sir,

Christopher Stevo

Good to you the discuss of operator. on second joining today’s XXXX. call Alexion’s morning. you, for Thank us quarter Thank performance for

Goff, and we we Chief Today’s home. Financial Chief Sarin, Global our will be our Hantson, Orloff, practicing last be as Ludwig will doing Global quarter, Officer; Operations by R&D; CEO. Just physical call John did call and distancing and Head our our are led from joined each the Aradhana Brian are Commercial of Officer. Ludwig by

call We will time the begin we and will questions. your the the the with of brief presentation, rest reserve for

You and of our on Investor that slides other Relations our this website. earnings can material to the call Section on by webcast Event will page be access going presented the

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

Ludwig Hantson

to and them. systems pleased rare We performance. impacted everyone. supporting months committed And around the care world. families Thank disease last several and you, tested morning, share have has worldwide The quarter individuals our to remain the community and health Chris. greatly been I'm good know the second community, global

through a strong Our the at time the successfully we move result plan challenging of This us this of we is contingency execution will as navigate ability beginning against the pandemic. forward. to guide developed

to transforming Our for employees would overall continued I our rare strength and the the resilience thank work like the devastating demonstrate of their of business worldwide the of people and lives of your our to mission relentless commitment with hard performance and organization. conditions. diseases

delivered XX%, and progress performance Turning the very second non-GAAP with made we financial have to the year-over-year. XX% in we EPS another quarter, revenue growth have strong growth

momentum to the of we entered As financial a business. increased demonstrated execution, full-year and growth by a our result, guidance for reflect continued stage have the financial flexibility. diversified company, growing and one we pipeline, have the of new excellence Driven commercial we a

and to corporate we business growth the of strategies, the areas compelling value development most of allocation this actively landscape review part to evolution, support capital plan industry, for long-term As we creation. opportunities ensure our potential assess highest

we more a return pipeline three the make more to multiyear to in last all a confidence how are shareholders. progress commit ability As the but to continued flexible now capital, have result years, we to able deploy the company's a over we be and of future value in

annually free through minimum committing of have one-third to of flow from a We least the share years, to XXXX. our in XXXX million over average And few cash flow and cash free at significantly $XXX $XXX are million of increased repurchase XXXX. last an

about We opportunistic commitments. will the this also continue to

focus. of value for we may last primary recall, laid creation out a strategy you multiyear with year, areas As three

around first complement. leadership The in revolves our

We goal We on-track our XX% and conversion ambition for in The just PNH, getting approval XX% in the area two ULTOMIRIS the with and German U.S. conversion leader by establishing ULTOMIRIS our is within month's HUS preparing Japanese have in October more U.S. Commission for is in years. market than are to SOLIRIS last launch in achieved last lunched European year. our initial team this as HUS of started achieve this later decision, for the following

data addition, for patient's formulation, will additional continue choice treatment treatment once-weekly received subcutaneous Phase III we improve advance efforts experience. to which provide our our to In an We positive ULTOMIRIS for patients. non-inferiority

began franchise Next, in into We this new therapeutic and the expansion we CX which expanded broadening into already neurology, U.S. franchise with area. has grown are a largest a

to continue U.S. to neurology on-track patients number quadruple are this of on XXXX. by We the build treated momentum and

Phase GMG, all studies III in ALS, later and plan underway, stage to in this we additional addition, NMOSD, In begin several indications year. ULTOMIRIS and trials new late

forward we month, and have Portola we very the welcome portfolio developed. we new into development this colleagues Third, to significantly of commercial diversified business acquisition our our Earlier and and to excited the great are a developing we completed discipline transformative stage look for the foundation strong strides have together. made organization. built We Collectively, therapies and of advancing future. our shared mission to have advancing transforming Alexion

by end launches XXXX, for Our potential includes development pipeline from XX XX the with four programs up now XXXX. of at the

double-digit to value to foundation well continue continue positioned a create are ambition on to we we We value. shareholder result ahead growth. the execute lies have of on a strong our established, as strategy believe also revenue As of delivering we significant

thus progress foundation a substantial and upon strong created made which have to continue have we can We far deliver.

value turn With over focused Aradhana. Importantly, Aradhana. on shareholders. to will call long-term our our for now as continues, that, I remained journey we driving

Aradhana Sarin

Slide Starting XX% approximately increase of year-over-year. reported billion nine. Ludwig. total with X.X revenues second an of you, We quarter Thank

franchise We line are driven EPS XX%. pleased XX% $X.XX growth. trend businesses, of year-over-year, Operating the non-GAAP by core in volume our the growth representing and top metabolic and we Non-GAAP margins was with which growth business. the strength growth atypical with quarter, saw into over onto the strong by PNH driven neurology QX, margin momentum continued in operating primarily our was in HUS

Moving to Slide XX.

was each Second markets. ULTOMIRIS growth second million, atypical primarily year-over-year sales from million, contribution SOLIRIS conversions ongoing in XXX was our product growth and in revenue PNH, SOLIRIS offset quarter neurology Starting quarter launches in flat approximately HUS. the and volume including XXX indications ULTOMIRIS of XX, medicines across to second to by in revenues SOLIRIS and was was by Slide total key revenue HUS. net in are the quarter driven the atypical

decision cost costs million and to for per SOLIRIS a Total represents X.X compared maintenance XX% reminder, lower franchise annual prior XX% As the revenue made to phase In PNH respectively. and of atypical XX% a patients patients quarter annual SOLIRIS. ULTOMIRIS, lower by we the revenues HUS to strategic compared year-over-year. on second Metabolic for ULTOMIRIS driven year the were volume. versus was increase XXX patient CX billion the growth XX% representing for an

On the well. right the historical highlight not revenues Portola, of in by ANDEXXA Alexion slide, as as reported are we included which

Second not quarter related adversely demand been to policies sales, estimated conformed were accounting Alexion's impacted productions. has which ANDEXXA by COVID

The quarter year-over-year. on revenues. in was or XXX R&D XX%. or Turning Slide was expense EPS Non-GAAP SG&A was approximately during of Non-GAAP GAAP second rate quarter growing of the the non XX, million non-GAAP expense XXX revenues. XX% XX% million XX% quarter to the tax of effective P&L $X.XX

based new the second billion. quarter, patient view of revised impairment long-term and expanding commercial of reduced challenges growth on in projections opportunities. KANUMA two its strategic alternatives KANUMA intangible This cash and spontaneous the assets company flow an During resulted of approximately

securities We of per result billion of a was GAAP earning $X.XX. the repurchase loss and million As share cost ended XXXX. in X.X a during with marketable shares X.X XXX approximately cash million of approximately half a second quarter the first at in

an to would our XXXX XX, like to Slide to full-year update moving provide Now I guidance.

closed past continue learnt Portola lot and acquisition COVID-XX As early in the navigate we global we the we July, pandemic. few mentioned, through the months a over to of have as

As around reopening a we the our the with top-lines, through Starting are evolved billion would healthcare reminder, over globe we that to XXXX. you systems has X.XXX full-year walk X.X July. increasing growth where we gradual to reflect I XX% with guidance our the the billion quarter guidance for in assumption in midpoints the the first guidance revenue our to since to lowered time. a how start see will that

and product In guidance XXXX is updated of terms SOLIRIS million for ULTOMIRIS to revenue, XXXX million.

to guidance million a business XXX XXX While is million. now for metabolic

We ANDEXXA for second. XX XX expect million to also of of revenues half million the XXXX second

that showed compliance all remain quarter level Second to of COVID indications. pre our across rates similar

the in of light We see of advantages regimen. eight the strong also week every dosing ULTOMIRIS continue conversion to

and continued margin the starts, non-GAAP potential queue initial is mix, of to and to the of the to Portola to and sales expect us achieve million and and as expected underlying over to acquisition. case least prior Despite relating care access for second and Portola aligned ANDEXXA of globe, from fair growth compliance over strength close quarter the and expected and $X.XX reflects expected $XX.XX year, historical improved SG&A estimated revenues, following transaction. we is and increase Non-GAAP XX% XXX continue The to million patients be the of GAAP slightly XXXX We reflect fact operating expected following dilution term, between be unemployment $XX.XX. includes investments guidance. to allows impact the still These short-term that margins. the to business Longer is Non-GAAP XX% between of and an be is expected fluctuating to given be between approximately be rates with margins prior a Portola monitor $X.XX, spend expense wave. EPS investments GAAP both between U.S medical of EPS addition performance about XX% guidance. our XXX XX.X% XX.X% at Alexion the absorb midpoint above our rates XX% EPS across to is Non-GAAP of indications, the of around new profitability to peak bets-in-class is OpEx dilutive, a the revenues Portola. COVID non ANDEXXA the just R&D remainder of to be $X.XX.

Since improvements this Ludwig have free earlier both in significantly flow. are the cash with allocation our XXXX, grown As top-line capital we mentioned we robust morning, business and our updating strategy.

assets. significant transforming one that programs We now just XX to stage XX handful CX in across programs in investments portfolio, have made XXXX our of it a R&D clinical includes from

pipeline existing and to patients As our highlights to continue alike. in drive we invest move we shareholders for value commitment. our long-term updated Slide forward, XX, will

allocation that just our mentioned, a allows balanced to XXX as and result of progress announcing time, XXX the I capital more At in are least to Even intention us this shift repurchase at pipeline confidence million shares we to a XXXX. our strategy to that approach.

this to average annually a on increase We flows, cash XXXX free of minimum from our to will of one-third XXXX.

We will repurchases amount, as additional this above markets evolves. and consider business landscape the opportunistically development

further are we this the near-term, on the in October integrating of effort activities. XXXX. billion call end, strategy update addition The support approved creating powerful X.X in in R&D focused over remains repurchase shareholder on BD maximize Board Portola provide the authorization the from to shares, value. now authorization of billion to To and approved our turn this I a transaction. disciplined While value John will an to in has to one

John Orloff

you, Aradhana. our has on EU. in In approval it evolution programs, XXXX, have can HUS posed Slide quarter, the current the a advancing portfolio, we see COVID-XX. in you Thank ULTOMIRIS the by development progress XX, for in challenges in we our clinical significant today. This atypical resulting significant received undergone stage Starting year, pipeline since robust despite the made and

PNH from third provides Importantly, quarter data we in opportunity device after ULTOMIRIS first and be their has are positive weekly our data XX-months top-line the the choice and for self administer results trial the treatment safety atypical XXXX, who and combination to for once an drug also of to both treatment patients the file subcutaneous on-track HUS to reported are and collected. subcutaneous It medicine. additional option prefer

we as and the closed ULTOMIRIS urgent been ANDEXXA steps we earlier program, busy assessing this integrating expansion as transaction into have R&D Alexion, for also are certain surgery month, the including d well activities Portola’s lab. next geographic Following label for opportunities

have a made progress our of and dedication the this moment is built to Turning the programs R&D. to our real of we in the data, approaches world current embedded site accelerate spite like study startup would we to to in to of leveraging a within I testament efficiency. innovative Slide capabilities we inform some enrollment operations. strategies on quarter pipeline maximize In The and take XX. to environment have highlight to innovative clinical designs, order focused our have the teams

at even services, bodies. built some we cases this home. the bring safety maintain with program at allowing us the An We is to have robust on-track. footprint monitoring have capabilities home also ULTOMIRIS while trial effectively implemented to our and across keeping patients example to infusion the our patient trial, local liaise the And in regulatory of where GMG of

have better the enhanced clinical to machine analyze capabilities addition, artificial and risk In decision making. learning these trials, XX to ambition the organization. built XXXX. data-driven innovations we bring increases advantage allocate of for launches support us to overall by support capacity and the digital our leveraging and remain on-track enhancements productivity we These our allows enable that resources Taking intelligence of and

of Turning mentioned weekly Slide launching Starting the have potential subcutaneous year. the programs on-track earlier we by current the that the and see here potentially XX, left to opportunity we filing for third highlight XXXX quarter on once presents. program in as next I we ULTOMIRIS the

neurology the our present opportunity PNH nephrology GMG atypical to share greater population ULTOMIRIS by HUS patient ULTOMIRIS NMOSD treated XX% expanding enrollment also with of greater beyond and patients. XX% thousands I’m enrollment. our which programs, and achieved are that well has than collectively businesses trial expand than tens our of CX pleased achieved and has portfolio We to an

just program enroll. this year initiated ALS to continues Our

I to where Guillain-Barré and a our Compliment next syndrome. we highlight opportunity is Solaris early Media-TMA year respectively. this study our trials to have within initiate addition, The remain and pipeline in later Japan, with study, also GBS. planned on-track new like In in granted addition been in improved this may year HSCT-TMA long-term the designation that from treatment IVIG to MHLW by in sponsored have investigator medicines Results few the with one standard outcomes care Solaris, suggest of of to received an SAKIGAKE patients for result distinction. foreign would

the in Alexion opportunity partners business into at with year. additional II, we our scope. to this Building forward four Amyloidosis And II to half with The this late-stage program Given has will XXXX. currently pivotal in program Phase beyond these the diversify Phase later successfully investigators, assets results completed. portion our taking AL Phase recently dose of III and forward be and see Phase look this with program the on close a the partnership III of ranging we CAEL-XXX Caelum III working with novel to initiate first CX foundation,

in plan first As we enrollment previously Phase ALXNXXXX complete disease III for III Superiority Wilson of shared Trial continue half had Phase our is for in we data to and the care of be daily transformative action, next year. a XXXX has the disease and convenience Wilson potential with to clearance profound onset its of oral new copper rapid standard in once dosing.

on-track AGXX later ATTR remain ALXNXXXX therapy begin and Finally, trials both Cardiomyopathy our PNH add-on year. III programs this Phase to

significantly is While to we patients support capabilities robust there pipeline ambition that always to clinical confident we development, our innovative will and risk R&D expand of serve. our are number in

level PK/PD the earlier alternative addition, update if patients. of Turning did like the support disease results Upon XX, in provided the an on data, CXG, to of Slide significantly control would in and but some our and programs. to of review proof I stage a of provide not ALXNXXXX Phase clinical mechanism II recent pathway

the indication no along While did as for decision the with to other support a subset a signals made proteinuria, show patients we reductions Factor target. of rationale pursue with the longer that ALXNXXXX, D in have

we the next with Factor D indication acquired of So, and in from The are Achillion. program ALXNXXXX. including renal inhibitor such a exploring as CXG, generation next steps consideration

and suited inhibition, alternative greater for life half pathway longer XXXX’s, the will be it better Given levels of CXG.

indications. lay of On the strategy out right, in proof we concept our renal

Basket proof move into strategy A As be identify us nimble indications to efficiently Phase with previously appropriate of most in concept will announced, will both development. ULTOMIRIS III forward trials we to initiating the allow XXXX.

we and the patient the indication, twice the In of and route balancing consider of daily IV convenience will needs, XXXX. the administration considering and efficacy addition eight the week advantages every ULTOMIRIS of both dosing infusion asset to with oral

indications the ULTOMIRIS half this a is the of Basket of second planned study of indications sampling begin in to under identified final of Lupus to as year IgA half and first Renal and of Membranous is start we The in Nephritis, XXXX. study Primary XXXX CXG While Nephropathy the have Nephropathy, interest. list evaluation, still

Finally, this at we due ALXNXXXX, quarter program to unable volunteer to were FcRn of the an we we bottom last on healthy slide, as continue update have our of studies program. Recall the left in COVID-XX. parted

half the be will reinitiating in We program XXXX. the of first

FcRn, are landscape entirely evolving the Given and for autoimmune in we myasthenia hemolytic to our shifting gravis. administration an approach route of both subcutaneous form anemia generalized

data milligrams infusion potential. subcutaneous our should with the pause a dose did meaningful IDG internal to our we highlights turn has XXXX differentiated single ascending multiple we of modeling showed program. over on-body single commercial believe doses than Brian. FcRn. well Coupled lowering. the subcutaneous were have from weekly lowering While suggests a Early to will tolerated had to Further, device, XXXX I be and and convenient to provide potential that, greater XX% Brian provide quarter. IGD a With a call

Brian Goff

John. you, Thank

Turning first care in I goal. months to to set That capabilities. one target an that and there is team’s to execution Germany new proud ULTOMIRIS of within of for share year speaks meaningfulness launch. nearly that ULTOMIRIS incredible and a over of first patients care our couldn't in have the the ambition its did conversion and At launched accomplishment when conversion I of just U.S. in standard we past reached excellent launch since is the also in a to has as would ahead so less we XX. of within we year like through this the a than PNH. XX% since And our initial the XX-months, Japan six XX% establish initial established for two to over best-in-class time, of ambitious by XX-months years. back reflecting start be standard an ULTOMIRIS Slide U.S. XX% we that Today, achieved patients more

continues journey achieve ULTOMIRIS atypical two in on-track similar we half received as HUS of late great We of XX% approval news EMA ambition conversion atypical year. this expect we Japanese for of within Our second in HUS. for to the a approval And years remain a June.

the remains strength current their we committed ULTOMIRIS this to the serve on-track to the the to half bring launch leadership Beyond of and and improve will patients, formulation hours approval opportunity about being this concentration This XX higher approved continue value of to reduce for which overall. from for when remain excited minutes. In experience year. to innovate of our diseases the we proposition, patients in infusion we are the time second ULTOMIRIS and to two

forward look the a physicians also alternative We formulation, who ongoing to subcutaneous most respect once with choice to to-date to times prefer Despite provide accessing one to to the With potential that, of franchise with patients expanding to to self administer. ULTOMIRIS turn neurology. an with pandemic. let's due challenging the weekly goal the

track to to efficacy two has by for make and with Our GMG of total treated XXX the new continue U.S with is increase the in expect at with serve III in for number opportunity this profile This a progressed to see or is additional risk and goal Building of come in SOLARIS With of the towards added within especially the rates success the GMG at a approximately team the market earlier ultimately we achieving proven for trial to the XXXX, this NMOSD and disrupt this of a move addressable in overall new population find in especially we the COVID-XX. ULTOMIRIS the quadrupling expand of record ambition the continues for pleased the our We of neurology, indications, products continuous target quarters, treatment progress enrolling possible potential in our goal. ULTOMIRIS late working number ways quarter X,XXX, in has with exceptional regardless of possibility patients key drivers team we on both incredibly of see I'm from year, market to NMOSD with regimen. forward expanding estimated the XX% expand free way patients of to the the we of and their for symptoms earlier prior considering launch early attacks. past pivot, path made relapse SOLARIS. in both treated we that approximately XXXX. to established to Since journey. light with neurology we XX,XXX providing value the and on the of devastating control patients GMG unresolved XXXX one Phase patients proposition population of potential four line fold patients suffering start by this it U.S. safety patients with patient XXXX net set to patient to patients, This the NMOSD success achievable, to have the in U.S of strong treatments. of by ambition GMG is the treat patients,

ANDEXXA Turning If who in and to face patients pleased faced able XX. bleeds, detail high to be I'm can to acquisition, these more or untreated, sudden of close experienced uncontrolled XXA patients rates. Slide often bleeding. life talk the following the threatening on incredibly mortality Factor left about the extremely inhibitors portfolio severe

So, Factor a when reversal growing advances patients get proposition. activity and care of both imperative health first through they ANDEXXA of solution evidence these and a these that clinical XXA with patients rapid it its the real targeted in that for is present body provides critical setting. value world quickly

these approved is patients conditions. treatments first of rare ANDEXXA with diseases bringing fit with As our the strong transformative and devastating a mission treatment strategic patients for to

treating operating urgency stakeholders. atypical critical of the requires Alexion The almost launch in HUS. across of in XX. for numerous patients this Slide space decade to significant setting since the care been alignment a Moving has

success atypically goes our beyond value innovative While themselves. the well the key incredibly in HUS SOLIRIS treatments have as both and ULTOMIRIS an strong therapies, proposition to

and work on reimbursement system encompasses stakeholders wide dedicated with to field focus support decision in access approach financial including hospital, teams all that a Our the makers.

with made by working large also across progress have We hospital significant systems country. the

continued atypical highest establish past in SOLAIRIS of patient impact to-date. to new has and adopted for and treating Considering this on already able ULTOMIRIS. large, a product that the This their ULTOMIRIS with work country, diverse the hospital consistent with has led generating profiles we example, XXX% number patients. pandemic HUS, system our have For to to the been the a of growth system recently, quarter teams atypical working in underlying HUS the approach a atypical on U.S. this testament the of hospitals ongoing both across the is HUS initiations of of in geographically

in bridge are of value we capabilities early we with ANDEXXA. to proposition While the days of integration, excited the are these

on see we continued Slide will see the you we announced to XX, have As positive deal momentum since for ANDEXXA May. early in

doors the support recommend the consensus renewal opened Factor reversal use. to oral And Cardiology’s an access as the in managing on ANDEXXA October American drip patients New updated Factor J issuance U.S. Code College inhibitors, now including over four XXXX, a XXA for anticoagulants guidelines of in and through for shift tap have preferred proposed agent of for PCC.

ramping in pronged creation. approach value focused for a up three be Our ANDEXXA, will there

similar our a from heavily to focus on important, atypical multi faceted that HUS to shift generation demand is a will still comprehensive weighted approach we While model.

are to on a Thought in focus access, across gaining and out are potential Team And access to resources IDN Leader We GPO be also to and capabilities ensure building patients capabilities providers contracting Liaison institutions. we enhance ANDEXXA. market health able will additional to economics high for support investing

updates future on fully, ground execute the our and some calls. take sharing will to additional I time running lay foundation, have hit to the forward look it teams to While

to for that, Ludwig like Ludwig. to with would closing back comments. over now it I hand So

Ludwig Hantson

of quarter, therapeutic the last and we growth. years. the business CX into The to Brian. new you, expanding to and few and continue the our diversifying strategy on second build In durability momentum CX focus leading base beyond creation drive main area long-term our value Thank on of compliment,

Management and of As This of average updated this enables includes strategy. annually we the the our engaged million share phase received objectives We year to free execution XXXX delivery $XXX against support shareholders. the I have our of Boards to prospective one-third to discussions have have we Directors It and million $XXX growth a XXXX. an with least us to is from in at towards new mission. shareholders. and commitment value flow want a through proactively from capital repurchases directing and appreciate many return to diversification, and note entered a of all allocation also that our result we of which heard cash being company

We the get also we that undervalued. perspective and share are the feedback

this that uncertain to urgency continue that as this the And into that, We year. returns of to momentum to to able to the pandemic discussion investors demonstrate resilience now have our rest will alike. proud continue shareholders call continue I we the increase to the this heads to-date diligence be of carrying adapt the and patients look COVID-XX value execution for will adaptability we environment. execute demonstrated will of forward I'm are months ahead. and forward significant Operator. environment. confident very our in thus and a face shareholder XXXX, we and challenging strong deliver I'm to question. far we in With open to especially the working closing, to in we with in to on more strategy, remain that In and look organizational critical

Operator

Thank ISI. question Schimmer first from Josh Instructions] comes Our from Evercore you. [Operator

Your is open. line

Josh Schimmer

taking two for Thanks quick the jut questions ones.

appose to it why a new return of starting then to midterm, a as why committing the are to capital with SOLIRIS III you not you pediatric Thanks. are Phase investors If ULTOMIRIS? dividend? studies in issue And

Ludwig Hantson

will start talk and allocation just we Yes to study. in jump want capital then about I with peak John will And question. the

cash of have strong flexibility free a as generation allocation, strong are a as in cost believe we strength I of we because said, flow capital we and As now a of strong management, pipeline. strong more far position commercial because execution,

and that a the flexibility allocation. us of strength on situation So have in it capital puts why is we

that years. have is we situation are talked dial least the or Why to sector a us share we increase or dial four cash that back. flow committed one-third our in. we gives made the a about towards focusing next up to three are commitment towards desire we buyback? opportunities buy this to on of because the buyback And So, of free was at

you we development and stay to While answer I Aradhana on disciplined know this? side, business the want

Aradhana Sarin

No.

few that for well the a is both don't balanced point. maturity we least stage are approach the buyback committing we think yet. buy and We for to the as committing this for company But of the we a at back reason are our Josh flexible. is towards dividend that to one-third are think And as as at not doing free next have cash to I flow of that years. at

Ludwig Hantson

studies? want do to pediatric about the talk you And John

John Orloff

we Josh, pediatric pediatric regulatory study tip requirements with a Thanks do is through regulatory ongoing data to study is requirements with authorities that these ongoing Yes, an regulatory generate have SOLIRIS and interactions that in in our generally commitments, post are the MGXXX other population. now marketing again

Ludwig Hantson

Josh. the thanks Okay. for question

So the next take operator question. we will

Operator

you, Thank sir.

question from next JPMorgan. from Cory Our comes Kasimov

Your is open. line

Cory Kasimov

Hey taking franchise. first sales consider guys. I I my to sales ask your When question. half your about Thanks CX good think the were, for you X.XX wanted morning guidance. for you

annualize If that that your the you get range over X.XX. is X.X you to in of guidance little billion versus

patients neuro. especially pricing a it But So, performance as still light, in SOLIRIS’s there strong conservative, dynamic is is convert ULTOMIRIS. to different in more obviously, seems continued

do anything conversion a pipeline there sub or you. else just And I'm a the indication? more the already for XXXX start you and on PNH our I'm plans given you So, year-end. really in is then in demonstrated before that you something confident or HUS for PNH like if Would consider Thank the missing, CXG profile the accelerated that. remain curious PK/PD have just as quickly such III there to waiting data XXXX regarding optimal trial you described Phase on atypical in

Ludwig Hantson

see And we the lot complexity Needless think a what guidance adds about Thanks for and our talk to do adding in might continued there we let want within talk continues the the in marketplace. competitive, Aradhana see competitive say we year. start questions also the forwards I tell current Do in to jump about, the with you the to be moving that for growth a to that industry. this? but believe market top-line Portola despite little it in very with a question, item But COVID-XX of our yes, bit he environments, Aradhana very the questions one I patients, build with slowdown, new and we the to on before operating me a we strength are continue can uncertainty forecasting. you uncertainty Brian is to of strong Brian in and Even business, see but situation and can give be margins XX% but the and your Cory I

Aradhana Sarin

Cory. Thanks Sure.

rates, which for So, various haven't second you the in there it are more our a very is our the definitely right impact seen closely. but but One are we is is are second quarter, guidance monitor that we little factor variables monitoring. that constantly half compliance conservative, that obviously we a

patients and for adds, takes as time the can new getting is to queue and patients The from the patients time of second of identification which new the reimbursement, actually it imagine you on vaccination, therapy.

great well. back forth. uncertainty we go which rates profile is we given There ULTOMIRIS, is is our The And, a and know seeing payer around the fourth So mix as the sort time unemployment patient have time with And yet. to to year every access for force uncertainty forth. mentioned, of The watching and you through. is mix, Brian theirs is overall, a the as ways so so and the COVID again field payer second of in the bit and half takes third and been that And slowdown to takes week then are there lag not the of conversion little the time which ULTOMIRIS. is eight are new adds.

guidance all try a exceed. or company, to taking as meet set is we we our into based So which generally guidance, on. And, account those what is can factors

Ludwig Hantson

XXXX the to you proud do XXXX, you a what question fine. of talk on has done before about to I'm and quarters team we go see Brain, maybe little can bit Yes that months markets? commercial tell want the the very you what the in I over

Brian Goff

really the Yes well only end and been on covered to it I Cory for think The a to note. thanks add, question. is I positive has thing wanted

a we more in to have virtual Here continue quarter lot, full we the in teams get a pandemic through are learned and effective engagements. the their

well. are couple got spots, started a bright see we as record journey. is track initiation. then of you atypical to I quarter conversions present noted, as but And certainly of And in have physically I mentioned not ULTOMIRIS had the on We first a have really the of what continue we with HUS, secondly, in new terms had all, of offices, terms in that patient fully

So make. trying about we feel continued monitor fluid is, to we are the that progress very to but continue as carefully good every we company

Ludwig Hantson

Okay.

Cory. will your take question second So we

XXXX, So XXXX PNH. John

John Orloff

in a of regard results we Phase deciliter, well per recall very now to transfusion. II reduction showed with Yes. XXXX that program, strong grams a as D Factor for Cory bump the the requirement nice hemoglobin in had X.X as that danicopan with dramatic so

hemolysis a that second of trial add will with on with data patients therapy in either have and PNH extravascular a to So population Ultimris, that we as will based year. III the this or Phase be Solaris co-existing, proceeding the on start half we that

The you explored our based and confident know, remains program to it as optionality in both adequately which actually its determined. hemolysis, whether XXXX a and be can control monotherapy, evaluating focus PNH So there the intravascular on Phase data. Phase in being III for program, extravascular is is II hemolysis also on

indications. course, of expanding into XXXX about also, most with are excited We additional

Basket other the starting as and Nephritis, be will membranous our in well indications are among other next Nephropathy, will IgA right looking pursue might nephropathy. at that areas we could We include there half now. we Lupus first be Renal of that and year again, potentially trial disease that And

Brian Goff

CXG that I data. And would the add just

XXX had higher a had there meaningful analysis to relationship internal targeting in was as external on achieved impact that inhibition. on subset Factor. as pharmacokinetics and PK/PD I spontaneously. study alternative would It proteinuria is Factor regard as data who experts think which to patients our the been liquid over inhibition, And advisors of have clear both not difference well pretty the reductions in pathway in that there that complement pathway what alternative phase with patients meaningful such reductions based BB XXXX, that D PK/PD proteinuria, a phase better XXX between in a that on realized half is as Study well we believe is they in solid did XXX and with with

Ludwig Hantson

will question. next the we take Operator Thanks.

Operator

you. Thank

Our SVB next question Leerink. from comes with Geoffrey Porges

open. is line Your

Geoffrey Porges

results. Terrific to very Thank congratulations you much, and see. the on quarterly

question. from financial So, deployment the capital the -

issues in offset there least intention but contemplated the are still initially is COVID, that to just you to long-term there? most an seeing be your are with that helpful reduction First, stock by with And then achieve count share around whether dilution? a at providing employee host COVID helpful affected be do that, year have to considering. you option know And Are you this it then to indications that year guidance? absolute the know expect Obviously, this would buyback? of Or where would was something related were risks you know just which just and geographies you to

Aradhana Sarin

Sure.

we So, this the is provided, strategy is what say employee stabilization, allocation capital stocks. clearly of year in excess even that share from the offset for would dilution we that clear to

few next of one-third, next what expect free the flow several smaller amount or is we that the a our years for for again is cash least than we one-third which only So, years. where said this at for year,

question. So, your first was that

was, really with relation it. COVID. to what question can under I will being is take see advisement by geographies that. third we guidance? But we I provide provide impacted more long-term your and are much on plan and think clarity comment that And your and can't With second transparency do we which how obviously to question, information

have a So, digital strategies of mentioned, field Europe means, Brian essentially the Japan. still is lot which to as field and to In the and we offices open the our same. have and calling efforts pivoted we force and more is force some lot our obviously back not the in a U.S., of not starting are the of

using I think you continues. days to I driving explore how more know we our mechanisms physician to different the don't now and this means add tools breath. want depths new lot instead long a question. to knowing right to engaged of third So, are of continuing keep Brian, if But not

Brian Goff

you Geoff. you stratify the probably indications if morning, Good terms I of and that expect thing life would it would is way. of what The threatening status is only Yes. add severity in

I an know, mentioned, as continues So, unforgiving that as, not to se. acute track on is HUS per atypical dependent you testing it well manifestation, really

a prescriptions NMOSD continued of aggregate So first side function less progressed. within is unfortunately on clinicians. GMG and be our that always new of so severe on less neurology, nicely. and And prescribing to GMG but generating has you very depth time thought to progress just focus, gave numbers, so we the continues i.e., then breadth, NMOSD with the than more is

say that would that an how indication depending PNH then I part, is and volume. on is disproportionately it testing So in large breaks apart is

COVID So see imagine, in PNH impact you can on subsequent to you as will the testing well. that era as prescribing starts a slow as

Ludwig Hantson

Operator, Brian. you, Thank next the question. will Okay. we take

Operator

you. Thanks

Our Chris from next comes question Raymond Sandler. Piper from

is open. line Your

Christopher Raymond

Thanks.

wanted a of Just to questions here. ask couple

with understand it new is up guidance sort I'm is just million. OpEx, what of trying on this to $XXX midpoint-to-midpoint involved First

and of about walk that you of million. maybe out driving And a what think to that, you that. of from the and answer field know, have maybe you indeed in mentioned MG? seeing component last think but if in that the I can guys takes, clarify, kind talking puts you NMO about about of COVID-XX Portola and XXX your the is were indications, that the I Thanks. more talked through of XXX to are lot differences but I clarify, just is question, back million then up resilient disruptions just you you just is sort

Ludwig Hantson

to Aradhana you the question. take do want first

Aradhana Sarin

last you had that the from that controls given and And we quarter, quarter. OpEx, of were actually were involuntary. it various Sure guidance we various had to commentary think talked changed I some in last about comparing remember which the if you the things on of some OpEx

and related expense expenses TNE so conference example, and For forth.

on actions the internally OpEx. taken our several and And uncertainty manage the we actually some have that because to were into of top-line it of buying voluntary point,

studies and part perhaps the other is given had delays therefore, anticipated we of The the OpEx OpEx also guidance appropriately. in

However, now of year. number actually of studies in the second expect start the to half we a the

then, are And going of of also R&D up. that imagine mentioned, XXX year, can in half will the Portola second be as million you absorbing also OpEx. So expenses our we

the guidance those the is So to elements from why are it the from last as quarter. various different

Brian Goff

to second conversion. less just is with clinicians is your expected, the be go had a Chris, generally, to as the of perception longer GMG suffering that neurology is Unfortunately, within through. on them journey obvious that question we patients Yes tends it the many

is disease, convert to it unforgiving lot so, are over those breaking attacks a And on therapy is convincing devastating. lifts of a when highly to it SOLIRIS. of happen, they oriented you is a NMOSD those immunosuppressive and cycles it know successive as lot event educational is

nature and continue would of the during it access less so to era, And I COVID convergence it play in terms center expect in to to acute out and way. this more the of physicians, front be tends will that

Ludwig Hantson

Okay. take thanks next Thanks question. Operator, will the Brian. we Aradhana,

Operator

you. Thank

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

Your open. line is

Philip Nadeau

over a specifically couple on congratulations of It quarter kind of and XXXX like the the first, seems behind would me are the you to hopefully for term going Just likely such and XXXX half on be morning, second headwinds as SOLIRIS of and guidance. convergence pushing COVID questions going certainly have ULTOMIRIS. highlighted us. and in Good COVID trends two patients, longer to like the from in conversion It seems XXXX into and be

affect is the patient is that from you that reasonable of revenue in do So, intermediate ULTOMIRIS you GMG for ULTOMIRIS to to light it then is maybe will competition where the opportunity data coming? the question second just broadening pipeline to How have population Thanks. is highlighted, FcRn's. that in us paradigm expect acceleration over think going ULTOMIRIS’s saw recently treatment and in on FcRn And term? fit

Ludwig Hantson

guidance the within MG? to ULTOMIRIS and you will go and long-term Brian decisions John, could maybe take Aradhana, then Yes, and

Aradhana Sarin

Sure. Thanks, Ludwig.

obviously to apply year give as will are on your it the guidance we what same as in for But XXXX factors well. I for could relates next question So, a position not for year. next we anticipate to think

year the you determine the being on we ending the of will see across indications, are and rate. of first patients The is. we the where And this landed various at compliance rates compliance what our the of therapy imagine towards if where number end and all what year, end can XXXX

adds also new queues. hopefully the will and away, the COVID with we think see pickup fading a new patient I patient in

XXXX continue be factor Your And will may of fourth behind PNH. I some that right the really strong going atypical that to in also out But and still that conversion as ULTOMIRIS into we the in would well. year. conversions and ULTOMIRIS was the have time you fear next take HUS which then the to and play fact mentioned mix, have may in

we that to those hand are I think will Maybe, well. four -. over monitoring factors as an constantly I So, next on will major the and effect have year

Brian Goff

insurance. So, operated competitive will new a to I to about What insurance or are in, neurology very alone. analogs of for there competitive in new U.S. how volume when jump do patients potential interesting RA, in will we is, largest see that the and you come I just particular great examples GMG had there we for with on the first continued many in market this all, XX,XXX as the is mean, years. second at show MS, XX,XXX example, the to in are grow look market. certainly of question large It is be

as That pipeline that alike. about interested and we different own option, talking immunosuppressive spaces. high namely, GMG, are we of see FCRN modalities we likely IVIG more very severe in so out steroids, our occupy first certainly case towards because and well less expansion position And more are are potential dose controlled and is the the displacement, with line therapies, well. patients with SOLIRIS, as of to in different

a is price hemophilia then therapy. that disease this experience do unique different world the a return firmly treatment about some waiting the wind of we taking bridging playbook of a then with up little it approach. and SOLIRIS is in a patients and not that retreating. And is ULTOMIRIS bit this if symptoms unfortunate is the until to other is out in thing And, it where So paying the chronic is believe continuous cyclical given very

XX,XXX we rest will continuous the mention patients. on last that we I in have to we it of see static So the the up any are And expanding, be is therapy. we intend I the as mentioned, about making. then of ULTOMIRIS just With thing progress significantly aspect could quite to addressable don't market are

Now concentration, higher two and subcutaneous working a ULTOMIRIS on are discussed. on we are have years in as working half we we plus

in have looking including We Factor assets other at, will that pipeline we the be D.

intend grows, And so as patients. this those we market continue innovate serve to to will to

Ludwig Hantson

to do have anything add John this? you to

John Orloff

know, as over be the are would GMG we now, ISP. add aperture, trial I to are patients XX% opened thing that are and not actually only patients going an have that enrolling failed who you so enrolled The has we Yes. enrolling is

are moving in earlier of course the the we So disease.

opposed the I a XXXX, pursuing we In FCRN therapy our of treatment that to at to response said, a but throughout and will program addition, be of as will dosing with avoid out carrying MG effect be as cyclical looking interval. continuous own duration therapy, loss the we full

Ludwig Hantson

Thank John. Okay. you

more We are at the top of the hour, so will we take one question.

Operator

Thank you.

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

line is open. Your

Geoff Meacham

the Hey had for few. on a congrats guys, question. I and thanks the just quarter taking

you starting is buybacks. us Thanks both for and the with you Brian, Can Portola on guys. emphasis just Should then as that to we as the So with real of now in new strategy the like mature? view have dynamic the and I maybe switch do terms allocation BD pricing, behind for the maybe this capital optimally? ultra, nuances you with help de-prioritizing you prepare quick, HUS, Ludwig, U.S. the and you launch pipeline

Brian Goff

first will ULTOMIRIS. one about I Geoff start the Yes. on

I one between differences in we with that guess launch high that quickly lot institutions U.S. underway the atypical and the have First new I the the and The HUS of see ULTOMIRIS and are would clinicians. all, level of just HUS, is we Germany. a about expect what we ULTOMIRIS already now don't atypical thrilled in not many with is for to of Germany advantage is

has is pretty that just for years. our conversion to with so emphatically ambition two really have PNH. stated will with within or that continued HUS XX% why atypical patient have expected patients And ULTOMIRIS we And, facilitated as it deliver I

Ludwig Hantson

capital on parts. Geoff allocation Yes,

of and strength are of but also in because the we situation which flexibility strong now with the are that have our much we because the said, is than in position a R&D we I stronger execution, before. As

programs and have know John lump now by launches in XX was sum saying, development You as for XX We XXXX.

less has this rely very critical development. pipeline now discussed as as to short-term external we BD innovation on for our you during and our call, have see really focus after when And external delivering to organization going you business that have strategy that drive after going look that been source at a a are quarter we the strengthened significantly, over are to this So, and quarter. quarter innovation we had quarters has

we going on and focus really for the the of maximize quarters, next that to making integration are sure assets. the we Portola So,

as we development share it you have I are rely towards discussed, so going above and focused less So, what on approach remain moving means drive with much the up side, we if said, that we forward, more being to buybacks on want will business but the can to, on that see will disciplined. we opportunistic internally we we one-third BD a

changed. has that not So,

Ludwig Hantson

even So, I'm team we this going over you say, looking to or us has on with we this joining we on delivering progress. are what delivering said that, to do. thanks informed our of Needless what are to for morning. forward achieved quarter-after-quarter proud keep very And

calling of rest your everybody the day enjoy for and in. So, thanks

Operator

concludes this conference for your Thank you gentlemen, participation. Ladies call. today's and

disconnect You Have wonderful everyone. may now day. a

Alexion Pharmaceuticals (ALXN) 30 Jul 202020 Q2 Earnings call transcript