AMRN - Earnings call transcript Q3 2021

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Operator

Welcome to Amarin Corporation's conference call to discuss its third quarter and 9 months 2021 financial results and operational updates. This conference call is being recorded today, November 3, 2021. I would like to turn the conference call over to Michael Kalb, Chief Financial Officer at Amarin.

Michael Kalb

Good morning, everyone, and thank you for joining us. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. include based not us on X, statements these to today, such XXXX. are statements information of but limited are -- November Examples available to or goals, not our in out achieve may statements. meet our We our expectations actually forward-looking plans intentions disclosed or the carry undue or results place differ these statements. you should materially, Actual on so could not events reliance We assume circumstances as change. no obligation statements to update these

joint not transactions as terminate. do statements into, reflect or dispositions, we mergers, enter forward-looking impact enter significant the agreements Our of material such may into acquisitions, may that ventures any potential we or amend

everyone For ended factors been year of with of www.amarincorp.com. use see actual competitors. new the information prepared XX, current Investor And section you I annual nature, to potential After section. this in our ended will September provide investors, remarks, XX-Q is open this of calls quarterly call Form filed the could remind listen please our potential and through in An results and section that will not Factors cause more Amarin's discussion. Form This existing Amarin current and results. financial our of for typically our President review I our will XXXX, for the employees, and investors, potential and Officer, investors SEC encourage additional read which lead Mikhail, collaborators the will including of XX, your concerning promote and at audience the the on to the we multiple on questions. XXXX, are VASCEPA. Amarin's of the be posted available to the Karim call call Risk is Relations archive website, Investor Chief report report detailed Executive Relations to intended December materially, website intended quarter these documents. have to XX-K the differ and on that for We a

over attempt will review without the to and for I we our competitive call positioning. this in Karim strategic business. compromising call information a provide always, As to constructive Mikhail the turn of now

Karim Mikhail

joining Good morning, and thank morning. all you us this for

commercial shared and drive VASCEPA quarter, in Last diversification; X-dimensional you operational I for quarter the to toward awareness critical and and in well commercializing successful we including over enhance progress to risk cardiometabolic at-risk our to XXXX VASCEPA/VAZKEPA player to Amarin, its for strides goal in go-to-market that the the I or taken to Europe mid-September. we by evolution. with made reduction number world. product our for make led continue was highlighted patients Today, of our demonstrating strategy a transformative The CEO indication. important report bring cardiovascular position, on benefits the These depth to of achievements third we I'm just become underscores CV vision geographic risk had the the strategy: in VAZKEPA quarter market. the commitment as the strategy, progress growth the U.S., Germany when representing around advances breadth, on designed branded were a our are height, way the the by milestone And executing demand meaningful to reduction made it's launch our our announcement by as This envision. U.S. was we've global happy in of followed expansion; we which

of morning, for review net press revenue we our with is million release revenue results months begin compared million of first me with million this quarter total VASCEPA. saw you a of The quarter. revenue our the of We of reported in $XXX.X XXXX. in year-to-date Let U.S. for total period $XXX X bulk reported Starting same the XXXX. sales product As of for this third the in million of $XXX.X brief $XXX.X revenue: with our XXXX third with compared net the from

our support remains the Mike expansion in discuss growth U.S. VASCEPA later plans. sheet, franchise continues to our will profitable, as our and and and Importantly, call, strong along balance with

dive a a particularly been potential the the Now for deeper quarter, U.S. market market. the for of competitive This into number growth impeded a U.S. has as dynamics in and challenging

First, quarter. the to X% the visits caused and the impact lab research with variant X%, of COVID-XX visits compared prior and and by patient respectively, Delta drop

lipid the the weeks first market Additionally, quarter. X of flattened for the

time, factors let first better to so through COVID-XX quarter. pandemic hit, indication and access VASCEPA to to dynamics risk before driver the thinking. them. on for of the for building for is for access reduction Long reevaluate key you improving more Perhaps the plan a the and available physicians physician the decline. its and our cardiovascular understand growth on our opportunity generics created develop We biggest engagement. to market These the an significant was tackle X adoption and me the to the there walk entire to gating Finally both strategy, were need needed

For physicians XX%. end X. example, fallen the out of to to Access according Monitor, to By XXXX or that approximately XXXX, was access X of about XX% ZS' had in access

field In days and in X out physicians the other X near on accessible words, for early the at of XXXX, is quarantine those the X%; they by currently During at force. only of less visits stand were levels average XX%. than

more. number We the enhancing strategy impactful VASCEPA e-mail branded allowing in in-person include platforms medical employs care visits campaigns, they almost provider risk detailing, by CV efforts CMEs, model of messaging and XXX,XXX offerings reach significantly and use U.S. a and virtual to regarding portals, of through educational this new of reach want. with and platforms them Simply, drive our to in prescribers websites our our as ways and increase target customized high-frequency, prescribers robust VASCEPA for with patient's greater customer digital and use of benefits digital engagement to creates far digital the reduction. intend care significant statin the variety optimizing to health omnichannel and digital us a approach health force enhance efficiencies these the of our improve sales to to the These a professionals, integrate engagement and Our media promotional social a of such

of managed is area care. focus next Our

While exclusive several prescription we access improve Medicare patients real icosapent Part ethyl VASCEPA payers and with to need. as to VASCEPA D commercial intensifying currently remaining product, cover to the efforts are large remove barriers to medical

access. drive in growth are ability focus to continuing by volume We confident payer enhancing on our to further

not Finally, risk our between VASCEPA reduction. last, focus for approved in clarify to Generics difference of indications is area the generics. the important equally FDA cardiovascular are approved and

by the generics market particularly and VASCEPA indication eliminate of taking for educate pharmacy are uses, level. regarding non-indicated the limited the substitution We a the to the of created of variety steps generics at confusion with

to for minimize enhancing we to all continue within end our from progress. some references and reduce U.S. inaccuracies optimizing underscores narrow generics prescribing compendia Our correct factual and expanding complex managed by that VASCEPA care. X time, the goal improvement: of physicians in non-indicated usage the retail substitution pharmacy Correcting to in are access risk prescription to we September, announced And believe we used our areas a and in CV ecosystem what significant commitment platforms key but will is for total is label e-prescribing approved their difference and market care go-to-market order addresses above. the physician be for transformative systems systems, the reduction. to we uses for disruption a the it will making can these keeping any patient expect strategy, take process. And access, At within we which engagement make to

flow end-to-end to to goal ensure prescription Our prescriber to deliver patient is and a streamlined manage optimized experience. of simple an user and platform

driving a of purpose our these focused are decisions. while While new the early their with implementation tracking in and sense initiatives we will go-to-market days, be reevaluating

prescription resulting forward go-to-market We usage, increases? reporting expected impact. will measurements in these are by confident urgently Did as these all it for unfolds. successfully we be strategy this successful We Revenue. and impact? deliver revenue on and measurements did this ultimately, have success: that more look X initiatives provider Did produce front to And patient Strategic and and their new they implement greater initiatives? execution.

We versus to successful, allow initiatives also entertain and could which, if continue differentiate us strategic generics. to numerous consider further the feasible and

believe early generics aimed efforts U.S. significant ourselves the While on would future impact stages, that such versus have potential at in the truly differentiating a we in VASCEPA of

in our to now Europe. progress Turning

the in third VAZKEPA demonstrated global to Amarin a quarter, Germany. of commitment During commercial its becoming its launch player with

it entities in a patient with regulatory announcement, we that is a have population that year a As not over Today, since self-launch We Ireland, consistent announced little Europe, no just no VAZKEPA. label had commercial Europe reminder, an August broad the EMA-approved when REDUCE-IT. legal have presence. of X in no beyond totally for even infrastructure XXXX in we and did Amarin that would approval

including XXX our branches, Zug, XX commercial and employees; have We launch Germany. initial commercial a in hub legal in and executed entities have Switzerland;

medical are more scientific professionals that We for by proactive top launch we with the a and leaders events illustrated were both to of a Germany our XX by limited in continent. able launch days will to every to our renowned these than proxy Germany to and year-end. our VAZKEPA engage, audience. cardioprotective introducing and strides is market stream virtually, teams physicians successful specialists have The to ready the team This targeted events on and a more is the to our from promote an to and across hospitals endorsement execute schedule. early our societies; very believe and was especially ability and and successful was care And XX reach in such many thought expedited be led the physically live with great in a next effort the from The made conference physicians quarters, pleased to target hosted and more attended German internationally debuted access plan. launch to before for health that Germany, scientific teams COVID. to date cardiovascular the educate with by In of benefits best than as audience person XX making approved commercial and XXX the VAZKEPA couple key is still due

small in We time so the Galenus to or is portion prize included X be have a COVID-XX paper we prescriptions achieved of important German product We VAZKEPA achievement is step Prix Pfizer, submission. Prize are been awarded very the finalists making Pergamon their quarterly more scientific for in as X. readily the Germany, went the effective This Von of report today. recognized which an particularly represent prestigious October Galien X prescribing medicinal for innovative to prescriptions in widely were honored been that at total has electronic pleased updated been are approved BioNTech, for Germany's VASCEPA of accessible, second This for to in we have press. vaccine, place to honored has a Germany in a prize truly year's that and this system,

We the negotiation of file on communicated XX initiate to all Now France, goal are previously Denmark, Those Netherlands. our Amarin report access the XX. market level. markets already proud to process XX dossiers and allows really that Spain, is largest have regional This with Europe. I'm to by U.K., a Italy, we in year-end, Sweden, reimbursement submitted the that Finland, markets agencies Germany, the and Norway European

based country-specific monthly. uniqueness the included The have next on of I now for we data next and pricing various initiated data confirm lines exchanges several can our perspective, and list VAZKEPA the being XXX also will countries approximately the targeted that patient wave update an and time is We engaged submissions in population EUR will approvals. with define calls, on to in expected these of scientific demonstrating earnings the or eligible extensively already from include additional same X and label a reimbursement all countries, demographic submissions provide $XXX country of of XX Europe. our

Eastern We initiated we or Greece. steps the identify first have countries, to with the plan in also the to collaborate partners Europe partner Central with starting

same been have agile, the time in in and in investments prudent the yet fast year, Over how at we past we infrastructure measured built Europe. have

focused a treatment the belief in paradigm tremendous organization to markets change driven that care across by Europe. our our preventative opportunity exists structuring cardiovascular way, and prioritizing are in We a

cardioprotective X-launch in of relationships access. phase, Germany, important vast education on that the the of means our and establishing the majority targeted professionals market we are providing we negotiating Beyond markets, health which care with benefits VAZKEPA are in

customers differently be aligned an strategy successfully face-to-face the digital-first developed tailored our each us and quickly not all to implementing of and efforts. cross-functional behind ecosystem technology easily we've the of same, The customer We are to the it bespoke. market one approach Our us navigate recognize all to our allows to enables single channels model us complementing allow that markets individual field that must our integrate force and and commercial access in capabilities adapted and our have be while the to and digital engagement can plan. our specificities

excited about VAZKEPA that problem in as per health Union every very the common are and million the We for billion deaths increasingly year. Europe, year in CVD Europe opportunity causes an is XXX costs EUR X.X European

Our across Europe of cardiovascular we're residual risk is for mission small to rethink the treatment challenge. but the feat, no up

We are a of won't in the a lives to new Setting high-risk new across CVD. standard Europe committed cardioprotective establishing treatment patients improving for happen cardiovascular care by overnight.

and got the the a confidence to that have the the strategy happen. high people level of it we've evidence, we However, make drive, scientific

to pursuing. me we ambition of XX the have worldwide. access approximately cardioprotective strategy and We to the the Last other are have let to currently turn mapped multibillion-dollar benefits international the we of the Beyond top Europe, in markets markets significant XX. cardiometabolic obtain in XX opportunities these now our to quarter, access other bring announced market VASCEPA/VAZKEPA to potential our

Our will take ways. in plan X place

Israel. plan when filings begin XXXX, to and up product regulatory and including will obtain The Australia, New we X countries, to in approval in first submit Zealand

second when The wave to X up we come seek will in will in countries. XXXX, approvals

of study and for we the follows will approvals be FDA by will XXXX, the cardiovascular third approvals VASCEPA/VAZKEPA when be EMA risk the countries remaining targeted. from cardiovascular The we These in reduction data in supported have the wave long-term indication. X all filings REDUCE-IT outcome and seeking

Such language be specifically broad these label have of advantage the will of marketing partnership. EMA our collaborations In potentially We most will giving we all our opt for these optionality in seeking a reach agency CV authorization has We providing control of countries. of over markets, to an the us markets event the as these expanding additional and millions the a represents of at Amarin to and billion. opportunity globally. potential of patients business benefit grow of $X around product we market XX believe distributorship risk

where China of have end VASCEPA Kong receive XXXX. markets the to international partner, to other in continues partners. Edding, approval and to we on China, Hong of Moving already near our In expect Mainland

in With Edding launch XXXX. these these approvals, has in territories plans to

As X in Europe, the U.S. the launch Chinese will with the support societies. and key VASCEPA of cardiology

for and and in for good Pfizer known this the pharmaceutical for statins well sales more billion, physician will new need in well collectively in physician the approximately a risk name disease both at than and meaningful on excellence agreement should primarily XX agreement with primary burden opportunity a force HLS' Pfizer August of the the XXXX, personnel as believe partner promotion specialist VASCEPA Canada. CVD is Therapeutics, a VASCEPA to With VASCEPA support respected for of China focused existing In patients physicians X in in staff CV of medical branded remain and audience. to in $X primary industry. is selling with there announced Canada, We our a expanding and is China. significant bode field market Canada, market HLS the promotional care care gateway

share thoughts me let around diversification, height on perspective the some dimension. our Finally,

review We all in the obesity cardiometabolic space. continue our potential and systematic of assets

disease spaces, We and in considering remains that where not ourselves populations need. to including alone. the lend primary assets, tremendous are rare care limiting and also unmet unique those We're specialty themselves large there to

of potential assets, with that significantly assets stage transforming and and We assets portfolio. are prioritizing enhancing X types our potential have commercial of near-term development the

this focus due on to can our cardiometabolic time; commercial As scientific, diligence. space, process and requires appreciate the and and primary financial you

With over our future needed believe an is and for let important Mike? resources business, our more We this for Kalb, that our the overview of discussion Mike growth. continue turn detailed of leverage me to are the call this to dedicating financials. a CFO,

Michael Kalb

Karim. Thanks,

the the During of X% $XXX.X XXXX; reported net million the decrease million, total revenue of compared $XXX for of and XXXX, a of of X% over same third of quarter XXXX, XXXX. to months the of decrease a quarter third period X we

of of the quarter During generic impact the decreased impact product for VASCEPA's products to net compared a million, largely XXXX, sales ongoing driven a as result by and U.S. the indication we of revenue third initial of $XXX.X decrease the VASCEPA which X% the quarter XXXX of of COVID-XX was of third reported pandemic.

months partner X for achieved U.S. initial in of decrease $X.X approximately an increase launch XXXX, an the first of a included XXXX XXXX $XXX.X of Canada in million. in VASCEPA driven we order sales sales which the of of million, in For million Canada over which offset VASCEPA $X.X was X% our period partially largely in the by to a in decrease same by

However, the profitable competition result quarter as believe the U.S. in business in decrease, revenue U.S. new the in this the our the around will U.S., our that U.S. Despite and that the into VASCEPA generic profitability our continue a of the of the geographies continued support expansion for be growth as despite operations to management. U.S. noted, has this need to Karim market. is high we The in continued expense Europe third patient go-to-market and strategy world. other accelerate

to due to these of variability overall short initiatives, term in spend However, fluctuate. our profitability the the may related

and charge the of U.S., and the Additionally, net achieved our Europe. in we strategy absent September would growth shows U.S. $XX.X both XX, that XXXX, for the we of go-to-market ourselves positioned further have related the X in income for which months transformation the million X have ended throughout to onetime both

inventory issues products. shortages companies ongoing monitor to which in the chain for continue numerous and global supply we Additionally, are supply resulting

global demand. While meet by focus to not supply shortages, continue to we expected these maintaining on currently we impacted the are adequate

U.S. long-term and of $XXX.X our of million, $XX.X respectively. world. overview, countries the that and equivalents to September will remarks. successfully call cash the cash are financial VAZKEPA Europe turn continue of international million throughout and and aggregate believe profitability XX, of the As $XXX.X current resources With and $XXX.X back We sufficient I Karim million closing and other launching reported XXXX, liquid consisting for Karim? million short-term to and to investments of cash support throughout investments Amarin in now

Karim Mikhail

Thanks, financial overview. Mike, the for

and Now in to approvals road in on in road goal shared successfully we map our for collective for VAZKEPA these the as goals I'm our is XXXX. keep and future, these as have call obtain over of execute be ready success, believe that value ahead our ambitions the U.S., multiple the operator, Amarin strategy that enhance countries launch build we're countries in growth realization We eyes to value Europe the shareholder With that, will will our regulatory of reinvigorate to questions. our we for the new company confident number a achieving in for the open time.

Operator

And coming from first is from Piper Rahimi Instructions]. the [Operator Yasmeen question Sandler.

Yasmeen Rahimi

a Congratulations into thinking the they soon how would of the and Karim, schedule. we bit filing little dossiers about ahead it. on understand be love should would place -- of be should more how dossiers XX and to cadence these I XX put

be cadence dossiers months, those there helpful. dossiers continue in X -- an that to launch next hearts countries? change the will to place. still potentially would all in give start is, would it market you strategy Or could considering of of building And partnership? on these then question the of second do you as you just could of potentially be XX is are and confident of be your expecting So Germany, that a is now very own? like in in the So are launch idea that That over we us be you granted

Karim Mikhail

Thank you, Yasmeen.

of So of files require, the don't speaking were it the The required and some submit are up XX, huge. that agencies patient these work that is population those in in cadence, XX analyses people Maybe magnitude, analyses to already imagine X gigabyte right? specific great of that XXX our they REDUCE-IT. include it's the is dossiers, we able, amount on of but to

we great a fact is So have we that already believe, submitted, milestone. the

attitude and generalize Now different with these them a because process files. towards going time different a line and even very to of all next dealing steps, with are very countries and regards to I'm the the have XX

a they're are clock, preliminary with XX clock come actually coming XXX point a us a back a in reaction. certain usually of of of days have to Example most have group these in to back You a have the countries them response. a us time them to to Nordics. that meaning tied Usually and have to they with at

And Some questions that's answer of to these preliminary part immediately responses step two. going and be a no are then move strategy. because to we their of we their

we earnings received going But of time why those clock. take call, have a have you is that So a how shorter and a already have by a to clock. about be earnings but a just in saw provide don't have reaction XX all countries feedback number A from engagement next that in few It right? are longer, this next going, a this that a clock. have our by dossiers take really agencies. to a with earnings That's questions. many, said we is it's And direct clock, we did because, we time, regards those talking in ago able we where their minutes responded. of detailed with to France on to can them line we in We Italy approvals doesn't script weekly call, XXXX. of will are these long us. basis have all would doesn't receive

Some might early. come

on long remind everybody might if we the that on come will negotiation. depend Some a but later, will we're the we to on I'm term. going faster go X the to may percent," "Oh, reimbursement, discount and I and say, have not this it build shareholder that concede price is willing sure value and all

taken account. that be to needs So into

cadence the what few over we on dossiers' that's expect next XX the and So months.

have Germany, a already planned in for and launch Germany. of in terms self-launch in Now invested we

the of it's the big If I the as and biopharma. in put, size of field robust you we players compare the the force, think built, many the as as key investments we infrastructure

always give we around ourselves do because do pretty we us? yes it's no point talk Now There's no. they time in We're And or thing, we're At still in calls is restricted of challenge when partners Germany, we will ongoing basis, This whether business. and this the On launching. this. to doing phone right? right answer dogma COVID.

the out to that reached not the our on audience a have we've everybody fact despite for few market target today been in We until months.

it point or we best is the else the really market. surely. will engage So look take the we societies, us that happen in anybody to this German leaders. why That's we're saying ramp-up the the the And in time at, endorsement from some we're believe that from at slowly proxy scientific time can the that support but and will getting

Operator

The from Roanna coming SVB Leerink. from is next Ruiz question

Roanna Ruiz

curious generalists, question color prescribers And cetera? more on. quick or Germany. practitioners I focusing the they of wondering physician number of VAZKEPA? I'm if high-volume on what elaborate you Whatever specialists statins. targets can specifically to you appear of et types was you're A on prescribers of more Are early if provide. be could possibly they're

Karim Mikhail

Thank you, Roanna.

on granularity launch: So did we management. specialist in involved cardiovascular cardiometabolic more German to really give so is that risk the the and target every

between really private we and basically cardiologists, So basically, XXX%. hospital cover

as segmented the patients. of and significant That's are actually more volume, a XX% we in used so and are who point the business, of very to beyond in cover key to of terms who traditional the target, the ones way so targeted, we this the we physicians importantly, practices, percentage to because new cover not a audience. to target thousands these the style In criteria, allow business, willing and they're in had their but pretty of us that which is we the the it's the prescribe restriction, readily why with tens support who at EUR what go products time, that innovate are prioritize, the to potential are X as EUR X innovation GP

to the to deliver we of not that not and that we us X, visit prescriptions, because, focus have use. because the deliver market, times, X, the you our until X That's to truly the to and to Definitely hardly we maybe for D, goes physician product just the the able bare some, a engage, is maybe truly were minimum to to right? on And need the this or So B, have the dialogue. lens X X. target, C at you on to get least to have A restriction,

that of [indiscernible] meeting that's strategy out the Difficulty] you physicians So to number we're that's events it's because having another tour. a [Technical [indiscernible] saw to one-on-one communicated that reach we speaker

So when you the speaker attend. number launch went XX we who can significant that after physicians, is do if is physicians we've with, a a And to the being what saw example, a execute. a see the to XXX traveling and our because to very get another way, XX, region of to these of sort we said we physical events are to open had that of from by that done, other they meeting. for with comfortable now, event, effort group meetings speakers tour XX, are go German XX, they up this to those who more driving, Instead that are not

we a terms to picture the couple the able and over of uptake lot are adopters. The the early see range question So okay? adopter Roanna. many Thank how German of the target will strides. better quantitative see just also in is to quarters, of the single it effort, in again, we next your important scripts a believe to back And digit of revenue. about early audience, that, way, Going you, be but of in

Roanna Ruiz

that U.S. you and And U.S. the adapt maybe really might strategy your inform then gaining new strategy curious. That's gears internally What a quarters? how switching I on to how how go-to-market great. pulls to the next understand quick is Okay, And was traction? the helpful. tracking in metrics your are push you

Karim Mikhail

questions. great Sure,

we is are know So really to on we're stage. critical what ones the metrics at that focusing the this relate

said know physician the engagement we target that we we of field did don't able of was the We you've force, level, with to difficult but and door incredibly open. the not have the drive the that that audience. you despite growth As them a depth it not to heard, is breadth the and the with engage at if because limitations large access because were have

a So our reps to we're closed, did is level engage, the territories that on not a sales our that what to are of doors engagement was number knocking So we of to spend right? where deliver. day meaning going their important very redefine metric and able can they're managers actually

Our and move able discuss needle. meet, team is the to

are prescription of the prescriptions So of the we now, reach opportunity believe XX% we we to many we and in also there but how and drive are and the That's expand VASCEPA higher, is meaning physicians. prescribers average broaden driven able even X,XXX engagements the by of this only breadth can on to U.S. depth, delivered that Up number by that have to the deeper scripts number engagement the an that why be drive.

one So that's metric to relating engagement.

clear. with with The obviously significant risk second who the generics today number what we a which for getting because cardiovascular situation that is do are are indicated approved still indication, not the the continue our generic, control, and things the that for one indication has we patients is there seeing market an of beyond do very is to the of that are are to being Amarin things If generic. let's And as I'm can face -- what it. there the are generics are out needed about supply this

more X% use the have continue What legal not own of if but the of There That's supply, deal to to our what prescription. what needed we because payers fulfillment is control. push to sort path in a is market, have doing size in our is are our control to with this. indication of Beyond the X% secure is we it the they that is and they literally will challenges.

number what the Are getting? is a level rate. we the the day, So of have be really focusing as that many And the fulfillment truly by prescription How end written metric to is fulfilled a why at at are higher. on rejections fulfillment of what at a we're initiatives is day? the end the physician, of pharmacist we getting, every drive this of to much we that's

I hope it's Roanna, the So are question, on. focusing a difficult clarify. these -- really we're I metrics but I

Roanna Ruiz

that was helpful. Yes,

Operator

question from next The Yee coming Michael Jefferies. is from

Michael Yee

gave aware I is specifics: there you these had Two initiated good in -- urgent the that? those is some things were question just types how rare force, slide any thought And any there. around remind on-label be development One sales Can remind think interesting of you really of enforce prescription you there. may, just lawsuits Can an was quite trying I traction important I where cardiometabolic prior some your there's back, you those really just be me I comment mentioned questions, of some second And that pharmacies, proceedings diseases. near dispension. on if pretty on think would potential And interesting. your leverage development important. had to term be? so could to I is could maybe be just or that go I'm there about products how if specialty business because or in I think could whether think that, part talk on if mentioned obesity, the against briefly that you then management of me update out so that quick. were, future,

Karim Mikhail

Thank Perfect. Mike. you,

the this this dismiss [indiscernible]. place. more, the it's There issue. if deny against fight on also to was in our is denied, asked continue have lawsuits, or time by And an We we to on point a a request the We at actually and request strong of case, continue took have pursue. X the dismissal, judge was because for we any This expecting There decision accepted, in accepting of and we what do on chain. a request if or that very we're then pharmacy will a generic in certain pharmacy actual we terms dismissal case. weeks. what continue So the ago one judge two and rejecting real believe the against hearing. any bit we will to few magistrate that for in any for a the a it's or place weeks them appeal standing have a supplier we this. with position to from payer, This In a district basically actually process That's not have let's clarify. we specifically, opinion next

question. the on first that's that -- okay. So Is

Michael Yee

Yes, very helpful that part. Great. on

Karim Mikhail

Yes.

building diversification. to color almost time lines will to These way engaged that spread no of We're anyway. clear This somehow so obesity the from regards targeting. mode an on at? VASCEPA wanted go have them earnings more we we're question call of on? and looking on very thin the with saying thought we're we qualify be we highlight leaders, get the and or What VAZKEPA. intended some the second any We focused because and and you believe that And even are areas was we're because launching type in the the in are space. the in authorities the equity I building effort building the urgency to that's launching think add that we question, to On credibility. to to ourselves us incredible intent So we therapy cardiometabolic wanted in leaders, regularly. what focus under making What that U.S., are equity, We're scientific it still you while are this we're launch all right? take VASCEPA away cardiometabolic, we're with today. I'm not

is and believe primary then of about care area, it say we're that sphere so diseases, focus in very in open talent only we asset focus "Oh, It believe assets thought allow nimble to Now associations different go-to-market more our to leadership, evolve us adapt model, the the scientific the way, primary we because specialty And dramatically. cannot on we assets," we're but rare we're will large-population types if but clear or and style, say, or that, we experience can whether because space. let's less the are we care, have this by because very limits we the same. our

to Mike. So I with hope this [indiscernible]. was sufficient, that's regards

Operator

next from Cantor. coming from Chen is The Louise question

Louise Chen

stabilization on color you talk just how you sales is there. about little a bit here. So I to Maybe you you know plan more confidence. for U.S. I of do in then first talked question a there's might fourth when how more you about think we bit the us, if should operating that. you that elaborate about could of sort And 'XX? that about see had bit the on get what think you talked lumpiness. anything little you gives a quarter then expenses a give in I you And know little timing,

or is help there Outside global the you China have us and the world, at where look maybe peak So opportunity, here that so would Hong areas sales to? think thing Kong could if strokes, opportunity. look broad $X you just other last billion, great. also And that at us be you as then of just could give you and of global the you when do some get

Karim Mikhail

Great. Louise. Thank you,

U.S. the that the a the respond sales. seen. the our so I announcement like on or it's out to change ago first, came to So about month in that go-to-market challenges we've mean strategy,

that are conscious very execution changes. we're time, but in that we with why place, So growth our the the not that's are want. taking that this also point And with at made dynamics we we delivering

temporarily. a disruption, comes right, change bit of with Now

this XX% that, qualified. audience, group said first in target need okay, a there on our going strongly where period lead -- we're to I are new Having that continuum. be on this nonbelievers? do? their they say, right? the understand before, page. right growth. is they Let's be relationship, they we What that making field mean to very physicians the the believe This the do So they need the of met month that is for not is They're to prescribing incredibly they working to where believers? have We they Are today many Are to now them, team. a they're effort This have new of a to people that are this meeting this will a next real. new are in be need foundational change have people phase that XXX to going they establish those era.

we Let's how far go go. can and see

a strategy So but at will new aggressively us to and get very the quarters we anchor ourselves are group. it take starting because all of go-to-market a this engage one that of basically we the same operate, with was early press digital broader time, part omnichannel couple that and to immediately from strategy weeks as could simply as on far button the the

the them, this we say And over to this go-to-market will we we some, but to So quarters, few to strategy next take every hope, track is making we know certain looking ourselves the effort the of get get elements earlier will to exactly said, have this, not "We for, look we're We and we're as will time know not the will really that results advance are in of results. If we market. then mirror realities the We're we at make to looking the trajectory." reevaluate. changes don't make. these what we and change growth accepting

address So that's making on that. sure the U.S. growth we and

to important so investments we've that that we're as of next needed beyond obviously have we financed, much In to believe because top can. I'm operating expect we of you've our generating dedicate did the long and all what the know of a expense, over operating in right Europe And now, as us we're level seen this that in quarter, still simply last in that most activity know do expenses, We have few and Mike, revenue So part is did level terms much trying we of more terms we launches see investment very QX, that something? effort being sure for quarters. that, but we're of on we we the we going right? drive in add well up journey. to measured higher cash you to expenses the to growth been the in a the we want

Michael Kalb

it funds continues to I'm just and going profitable that be U.S. further to growth. say

Karim Mikhail

Yes. Great.

you the billion $X opportunity of of in than Out region. see XX. the China. have Africa statins, to I look not we time, a point X, statins more $X up we to the X there business East, this that Middle there: And important most and so are on the did is the we those Canada At at, those in those there sales. in that if is mean, global China, what that you've the and potential seen Now China, markets size in opportunity XX definitely of going say billion counting we additional really between

there are in So quantify over to the this is we'll another already, as -- process very usually And the you, to let's it significant see approvals phase we going of questions with to Thank so you XXth I'm process hour, of we support know, stage, is get we're opportunity. we them not huge you definitely stand the Louise. with at silence, a silence, we're regulatory evolve Edding sort in because there the continue regulatory opportunity at is to how authorities, to that then but time. the with work very, where sure there. you but regulatory that today, And have get but And address. silence. Chinese many intensely, ready interacting

Operator

from [Operator Sachs. Instructions]. coming And the Goldman Choi next Paul question from is

Paul Choi

of here sequential to as XXXX? I price realized about trend just just from comment here you share and been and in potentially see here. want maybe being net growing maybe has dynamics the pricing ask the how think impacted you impact and on just market what Can that in to gross net-net about terms generics you

Karim Mikhail

Paul. Thanks, Yes.

going a plans for that generics, net It's ensure I right? be so are to with been nonrelated certain but in than level national prescription. really, that eliminate that effort the any impacted what barriers see many price has overall seen are to think net, to generics the opportunistic communicated gross that I This to changing X%. making. exist the is think, twice not less our to we quarters, related a the is we dramatically. And that we've way, at On We an that far even we but average we over maybe

this question sure the it's -- of us barriers. see what competing not but don't It's believe simply right? a with be regularly at anything unusual look will a that would it stage. I at we trends as slight potential a there beyond market, be we I and would those decrease something product in negotiations net So price, making in doing in that discussions expected very because the not any and need remove very, don't we

Paul Choi

distribution update countries Okay. you you in would you then regard finalized? as here, And potential be the for could can contracting the That's just us in be Karim. And when near-term on a potentially where on follow-up with those to of geographies? which color, think that you just have do filed partner maybe position and maybe a and helpful very are a with arrangement, identifying dossiers to you the status

Karim Mikhail

Thanks, Paul.

on So question of partnerships. the

the So to you we Central that a is and number because of already receive engage need Europe, process countries. initiated request. started Eastern time we the process with for this takes Obviously to a

You need to do your diligence.

You Are need requests be going to them. do receiving you and country-by-country with. to you're compare you it really request? a and qualify regional all contrast the better type regional? So until better? is between have receiving which Is work of versus country to to actually you Are partners by requests? able to country a What you wait deal receive

ongoing So Central for Europe. Eastern is this

XX additional We of them. process started. have level. process those Many have their that lines long these that approval have only so of for we we started but -- We for process X delay to process based going very in can simply we countries on has initiated believe of not international are that the that not countries, this we an countries the That time are yet regulatory we XXXX. not and submission regulatory the we pursuing approval, because mentioned some too achieve on

have partners will we that, achieve ready in will we because countries. these So need to

in XXXX. we very So initiate to early this the process year plan

Operator

Fye is JPMorgan. And Jessica question the from coming from next

Jessica Fye

the break specifically -- and this. third forgive you in me Can revenues quarter? What European if were missed out I

Karim Mikhail

little there revenues think just in very, Off very in bit very of the many $XXX,XXX. clarify I my like I that top so -- works I yes, or but maybe quarter. was the something revenue. it mind, $XXX,XXX, it $XXX,XXX these there little of countries. will reported little them, were we third believe a was how

public wholesaler Price you is your on became sign cannot your and X. public, you imagine. to all, them of until September first for only just contracts price So

clock to engage when that's want wholesalers, So with if you starts. the

going product contracts. to not some to we on rush September the with system, actually update sure be these X electronic orders, because are supply. and you is pharmacies to sign because, So a the listed Make month going are but really to month prescribing they wholesale your of was The put October quarter X to that filled prior of to that decided German the system delay until prescribing quarter. request every submit have not electronic that system their some

So price public. cannot the is you price day before because we submit your submitted of the

be day sequenced you they many the fill new electronic when almost system, September key Having of any the October physicians very to all by see we to prescribing X in even the not have in and become allow pipeline to by the So you're up a that, the ensure wholesalers this prescribing to us until that still pharmacists. electronic price are on X. to from listed system said was requests going

So the have we first this We many medical -- teams of in country. educating. had in was we're And countries, other process shortest takes the time, mode of I that our will will we that Germany, In right? especially remind prelaunch have the period today, prelaunch.

other some the medical our You Spanish events, with you'll see -- lot of a media of that on team stuff, is teams in Nordics. see working the social

unfortunately, this that didn't So we in effort, luxury Germany. have

because of this up are time. all now of catching with the limited We

the for So clarifying launch. that's data first really points within and revenue expectations revenue very German the

Operator

any to like the remarks. other were management back this the call questions for closing at time. hand queue Amarin Thank no would in I you. There team to

Karim Mikhail

Great.

questions. we XXXX. next the So to for again your you We're you participation, all happy Thank you connect able thank all earnings at you. look so And Thank with call we were contribution. to forward much. your that in address

Operator

ladies and This conclude you, does gentlemen. Thank conference call. today's

your may participation. your you and this day. wonderful Thank lines time, You at for a disconnect have

Amarin (AMRN) 3 Nov 212021 Q3 Earnings call transcript