AMRN - Earnings call transcript Q3 2018

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to Amarin Corporation's conference call to discuss its Third Quarter 2018 Financial and Operating Results. This conference is being recorded today, November 1, 2018. I would now like to turn the conference over to Elisabeth Schwartz, Senior Director of Investor Relations for Amarin.

Elisabeth Schwartz

Thank you all for joining us today. 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. and include, our not including margin, commercial Vascepa Vascepa statements current to, levels expenditures such and prescriptions, regarding costs of expectations and product resources. and of the but metrics, our limited are our of other adequacy Examples commercial revenues, financial gross licensing financial performance,

our expansion, expanded a thereof, that reduces may us our Vascepa for studies, the We results Our Actual current and to current publications and presentations, results patient expectations scientific plans paradigm timing regulatory The our reviews the of our Mochida, our meet in materially. and statements in are promotion Vascepa, information and lead related regarding statements. forward-looking XXXX. or our the based commercial These goals, our the expectations our to plan plans the potential, potential new on agreement for events collaboration expectations current expectations expansion. X, scope market including today, for and effect could or plans on co-promotion our purchase our to of treatment development of of not or business. differ regarding salesforce and related positioning additional other and intentions, supply international November timing out disclosed available preparation for carry achieve actually could further goals with population

We to assume So you obligation statements. circumstances undue should no these place these on statements not update reliance as change.

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

see is amarincorp.com. filed differ Statement our Relations have Quarterly call These providing of We approved morning's could Vascepa the to and SEC in to Amarin that are also not accompany promote results XX-Q of our the This its documents. investors press indication. the be website in Report Risk section updates additional this XX, key intended that today's intended available Please of factors These materially, with the at we Investor on to the quarter slides Investor website section concerning Events under cause to read Form on been found for can for ended call. these slides, the note section call. in of and use today's and September release outside which the For through our documents is sub Forward-Looking Factors XXXX. actual summarize amarincorp.com, are on the section encourage information everyone some Relations the the and Presentations category please discussed

Finally, call the this the and Amarin Executive be an of over I in Investor the also, section. Amarin. of Officer posted Thero, will archive Relations Chief to website, on now John will call President turn

John Thero

have morning. Good many Amarin the for of and It's steps American results that the REDUCE-IT about appreciate Heart the we of study. take We at of scientific the exciting XXth details investors towards as at more busy expanded and professionals Association. inquired promotion REDUCE-IT prepare presentation time on an healthcare of November and study sessions XXXX of Vascepa detailed

on We further at details of is November we have Heart Association their which landmark these promised results for that will save Medical regarding AHA, American reporting presentation Congress XXth.

of announcement remains Sessions. we additional that September our Scientific forward That at repeatedly on look Following top-line stated AHA of have we true. the XXth, results details presentation to

clinical REDUCE-IT Principal Central plans lineup for Investigator X:XX breaking part be REDUCE-IT AHA present AHA's PM detail is the for to not will announcing more Hospital. Time on presentation results. the call November study of of of We Brigham XXth. The REDUCE-IT Dr. Women's Saturday Bhatt in scheduled on as further Deepak lead today. this of at results results The trial

press the related and AHA, with a the release at timing provided presentations We regarding XXth. release we including investor and issued presentation conference Saturday access for November call an information Friday, press and REDUCE-IT last In call. for conference will Amarin's scheduled around we follow AHA information

During investors we at to day. that that results that AHA REDUCE-IT will as presented analysts We hope and review earlier call. intend call, join that

The whether those late the results study accepts breaking Omega the of fact outcome you results via results or Vascepa tape in ASCEND [indiscernible] positive. negative at recording VITAL seen are results Lovaza presentation established the achieve earlier in it, in the of as many knowing contrast to in that Vascepa. study Omega We distinct follow of announced. prior the is endpoint. will study. of is and to trial the of presentation failed products the mixture of and that results VITAL to Lovaza. shows of scheduled the results generation studies results were occur If to to remind the AHA In clinical are not ASCEND with REDUCE-IT of and evidence of clinical AHA primary miss will Amarin August you website. ASCEND and VITAL of unique REDUCE-IT you recall trials. from The the of be VITAL the in study trials Europe another add are study an X a Lovaza the may failed of the prescription presentation X the immediately the study regardless body is study. The available of Vascepa that made to Amarin's of results cardiovascular XXXX, of presentation mixtures outcome its effects stands

anywhere between top-line, mixtures. the therapy. body demonstrated mixtures say to shows top would medical the the we reduction Vascepa However, we Vascepa surprises Lovaza study failed cardiovascular studies outcome because in if Omega-X surprising near VITAL of or It for that of level lower confidence, protective the study vital in and no contrast anticipate cardio cardiovascular other of has XX% to Omega-X community statin drug support of the other evidence approached the by this from results outcomes some XX% benefit. Even very results. ability on approximate results be further reported if REDUCE-IT risk We with will events and differentiation

data follows. regarding clinical While already in active recap want they don't the the Vascepa, to to of approximate XX% take cholesterol results hopefully XX% cardiovascular though adverse therapy the study occurrence REDUCE-IT different people delve REDUCE-IT is and results, MACE. line cholesterol was in lower with for LDL reported considerable study effects statin controlled of the contrasting mechanistic there of the REDUCE-IT of the-top populations to to if top all of by time data known A effects appreciate ingredient as by understand is statin the the The different LDL into other results will controlled against underlying risk composite unique VITAL published patients. the XX%. major endpoint science. on we and first Primary as therapy cardiovascular by of in risk reduction help achieved relative events XX% is generally understood

Our across of than top-line REDUCE-IT results XX% multiple add demonstrations endpoint high controlled on secondary to approximately was approximately X.XXX. robust of The XX% results supported significance a risk reduction cardiovascular reduction top This degree efficacy achieved LDL-C. top-line less P of by primary were endpoints. statistical risk of

information presentation regarding more at not secondary until the AHA. will be We endpoint providing results the

statin labeling. for side, with than well on other fatty shown safety Achieving top safety risk of is Omega-X therapy. Vascepa has consistent therapy reduction profile tolerated current a XX% acids been with was more the FDA-approved any On in

incremental be the Cholesterol unmet with to lower XX% United clinical For positions reduction leaving internationally. XX% XX% substantial we to to risk. of new XX% cardioprotecive may risk that risk cardiovascular help management Vascepa. by Vascepa to patients and We example, risk risk provide and XX%. benefits of is to or is in therapy. used It new cardiovascular the a in that widely lowers is TCSKXs care lead results most large the Vascepa a cholesterol also paradigm from benefits position risk believe Lipitor reduction to of seek Note potentially beyond management. a Vascepa medical layer address residual which patient States They Vascepa's results need. in millions atorvastatin the statin, XX% first-to-market the residual position to statin the Moreover, of cardiovascular these addressing approximately REDUCE-IT XX%,

deciliter was triglyceride per at a medium mgs study. the was were the high. baseline lowering excessively per Recall with start levels. were levels LDL of triglyceride REDUCE-IT achieved Baseline JELIS from of cholesterol reduction that controlled in the study at not Mgs a it As deciliter outcome was study, X% risk lipid-focus cardiovascular of XXX reminder, levels well a XX a the XX% not only and study,

ingredient in While shown in clinical has risks, cardiovascular are are triglyceride of significantly recent the unique. reduces established been levels higher alone have associated the levels that elevated effects of not active triglyceride that lower cardiovascular risk. Publications with levels years Vascepa it

this endothelial function, various active formation, including to Data triglyceride stress, addition and modification. beneficial lipoprotein progression, of formation processes thrombus and platelet biomarkers. that ingredient In have independent may on and effect rupture lipid inflammation, improving plaque levels formation, aggregation, of multiple suggests cell all cytokines, [indiscernible] plaque foam Oxidative

be oil are any that changing were our such will to generalized DHA. our REDUCE-IT that the fish results. following In achieved to higher I cannot actions can common to expand promotions the and QX recent or generalize results that statin the acid CFO first results generation reinforce Amarin's those discuss We to Kaib results be our financial REDUCE-IT short to review continue Vascepa Mike particularly mixture to unique while products financial Omega-X paradigm REDUCE-IT Omega-X success. will add-on as a results. Such prior cannot and contain finofibrase REDUCE-IT Vascepa

year With company study per this the know, been size in the over large REDUCE-IT majority like you we study. a behind per research with As follow we XX a or a of undertaking publications posters major we years was have or spending and has $XX to scientific on supported Amarin. pursued Amarin The This approximately any because recent million for in year. associated believe it undertaking and Vascepa more scientific science spending been significant development. has respect We data. particularly scientific company for of and small science,

science the to not to proud ability advisors expressing with surprising Amarin's to improve quality flattering involved hear high is REDUCE-IT team. are regarding trial is but of scientific and care. dieted Company that patient which We outside be by to driven a the It are accolades and repeatedly the

resources, been R&D team. because We investment Amarin's limited. the by team are lot has been limited of the commercial large on a in have necessity REDUCE-IT also commercial our spending results of to productive. years commercial prior Amarin's Nonetheless, very in has proud accomplished They

Care achieved generic have comparable with Lovaza. approval the Managed approval broad We coverage is which rates to prescription above XX%, Vascepa rates for for

indication based achieving by marketing growing approximately revenues been despite those considered not $XX very good. the for its approval not per a until niche have Vascepa do XX% biomarker despite size recently. Vascepa approvals Salesforce is closely, drug million and follow our For rates who year Amarin increasing significant Moreover,

believes Our about relationships their commercial before expansion study, and team in are help effectiveness levels of created team to and REDUCE-IT in activities. Foolishly experiences. promotion. consumer improving of added they After our for data our during we study these care. capacity, with XXXX, supply healthcare Vascepa and expand and recruit of renew results we of to outcomes have patient passionate began Vascepa should on good actions results the planned scope REDUCE-IT size sales further promotion, build Having build personnel, should inventory, plan as commercial the the further who the evaluate and professionals

This in potential on-track billion topic expand with support should revenue we not reference supply, to be guidance. remain the of capacity On XXXX. confused $X in revenue to

position better we help Vascepa the better We continued transform affordable and professionals the believe existing dollar prior express revenue is intend into REDUCE-IT this results wait coverage the pricing commercial results results becoming help guidance. a to REDUCE-IT at brand. before the steps for REDUCE-IT provide appreciate Care appreciate While to of we success. Managed multibillion healthcare we made Rather, and bullish until that Vascepa will of study reference do took to us

ensure further REDUCE-IT we that be supply that increase that our dialogue to we certain with capacity. supply to supply with as might Following success, have chain companies well our can as active added been companies in in our chain

expect, to opportunity other eager might are to do you companies this these competing so. with As and each pursue

we and meet We confidence will skills be able Vascepa that to in team’s execution we have our supply and experienced growing demand. believe

created Their phases. focus new Vascepa. small which recently realigned be we will and will Vascepa Our our team promote of management. territories education to and expanded This to are the when XXXX. end label anticipate will occur to sales before risk clinicians. Vascepa sales beyond select the we of our been broadened promote cardiovascular in education Currently, REDUCE-IT REDUCE-IT cholesterol our reflect XXXX published, promotion continues unmet specialty ability targets results expand Vascepa anticipate have with remind results, of before clinicians The which sales of expanded significant expanded team is end the the of when to the of

our One our training Nearly XXXX. U.S. to sales new are start being are start current Sales to These be top now our priorities of expanding with new hires representatives slotted dates salesforce management positions approximately year-end. before are is all sales XXX QX. hired for completed filled. being throughout to of courses representatives

education many so While have historic from physicians broaden we target who more supported than levels. believe that could been programs. promotional prior results and a multiple the to benefit market doing target will XX,XXX patients Vascepa. doubling physicians will They in have by we our on of sales be calling representing The REDUCE-IT team

hearing publication results. the already requests for of physicians REDUCE-IT are We from

request independently curriculum REDUCE-IT Our that, Vascepa. the Similarly, even independently they only to November opinion managed for patients are know programs leaders, is address provided time, help key fulfilled medical to two small team a grants look team at be education study until from are highly the intentionally forward receiving help managed is for to results affairs results such Such presented at questions with AHA. of motivated REDUCE-IT of medical number their Amarin. results this cannot REDUCE-IT which We opinion the programs At helping our is sales physicians The key unrestricted at leader XXth questions after people presented education AHA. of AHA. results. on

and REDUCE-IT we on paradigm anticipate combating education. statin this risk potentially XX% We remain optimistic medical is in the QX to as management for Although after adults XX% risk that treatment at cardiovascular as beyond. treatment. various topic for anticipate of to of supporting market for they will a medical additional be focus that programs are a cannot results unmet cholesterol The new priority that need will by We addressed address education tens REDUCE-IT offshore millions the large remains is large residual and in alone. that

and proven please Vascepa's opportunity that improved it's volume Vascepa well a is a coverage, was more affordable Amarin's price with that statin are We foundation patient option years financial care. As to pricing previously in and grow broad a ago much therapy are believe opportunity. our that believe existing creating we of Care stated, XX scientific help new than strong where believe Vascepa We that with significantly review of positioned we Vascepa with it's for we results, results. the Managed today millions KOL support and Mike, patients. QX treatment

Michael Kalb

Thanks John.

quarter the third REDUCE-IT such XXXX of As product period our in in operative not strict John continued of in reported XXXX. that results for QX, since expansion XXXX growth quarter the corresponding our or earlier call, Nonetheless, revenue from over the benefit we financial reflect a results the following efforts and did mentioned commercial of results.

of Our in XXXX. amount $X.X was or QX, million the QX, we XXXX million $XX reported net XX% product above revenue

the Our an amount nine XXXX of net $XX.X was increase reported the million XX, for ended above for product September or last months period million we same revenue the of year. XX% $XXX.X

provided productivity X% on by total over Vascepa and XXX,XXX over XX% year. QX net supply and this was QX XX% months continued XXXX and total product normalized primarily and XXX,XXX calculates XX, an Solutions by Vascepa rising IQVIA, IQVIA respectively Based Symphony by driven commercial led data of XXXX. increase Our X% quarter This estimated second our prescriptions respectively team. as XX,XXX in and by growth during increased the associated days XX improvements normalized approximately Health by both revenue three prescriptions to respectively of ended provided the QX, by over and respectively, XXXX XX,XXX approximately and to September Symphony in

time this at any balance XXXX not beyond. product Amarin for previously, quantified stated revenues the guidance As is of providing or regarding

of meaningfully once understood. the we increase While Vascepa will from that are the results study or REDUCE-IT demand optimistic

Before REDUCE-IT guidance, and presented, physicians need understood. after from we results can published are feedback provide reliable we

the As size sales John are stated, we increasing team. our of

of fully in will the will clinicians. published We of able study expect at this anticipate we the with expanded results the start be trained field the by be that REDUCE-IT then to share the be to team We publication XXXX. and

Lebanon anticipating to historically XX, sales, months were for licensing the good nine year Commercialization XXXX. million September revenue and impacting Vascepa outside its While for our the and of Vascepa with a $X.X results publish. this at in for recognized fees of including commenced Company revenue by intended the has approval Vascepa pursuit Vascepa for Such are in China ended to have by QX our a being been related stages States. United we other partner for revenues a Vascepa commercialization and U.S. milestones the therapeutics. performed of received United timing under our ongoing by HLS upward further Arab of quarter and expanded REDUCE-IT the funded Licensing other impact with until work recognition the are Eddingpharm and of international in is partner not of Emirates factors significant is in results agreements the the AHA early outside expansion salesforce clinical trial presented

We global for to other opportunities will market continue Vascepa. evaluate

gross the million [telco] on profit for accrual following This million commercial XXXX product activities months ended fees product Selling nine respectively, promotion an fees and XXXX $XX.X of spend months XXXX the was being due XXXX were including by fee. of first and through program months XXXX. of scheduled payments million increased included $XX.X in resulting general Are million payments. anticipated which XX%. in XXXX Amarin or tail expense of nine XX, ended historically to on revenue, the agreement salesforce. increase generally to expansion $XX.X and $XXX.X position sales year as increase support $XX.X co-commercial respectively. The funding Total reach including a for margin (Ph) of an calculated September were frequency a successful XXXX been is were mostly a the net and XXst percentage which co-promotion co-promotion XX% to sales has in means the XXXX for in September of by from for this Vascepa December professionals Amarin's REDUCE-IT for commenced and a gross and Amarin's end and calculated has low having Our administrative This XXXX tail higher XX, presented the was increased a including intended primarily promotion XX%, freeing nine for of pilot albeit net co-promotion This consumer relationships results beyond co-promotion to accrual increased payable promotional co-promotion up on including XXXX second million. and on small salesforce healthcare basis. expense arrangement,

or currently Amarin co-promotion and of costs Company's timing has an effective Amarin XX, and to Pharmaceutical increase announced cost will $X.X agreement. million REDUCE-IT due with upfront to consider and million the months increase extended an payment While always development increase previously collaboration related $XX million million Research limited. incurred mainly This productivity, to related expense $XX.X of for respectively Company the XXXX strategic $X.X were not sales XX%. is and ways Mochida of nine September as this cost XXXX ended

the study. study decline and of pursuant initial closeout to will publication this We of on continue important our RND completion activities REDUCE-IT from of to soon that spending results anticipate level

More million offering expansion the reported and receivables same option late quarter excluding net cash from preparation were is months September for the excluding million. previously Market settlement and $XX timing expansion the our payouts, associated made collected results was of XXXX, REDUCE-IT nine October. of outflows proceeds this made XXXX, levels $XX.X XX, excluding receivable payment was related institutions with development made million related and preparation cash XXXX equity first flows awareness positive cost finance preparation of positive from to the first stock the which flow the months in million other REDUCE-IT resulting Inc. in ended of primarily September from excluding related REDUCE-IT relates to million, net interest increased U.S.A. positive expansion completed September cash research exercises Net REDUCE-IT and intended expenses to $XX.X results inventory. proceeds specifically in negative accounts excluding payments for with excluding various onetime net flows $XX.X Net financial which Vascepa financing other with upon nine and year in million of from include agreement royalty, XX, rapid the period Teva cash in Amarin in equivalents positive early Pharmaceuticals announced the in costs in positive for amounts cash REDUCE-IT. of most $XX.X $XX.X As payments results. which initiatives to for was and of cash for and in support study Payments

to for positive excluding While a cash REDUCE-IT aggregate, in financing in we Amarin story of positive the out flow understand importance of cash getting purposes flow, of we point perspective.

$XXX.X is September December company of due XXXX expenses accrued any Pursuant of which remaining obligations date effect obligation October a obligation revenues XXXX debt of from fees XX, the satisfied. co-promotion debt. until of obligation $XX.X have November $X the primarily nor associated payments. maturity on debt rate the tomorrow, no payable million we the at Company's royalty and million supplier timing The longer the of exchange interest like and had aggregate at with paid to XXXX of the with XX, be to is a XX, announced fixed in will Vascepa Xnd, accounts rebates, $XX.X increased remains to bad million annual million As XX%

outstanding $X.XX. does in A and preferred include issued shares approximate at million of of underlying Shares million As ADSs options stock ADSs the equivalence X.X and approximately outstanding notes. equivalent convertible shares price approximately which not shares of share million for exchange of million exercise $XX $XX September common a Depository weighted XX.X Series million XXXX, Amarin the XX, had XXX.X or American ordinary average

$X.X stock shares million equivalent unites. as deferred or restricted well underlying As

for net stock loss adjusted third based compensation, gains and net $X.X remarks. million $X.XX. share John? $XX.X turn loss loss per adjusted to I the and John the basic non-GAAP share adjusted or over call basic third to of per XXXX back of or or non-GAAP non-GAAP Excluding will quarter million XXXX non-GAAP closing was diluted Compared now of for $X.XX. diluted losses loss adjusted of for quarter for noncash of the

John Thero

Thank you, Mike.

For we on you forward this interest you speaking who parallel, look we Amarin. educate In respect all XXth professionals assured building please reporting broad call, of AHA. appreciate are scientific strong We November with steps to again foundation at the be commercial our that patients. to on in your help on are with results of about to towards taking and and healthcare more to Vascepa REDUCE-IT

touched my AHA. the we comments, REDUCE-IT opening at of to As eagerly presentation forward from results look on

insight to questions. will comments. would our our we in seek to on prepared any September conclude that the that, questions we not With beyond respond on some REDUCE-IT XXth. We which we additional to press Operator? like However, open substance data who provided in line release

Operator

Thank question. you. question Louise first Cantor with Please with your Our Chen [Operator Instructions] of the line Fitzgerald. proceed comes from

Louise Chen

taking questions two here. Hi, thanks for my

Vascepa some I it compares I give color to for gave color you the that else U.S. of already size you. question expand? if earlier opportunity could, anything call. Vascepa? first us respect when in might the are could and great? Thank and the that with the steps you you I question So IP and be would know second had you you is more we the us of know the timing OUS of trials let had the questions get on And are How next was for what pursuing lot a there, on

John Thero

one I Kennedy Thanks Counsel pick side and have of the IP it's had Louise on will the talk our General good for will Joe about morning we there. recent the activity questions. some the and first John. things

the unfortunately So have large throughout potential we worldwide is a phenomenon cardiovascular disease, world. heart think disease I opportunities and

terrific have in where are conducting trial got they and for We a funding Vascepa. clinical partners China

dosing interest where about have in we had ago approval until we a that previously Europe in to a by on have whether already the consider ASCEND there authorities which The funded long failed East a opportunities an it's Europe, we was upon We our going result earlier a markets we approval expressions partner other different pursuing Canada. go by a study and Europe two gotten by in I we to therapy questioning is for is opportunity as different and labeling, as that company REDUCE-IT had giving study the priority area felt Middle and continue have and course Europe Europe generation - introduced way to failed are Lovaza to to in opportunities. of should though example partner in be that that an where [indiscernible] something having countries pursuing markets was waiting opportunity And data and in and different some pan-European We for for that the had is marketed reimbursement. as the Vascepa understanding for that based we of in a signed in giving provide results Lovaza, following as be aside we got which talked outcomes it from each [indiscernible] the would the those potential as Institute. there other greatest has is of Heart U.S. opportunity. British not will of approved will country different mention regulatory up as

U.S. its bit where the we is presence a large the on being is said global internationally. it's have market a that dynamic a market But So landscape opportunity largest direct there. there a going of

at to submitted then on additional in Right of results the the AHA adding priority early We to now third-parties XXXX are looking NDA get we our in here top clinic approval partners. presented relying getting be partner states. so far will the is getting the published and and part forward

Joe with helpful. So as those regards Kennedy questions. related IP comments hope are a

Joseph Kennedy

emerged for question. the second these cover Louise the one by won the in favorably picture big there We in claims focused judge a of are for applications, which specialists, the on from mostly reviewed And investors of with the was And forth settlement office definition of the they been the of went patent than and supervisors Teva exception that of was not back the were enter then them patents course where which Wall patent prosecution and reminder, half examiner, while prosecutions And we of an the because of we think group reaching then the the terms have the It less examiner inventive supervisor, a well has ruling litigation by determined of very of dubbed, both is assurance after of with high what all only end matter the Thanks the our advocacy the where to construction us. but have to by with with allows special was patent a additional us we XXXX. just application sides. throughout of Reminded assurance X.XX% Sure. at part quality significance. elite of by a have when by of with of who back that litigation. is expected office in the without August which marketing large and Street the claims patents raising for the we warning we this goes and lot agreement the LDL. have quality do reviewed those and from that patents are profile of we of the The in use and nature we the they the system are remember ruling that on And reviewers patents got triglycerides just treating claim is subject that nature results specialist XXXX the application. and on on two litigants. very trades year with a of that, those at was no there patents high are for lowering ascribed with most method in XXXX

we we a as the second discovery right half are so in XXXX. fact that to cut this look where in now And we trial forward off. haven't even we litigation, the of And expect finished is

that. invention generics all the point are at are knowing at we the going about So through where invention and still

the stages in again early having relatively And that so mark. had, we are favorable somewhat still

seen significant that half year. So really we is feel second pretty and until outside this of is next really going be the the nothing good there from of to about

Louise Chen

Thank you.

Operator

Thank you.

question Beatty next of question. comes Joel with Our Please Citi. proceed line with in your

Joel Beatty

initial Amarin Vascepa of your REDUCE-IT Hi, the to that their physicians in some could able also position results detailed of marketing information top-line about information thanks physicians then from of a are being more unique forward taking the information with share - thoughts uses REDUCE-IT? And I presentation? from Thanks. so of about believe them team some discuss feedback sharing question. a to data looking you what on for physicians, is with

John Thero

Joel. morning, Good Thanks question. for the

most So are REDUCE-IT not physicians with result. the yet familiar

we relatively As expanding are small of communication we a have results, relatively and rapidly size some can have a while data presented size REDUCE-IT but yet the salesforce, that, reminder, isn't we small or salesforce the published.

there is this there that at limited time. we details can share out So in point

Vascepa is is to the high a that results seem million it and prescribed and We as familiar them are have and want is to degree insurance expressed to affordably many product has learn physicians these they covered times. from details they learn physicians broadly are and of with more the hearing that for four priced who surprised interest, of they by top-line over new

look So hearing not like and I presentation to more away been it's point. far. this so that is AHA and encouraging forward at think far They us feedback probably you

Joel Beatty

you support availability follow-up can what do from Okay. have the And I Could and to you the other of of question. over EPA help counter Vascepa? the discuss use providers

John Thero

are counter, - a and over if dietary probably you is supplements, of kind previously and drug something then to the which mean say So, really that was the was referring the are no over you I when status. given calendar which overall you over - think counter

So, to relative dietary supplements.

a folks it’s First and they is these product. prepared, very become just failed content it's it's known that we other results dietary you mixtures the products. help of of results science and oxidation between other supplements all degradation. divide also or particularly foremost, between not I how the but its the how It's And a fragile the it's it's lot of molecule. remind prevent how would that EA when There stabilized, Lovaza Vascepa of think of the light to studies people and in REDUCE-IT including the other will the highlight effectiveness the study

litigation Beyond that, through ways will recent I that we let are in our Joe but taking on. comment also ITC various matter, action some through General Kennedy the Counsel

Joseph Kennedy

Sure.

small drug entry have seeing Those brief lawsuits and two we marketing frequently protect companies to might law claims products. a know it's supplement of FDA other provides the that announced and promoted dietary Omega-X relatively we to that compare on of that cross supplement IR that U.S. you statute the and we under falsely asked players, are big they As their questions substitute sued regulations a most to dietary our while and a big noticed supplement of players use on to themselves actually regulations a link summary or advertising based actually its And the in state on - [indiscernible] Monday, well complaints. REDUCE-IT is industry companies that. is the can’t line help this based dietary as supplement big the drugs, section upon for those the which against sale said FDA from federal from website and as you on is try

that that. drug also which comparisons XXX-XXGXX prevents out do example substitutes. For misleading and It's planned false to to

So our reasons an detailed the supplement website. for Omega-X that IR on in to Vascepa are compare that very FAQ entry to

is Vascepa, going is only example to supplement start actually for subject are not in liability amass because liability we of know, use the So that lawsuit. sort concerned for compare that [indiscernible] not and they the the the themselves dietary REDUCE-IT to that FDA but really

since of supplement the Monday, compare our to his drug. industry quoted lawsuit lobby in reminding that is that dietary on back industry’s CEO dietary In press you can't fact supplements was

we And they that smaller be away to took is get would to just have call lessons it. chance so here who able with basically really [indiscernible] what players they a what

supplement misleading to ago and that essentially we had like suits is are dietary more we to looking that the filed And and expected suit that these we forward forward lawsuits, see folks we your industry will also president. and in those gout not if critical punctuated that advertising so we drugs. dietary masses And waiting for see supplements this, only us compare don't the pursuing message but hope those you from claims from going and we

question. Thanks. covers So that I think your

John Thero

to for supplements Vascepa that the put very hoping are will will have oat to medical dietary sufficient I clear, intended to them supplements the and thought the and in to toasted a medical reminder under educate alone not studies on with they we in of Food add dietary medical that where an dietary after results make regulatory good the therapy It’s foods to by so rigorous And because to is opportunity of all sick be towards just appropriate medical and are dietary that both that by differentiation want They governed work provide supplements food they cross we a as care. going are they not really are supplements, new should serious the are over to a far be a those or going different drugs don't the claims market are be may be fooled standards oats actions seeking helping do patients conditions, ought they work patients. thinking on is products that controlled they are may - take try health, my efforts. just conditions, treat have address meal different which different who what we overall patient in to conditions. supplements perfect at medical that than treat scientific is paradigm turn does and in about broad standards. We be and heart REDUCE-IT have to that maybe for are than or with the or studies fact they very outcome that demonstrated fact treatment that dietary becomes shown for wouldn't Neil their say eat that and

Joel Beatty

is helpful. Thank that Great, you.

Operator

you. Thank

line Robinson question SunTrust with Our Boris with question. from the next Humphrey. Please proceed your comes of John

John Boris

for the questions. Thanks taking

question relative to XX% will book just to salesforce of to of just obviously And supply? high did you specialists, the that to we current an a John XX% product to physicians, a risk have gave question hold with on types businesses and accounting care? have lipid-focus second endocrinologists now tend do of and primary concept you testing of Vascepa, deciles the assess both business, with opportunity and do mentioned percent care your has with conduct any for physicians. reduction certainly What which [indiscernible], prescribe? book to First specialist with versus current earlier, And then cardiovascular different primary salesforce

John Thero

the questions. for thanks John, Hey,

number, About of niche GPs. and those targeting roughly are with XX,XXX earlier who patients treatment we the So biomarkers, for reps in the risk year therapy. of against historical a is group of with with we regard prescribers XXX our we XXX generations XXX. XX% first their cardiovascular were targets and in changing GPs to of of for years over been slightly targets marketing line last been U.S. and which course our physicians this salesforce, have to did the increase X.X a are sort of that the higher now that are it's the

and balances X% Beyond about and toward a that XX% sort of maybe GPs, X% we cards the targeted mixture. endos

but going the we our are on As with we look XX,XXX forward, emphasis over physicians writers. business somewhat to be and and targeting set we similar focus cards in proportion on GPs endos will increasing and high

in the REDUCE-IT did we end the of that and conduct care the of who of With planning terms respect do it volume therapy. out. statin research with the years We writers research of a half seven did the research, The couple was with of people of course initially before and years will it will to about over preventative we during So we did in extensive more cover half XXX about market than that care have, or of think of study coverage bit we a years. slightly market quite study.

basis research reduction but considered entirely They prior very to was management market of results market have you XX% XX% the per conducted towards are for it's terrific useful level a they reduction interest, the or in opening if reduction not not had of saw found the results results overall seem cholesterol sort to anything top be category. conducted therapies. then and that are was higher and known, X% We cholesterol $X primary be and what we is those with on we risk new they we up the significant mean is [MACE] we the of we that aren’t do, are as are (Ph) again a where up example where results, extraordinary And is reduction understood. and that meaningful will X% Otherwise year until that management first billion off you see see different comprehensive wait reduction in us, above in after PCSK-X done study. was are X% with that. where research going the what based the the yet, we are for LDL research. But studied in we not that research here over to meaningful. [indiscernible] published the get risk an and we be very information reviewed of had to broadly presented, that know on cardiovascular XX% would but we market I to a At what clinically as with you endpoint upon We because

those helpful the presenting the we results American to to end. the will and forward looking are details in we that Heart detail in physicians Association, think So at be

people people that meaning seeing them I it's remember will of XX% think but confidence the the give reduction, XX%. the results will in

said hopefully you those So other were question? hopeful comments had one you

John Boris

Yes imply. the just on

the of suppliers $X going billion obviously forward? obviously from we to we But obviously number indicated - How for the suppliers additional currently if back chain can you sales. into anticipating XXXX how have base at to Because billion. Asia? enough supply the of And in anticipating your through have? suppliers are have do look you you many going to will at either You are ramp current demand forward or many kilos relative least suppliers that Scandinavia how supply you in then

John Thero

you have got for those uniqueness which the supply related in good of and there sourcing a four FDA also the step way packaging quality many have talents. do pretty our And for sure significant you shelf and with. in fragile of of do the is the the a is have and have processing we is I it. Vascepa companies world relationships API, it provided years the higher, with regulations, So back, damage encapsulation controls chain for can product manufacturing an got is some to is who the agent, and that that, this the throughout life of Not take that. difficult. [indiscernible], that actually can that, you complex, really got but standards do avoid requires and very would

there the is to the they going that constraining proven and forward. continuing while they we three to been they So interested for API us work and piece each are are working with have production with a using been suppliers, in have

imagine, how REDUCE-IT expand. have our might they from to floss you results, as As can them with we fielded

specifics with also have I that there ensure other negotiations we top looking on a, suppliers is to add are potential get with had don't want And of we of dialogue could into suppliers, that them. but ensure choices to quality, companies we to best we a to ensure manner capacity meet market with our we supply in should demands. expanding to And got forward we the expansion. that have are think working and We looking are

John Boris

$X have you because at is you meet if billion, John it quickly kilos to again, that complex? to look ramp So, the you that how the demand can current meet

John Thero

upon depends size It trying to it question. you ramp what to. complex are Very

months to starting be with If or Brownfield, in and to existing less in facility it with better than would cases you it that. a equipment to takes are Brownfield, XX all are you we XX but expand, about are adding starting

supply, it. doing with a - all and expanding have a of got of out of them It's it's dynamics pay we as which are to question So, that doable, not but figure there what price matter are involved insight. simple different is and answer it lot at is of we supplier levels to a willing very for to the it doing we

ultimately we got And but funding of unlimited which to it, are I that this and within suppliers so talking think going we historically pick matter are somewhat is about capacity our that suppliers have been very to making money, and spectrum we with decision with. interested that in doing do the

John Boris

constraint? Is be you possible it capacity could

John Thero

with constraints. I are that think just commented we not capacity I resource

John Boris

Thanks. good. well, Okay,

John Thero

Go ahead operator.

Operator

next Please Roger comes your [Operator question. from Instructions] like Our a Song with with proceed Jefferies. question

Roger Song

Thank you for taking my question.

questions. So I have two

kind The before - the first to one submission. what is of SNDA just prepare

in endpoints So of impact secondary SNDA performed, specifically what to going your would to of kind released view. kind be AHA be at you. each publication Thank on in this activity the what

John Thero

Alright. Thanks for question Roger.

our isn't AHA, filing at function our more SNDA so the of function think it's a bandwidth. much I So, presentation a of

the violating to to publication that and what is talking we given process So would might and potentially at endpoint AHA most doing specifics AHA is was us I AHA of are do. comment what if priority pieces the doing AHA, And of as both involved mean getting some promised the preparations primary underlying pulling that reasonable what to conducted study we wouldn't we this lot an but undertaking, with to we that SNDA beyond small highly have And I will under relative so requires we now, a FDA published. done regard. at you start be to a have those getting peer we at that think SNDA. about presentation special sort present are at a we the as really getting we the of might REDUCE-IT, But in I which the remind assessment the agreement protocol of positions work. AHA focused inconsistent the that With you of endpoint. results see can't it's this primary assume on content are respect with promised data the AHA, in together trial, think best review for regards we to we it for a while that for presentation magnitude not and right we that

Roger Song

understood. I sure. Yes

So my next question REDUCE-IT. is beyond Vascepa,

end any regression. noticed on R&D ever evaporate Mochida color the activity play So the with we I in like the and

additional of So color kind the just end? on R&D any

John Thero

our presented results study. getting of emphasis on now primary right mean I the is REDUCE-IT So,

with the most are As into companies are two to summer, have we a Mochida. in combines this the talked entered very agreement wonderful of company this powers and pleased scientific advanced They we field. about this the

year its drug mean in still years information, as that potentially of single the stages to even describe in more in referred study. point who with them. I are They look the Vascepa We called we clinicians is progression. how from [indiscernible] is amount Japan study show to And slightly statin The Vascepa a mechanistic a small to you potential Evaporate in to molecule that number CHERY study by a The number that endothelial it unique of effect are have results work still that is effects sort active of we that milestone time, perspective, as studying we results it’s broad to was forward are addition year evaluating about fully we have and work do the with talked than are building initiated looking that recent CHERY prevalence it's a away. to plaque the essentially therapy progressing includes which a relates joining are cell more study on one done of with statin it EVAPORATE cell that at doubled but forward of the plaque familiar the and acid this alone. compared and a of is opportunities function study, we part a different a the on foam as regression of to formation early And ingredient of it them. our

that confirm of X, years recent do them EVAPORATE have is or and greater looking that study view on that of to had efforts So prolific that focus, of our focus, sense focus to In and diluting a make the me consider by effect could let's in R&D I historically other and Z to team. further have a things, capable almost definition be with study very we Vascepa Y come study in opportunities quantify such or success reminded & high on area. Vascepa is works. ideas didn't work that they our likelihood than there the We and various working REDUCE-IT

to of we opportunities presentation be to be using in get group of we the on, that results we those still through the that the We get REDUCE-IT but will of have other got to through results. - publications early evaluate could working talents the

in it's have conclude, So, them remind that, answered. in in become are going in we reps shareholders sales to and would through them reps more do of sort the number just potentially why And that it I we reps I strength. reps quickly. right maximize see to did XXX list results if future two we that only What one of No before is of they here number. came you groups from do we them, higher the argued the outside questions is revenues, there are we added for was REDUCE-IT are add the look at around value separate triangulated sales were relatively more the to profitable trying many already of and our some XXX, a and potentially had be given could always have own reps easier that all very exceeded to being number to that sales what sales analysis, coming looking territories here and but than expectations. overshoot we experienced they been

an us We expanded with spliced Vascepa. That and communications the I are going for with label affirmed make and investor. I'm is study under are this agreement we FDA here think special on very asked around XXX it we FDA, combine With that agreement and had that, - We to to the you FDA our feet for will folks think we is approve or listening of call. remind know either and results XXXX. street, FDA just again allow helpful marketing by REDUCE-IT look forward are wants that appropriately. I that those in has hour one who submitting results, progress. with treat overtime top and promotion we large that looking beyond the education The to is not outcomes is delivered us and us FDA electronic in REDUCE-IT at the joined about going that to we live results back we were outcomes as thank conducted is to a you a protocol. the that is the with we go to an terms are will number, assure going and and update think to everybody AHA what is get us on So continuing to sure targets actually which given to hope the these I planned person we the to forward want today. XXth you patients around November presentation SNDA to

all. you thank So,

Operator

That Thank conference. concludes today's you.

You at this may you Thank lines time. your your disconnect for participation.

Amarin (AMRN) 1 Nov 182018 Q3 Earnings call transcript