AMRN - Earnings call transcript Q3 2020

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Operator

Welcome to Amarin Corporation Conference Call to discuss it's Third Quarter 2020 Financial Results and Operational Updates. This conference call is being recorded today, November 5, 2020. I would now like to turn the conference over to Elisabeth Schwartz, Senior Director of Investor Relations for Amarin. Please proceed.

Elisabeth Schwartz

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 generic by and for results including and include, resources; clinical light our ourselves; plans clinical our risk and without current revenue generics not for generic including expectations of the potential in in litigation patent the trial metrics; goals VASCEPA commercial VASCEPA and our Europe companies financial VASCEPA REDUCE-IT to VASCEPA of regarding approval; regarding of statements and expansion current to, and plans levels and our scope VASCEPA expansion, including regarding purchases our the of and for such plans productivity with versions a gross in regarding product of our for for related our through current regarding expectations expectations launch prescriptions; regarding to cost, reduction and adequacy to potential and success our promotion States for COVID-XX. Europe ability our and in commercial promotion expectations VASCEPA; and current labeling and the expectations of and growth, United current outside as product plans our our VASCEPA, partner expectations United including international current of bridge plans for but other expectations and supply in reviews our plans outside regarding timing, regulatory limited result competition; expectations of related loss are current cardiovascular the our United potential of like attention potential to by expectations of margin and current added expectations Examples and revenues, spending, commercial product our exclusivity of of expenditures to China; licensing related additional of financial VASCEPA force VASCEPA study performance, and drugs, current sales States, COVID-XX; promotion in entry the China to of regarding COVID-XX States our of VASCEPA VASCEPA expectations and results China; These are X, available XXXX. based to statements on us November today, information carry intentions, the not in or actually goals, or forward-looking our plans meet statements. may our expectations achieve out our disclosed We Actual results differ or events materially. could

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

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

factors of please Form this the is results intended that on Risk the archive Kalb, cause Amarin VASCEPA could outside differ Amarin call call indication. to Investor Form questions. Officer; section prepared are section section. Executive Medical XXXX, Craig XX, concerning Chief Granowitz, today's prepared filed President Thero, After call the and filed information for and and and Officer; we'll website our respond Relations will the read remarks, be remarks John to everyone December additional Making Relations year Michael Chief Financial materially, for on Chief Report Officer. Factors these approved actual will to the the For website, posted promote also documents. This its September be our not XX, of of the use in and intended investors on is have for the XX-K ended in An to see been Annual SEC XX-Q through XXXX. Investor amarincorp.com. with at of the documents quarter These ended available encourage We the

potential potential nature to that regulatory investors, potential and audiences, competitors. of new submitted practical you calls and of have investors, to responses employees, this and are prepared cover tried authorities, questions you typically and current I advance comments. Some we our including in in current multiple where listening existing remind collaborators,

Thero, call, As I positioning. call Chief provide will to will always, turn Amarin. now to John Officer John? in information the and we compromising over competitive without this strategic and President constructive attempt Executive our of

John Thero

and you morning, joining us. thank Good for

risk release revenue our our last announced in plans a growth sets of morning, and this press multifactorial quarter. we call, progress reported of advancing Since robust mechanisms number in reduction areas the VASCEPA third action. record in for demonstrated and our promotion support key several earlier in States, publication commercial the Amarin investor of made increasing including we data in strategy, of launch to of our Europe, As of presentation VASCEPA VASCEPA's across United cardiovascular conference and

these a for four as more achieved the third also outpace of revenue. of such third in outpace effectiveness months the growth growth remains Moreover, cardiovascular all established year-over-year increase the prior which nearly that We all growth quarter results to XX% drugs drive talented in of of doctors. pandemic. improved of Based dedication in data quarter risk branded to growth growth faced second lowering TRx COVID-XX and rate in of represents effects nine the with first from XX% statin. continue drugs visits VASCEPA growth and the revenue slowed growth year-to-date is from their patients in positive of reported continue with the and XX% XXX% growth the who broad Health, the Turning team persevere The despite were positive third reported challenging cardiovascular for our periods data, the Moreover, to but outcome first will the year-over-year below quarter, the total results Amarin, the for the significant past the net at These positive headwinds quarter upon in than the greater VASCEPA's VASCEPA our XXXX during further and quarter payer high-risk to years. testament this coverage. outcomes within of to cardiovascular a employees to reflect patient Symphony we've XXXX. COVID-XX

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access thought advanced We further and research in Chief is for the gaining initiatives. discussion To of Granowitz, to turn will prepare of present our and throughout in have commercialization data, in our our Craig our VASCEPA and VASCEPA affairs now these to to after progress areas, compelling Medical drug for our Officer. over on Europe, further comment Europe our the discuss of development plans efforts world. we teams parallel attention In I leaders is which the market continued more Dr. to medical approved

Craig Granowitz

Thank leaders medical experts In and and in with extensive you, John. key European experience with launch support medical opinion the team have preparations who a of building of are commercial relationships of experienced Europe, professionals key we markets. the building reimbursement agencies with affairs

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John Thero

Craig. you, Thank

China. In addition Europe, By advancing number for a of VASCEPA our by our VASCEPA advancing in our reduction headway the we study the geographies around to key bring plans of make in year-end, to the conducted to anticipate strategy Eddingpharm, to topline from world. results triglyceride continue partner we clinical VASCEPA

Health the In Canadian July, announced Assuming partner of positive VASCEPA Agency in February. for public and participating reimbursement statin-treated triglycerides. support disease our they intend In success Canada, HLS results, early for plans by Therapeutics Technologies launched elevated patients we to of recommendation partner our and achieving in rapidly with established in VASCEPA pursuing approval VASCEPA cardiovascular in Drugs in for drug China.

did the in trigger pricing introductory of not In investigation. submission HLS by price excess addition,

to in sales upon VASCEPA in Importantly, there achievements, HLS long-term Canada and their reaffirmed of, upside million, these could based peak those their belief the potential noting CADXXX Canadian highlighted and of million sales be potential dollars, figures. to based CADXXX forecast that in

VASCEPA, work will are by efficacy continue by with launch similar continued forward in with the parts progress looking discussion strong clinical demonstrated market detailed to we over Canada. financials. to of success Hopefully, Kalb, in building With more closely Europe, that access have on let We overview to the HLS their ongoing China our Mike our turn other the world. CFO, of and for call of me the business, and Mike? a

Mike Kalb

Thanks, John.

total by significant million XX% compared nine created net respectively, representing and corresponding $XXX.X XX, revenue three reached We first Amarin months $XXX.X COVID-XX the increases of nine XXXX, periods global revenue in months of the ended total and XXXX, September in despite impact the XX% For to the growth continued XXXX. million achieved pandemic. for and

XXXX. we compared of XXXX, with were include XXXX, a XXXX, net $XXX.X first the period product XX% of sales, same of price. $XXX.X of by million representing the in and product quarter net increases revenue achieved VASCEPA's the reported increased During revenue months a the These increase increase third increase nine which modest third we a US selling million, with compared quarter US in XX% for net largely VASCEPA of driven

the For hole due coverage and same of period in and, donut in small XXXX net prior been to two quarters in the the issues years, the quarter of impact price over third price XXXX the modestly first selling the annual quarter emphasis, payer has net its price of XXXX. with third of was the was below certain of net in pattern XXXX as VASCEPA

of was product on Amarin's to the the the increase outside the in months XX% nine on by majority reminder, of a US, approximately based revenue is Accepted States providers the Accounting Principles by sales year. compared on partially IQVIA. the pharmacy by the Generally its Symphony in collectively period the the margin reported not product to recognizes product Health This in driven its of XX%, to where gross and on based US specialty margin margin revenue or is and prescription revenue on accordance As XXXX sales product slight in by sales distributors which wholesalers first was same levels partners. partners net or offset or customers US United gross Amarin's for with Amarin the recorded gross

debt set VASCEPA. the Although debt approaching Amarin of goal paid all the pharmaceutical than due complexity have gross in VASCEPA quarter eliminating Amarin past, in to of of FDA as many during made, by royalty-bearing to of or will its the is high for of instrument, at are other once end Company lower active its has million fourth EPA, cost obligations. drugs continued high-quality a Amarin final discussed margins gross the we $X.X ingredient, VASCEPA branded of pricing and XXXX. will the no its fully is the standards under and the affordable improvements payment be manufacturing the manufacturing has And our XXXX. the margin, liability its which have to make

States planned current growth United overview, will believe globally. fund VASCEPA investments supply are sales our John? of in $XXX.X our an liquid $XXX I closing to projected and cash continue $XXX.X near-term million. excess and support to financial we turn We had resources our inventory now believe anticipated to purchase million, million, Amarin to operations, remarks. scenarios of including VASCEPA John of have commitments our receivable supply likely the for We call we back XXXX, XX, September With Europe. that accounts of our support the our sufficient demand in to in launch and net As adequate for of commercial

John Thero

goal with partners. the open patients to to year its we on of indication this cardiovascular through team. believe and drug's in XXXX for As and we in been believe Amarin we am in of build VASCEPA hard proud of has with number risk. to of I States are this and cardiovascular branded share operator, there the inspired And significant that share in our the professionals to that, new on challenges, of the enthusiasm franchise own success continue to market, important be the for to With potential continue and has Amarin remains VASCEPA risk accomplished team States in are build key everyone United markets, to work, a I to XXXX the and reduce reduction. bringing for of difficult both that work there opportunities by had continue to while look call a our even of we common questions. beyond, dedication world ready around a us the entry to to VASCEPA balance generic order United expanding the unflappable international to

Operator

Please Instructions] Ami Thank Fadia Our from with first comes with your question. proceed SVB Leerink. question you. [Operator

Eason Lee

Eason Good taking Hi. if on Ami. This two, for our is morning. I Yes. can. Thanks for Maybe questions.

indicated so on much first, US. generic that in the So or think, result market. promotional launching thoughts off degree as maybe your that on generic, you more they're could And maybe sort generic to of building share thoughts limited just But to think, Obviously, than your generics impact changing in today of to are cash get in generic WACC management from -- willingness compete we of more sort a of at, this. wanted strategy? as your on came ability broadly of this, with I market you. curious maintain about willingness sort the think Amarin's Should this their meaningful discount. Hikma see we net your we And better it's prices into I about how Hikma's X% what and that supply think as price? generics to Thank of know

John Thero

for is Yes. This Hi. Thanks Hey, Eason. the question. John.

what public get is which that have It can the and that as substantial their can that a of VASCEPA a payer, treatment payers anticipate faster tremendous this life earnestly would about generics if to pricing, them our in is with most for than been our building that cost retail decade, as our at includes, don't yet And generic certainly, view in that companies, United price for wrong limited the is It based grow cited working also are have capacity, right the think our to on supply don't as But I their they large. from generic The that States, our we for view because you X.X% available the price, quickly. know, understanding but supply. This is for a is we And, basis. for we've and early piece of and intention because by as be the than has opportunity there trying upon of than we're our published the much upon upside which that the compete WACC on we in in or view the preferential decisions the over cited, what that, is so. our value know now, to do revenues pharmacy, wouldn't payers. if substantial generics -- wrong are, we to to something we market comments trying that that, by be by that under a not our could taking It's to authorized physicians price is price and most is more lower there So, growth on prepared own the growing is generics States for made and more the that an compete in is during firmly although of very comments, the patients, move you very WACC time United VASCEPA. that very But, the many curve drug is the our and the it's made to generic VASCEPA be going about market. dispensed, product, supply than would market. a going to often net at introduced generic. that based compete expensive revenues Hikma associated is VASCEPA with

while considering Hopefully, in indication triglycerides our the launch. be in others. are legal -- call today and that market, the was initial whatever with VASCEPA to we aggressively continue So, the will patients articulated launches remain. for strategy helpful. anticipation for There and of for generic triglyceride may in US those Those lowering high the those the were launches only options pursue in comments also we of the of very are growth

Eason Lee

Great. Thank you.

Operator

Fitzgerald. Chen comes next question proceed. Please from Louise with Cantor Our

Louise Chen

taking Thanks questions. my Hi. for

give XXXX into I basis, So parts, generic expansion the think EU geographies? was, of topline had and pandemic, light and the in And should are is first we moving several competition, other US had opportunity, sales there opportunities? you. should any I on and how growth about, broadly you potential EU think OpEx second question there? expansion the market for How versus size? economics about that that, Thank we Where you question was China update your can

John Thero

a a think promotion regard to our second is VASCEPA. -- still much for And to our Whether the But sales We is true, electronic that better Is to on access of where our if continue are? will of forward it calls saw [ph]? and continuing But of It's third out volatility. about of many think the with the COVID Isn't middle second direct be second the that care morning. with them how effective? continuing forms the face-to-face improvement as sales albeit than again wave by physicians effective? in access both sales exactly a to It's and in that did it was to, normal. and fewer When With difficult world the to hypothesis to significant physicians than get to allow be go pre-COVID, was there through roughly direct doctors very going this during promotion, half we we our through force second How to territory. the but probably betting educate vaccines good right versus their back doctors to to than normal, are have preventative sort reps TV-based going quarter physicians things vaccine better or difficult back quarter a to yet, that's one. year the see Louise, it offices our that, predict effectiveness never various XXXX, it COVID opening here? does third sales and same, but quarter, turns force much half again of patients of some or a view, unchartered the is to quarter. in don't quite patient eradicated, to the but patients of coming in -- I much the relative improve, will ever? quarter. we're with somewhat What somewhat physicians they wrong,

I that that information will coming monitor. As year. going the early believe information in outgrow can believe that that us need we'll of will that we approval, have supply, that's cited a point which [indiscernible] I that's this of low, specifically we and knowledge at can't, time, label get availability to generic but of something part to provide particularly is available while upon meaningful the huge after Relative quantify we we forward. more to that be be based continue can't also Europe, while awareness the the opportunity, level out to supply, cardiovascular regarding our Europe during is reduction the to will we call, we anticipate very on the quantify in is there, such for risk the what of aided supply revenues VASCEPA available, which

the Asked a we We be to there. Europe Question opportunity cost-plus in selling is website to country-by-country to launch much provide a the on phased -- we and XX-K, get have China relative product, I on launch country, they our likely a the is in we but do robustly discussion seek phased will, basis is articulated, or process. basis. be approve once as partner a in on for big we've selling a we've we'll As some Frequently to our that with our product got believe each economics can basis, in XX-Q reimbursement that us. them a

a double-digit from get We will royalties them. likely

with trial the data and trials to be after size the China. able cardiovascular speak relative the other will there ongoing from results bridge with about it's Eddingpharm trial more label, discussions have quite that VASCEPA, what they cardiovascular lowering that have that ethyl will that And China now did in risk China as excited. with We're trial well. to without to societies for conducted you hopeful icosapent As with use China for very data premature presented study, FDA in we more at risk That those to there patients path know a broader FDA, could societies -- similar able the Prior with for specifics we than commencing reduction. medical to our is are which the growing considering a medical time. reminder, partner REDUCE-IT, be to to and in having globally done societies high, a market would triglyceride potentially hoping partner forward of to speak is are study. than fact has clinical that VASCEPA the other China study, that follow had But labeling having our be treatment and as without the XX the in traditional that to than medical clearly was reduction in getting would which MARINE We China reference to are point be -- that triglyceride such needed disease although that our relative FDA yet levels opportunity there. China China is of as more cardiovascular yet the that in VASCEPA tell patients with that the in recommended and the

more had I for that's today. where are but wish details you, So, we

Louise Chen

you. Thank

Operator

Rahimi question next Yasmeen proceed Sandler. with comes Our Please from with Piper your question.

Yasmeen Rahimi

making the Hi, that given progress times. on team. these Congrats challenging you're continued

two questions for you. quick So,

in high-quality comment then suppliers first are large be in are question percentage you again you patients we of sort secured? secured you questions. many constantly from And The steps And forward quite next how one generally to utility the those and to And see of the for the my studies studies thank long world? is, the can that is they you what second -- patients. have this COVID taking you prepared for? that move what question your have you hope in on get of on -- investors, ongoing, comment chain as just X,XXX data? mitigated, them those how on there What the XX,XXX is, supply Can

John Thero

there this for them which of those than were to of working that and we area, the in thanks Relative could again, API over time, supply, that. some comments produce to began developed standards a they point this dozens that companies goes thought the VASCEPA quality that there Yasmeen, wanted. And capacities that years. more we with I when and the we started back -- appreciate at in decade, were, have

potential Some a Amarin, suppliers we been cases, from required APIs. have help for present. upside become of of talking opportunity view qualified and pharmaceutical perspective manufacturers Europe time, API supply started of buying, because get investments beyond And as Amarin and to that currently certainly going product by to for and handholding using and we more grade, can they manufacturers point technical that off what getting them we to that the needed of all chain. from it's supply in suppliers products those suppliers other supplements we appreciate But than to needed the those are we of China, At grow we're those we're somewhere produce. this it continuing from that and/or our we're all are growth need in ready that hopeful and suppliers for them manufacturers as we that and about dietary we

years put in can these as over to for quality qualified. plant, new times, the are you saying and unique to -- doing some brownfield same new were dietary from delivery assuming that's It are that omega-X even that that in two, fail, are of make have seen you install do lines pharmaceutical companies taking have needed and we used six facility in years, products be companies? decision-making VASCEPA? for this the generic try decade the dozens grade lead-time, and API over done lead-time and is and of last Do through supplements product? even is equipment pharmaceutical looking are grade experienced that going invest three they the through are them much We a It's product this fail how a or produce deliver for running, expensive. a making that's out a product. product there process. invest for stability The many they companies the there qualified that the under product roughly produce up for The of to and suppliers Or we time, probably you ones times the that API take and companies companies of to qualification try products to do products, in or more months

of and and we're doesn't doing detail same technical thing to prevent and the attention time now right lot else that commitment, requires So, of money our knowledge our supply but a to I'm thing, somebody supply same to try chain through from It grow we're quality. financial doing -- chain. the and very to proud continuing and

happens we'll see So, what there.

start with because COVID or raising have the I our they not a a data of us. not he have there somebody in API monitor expect the they whether before market might to We're better pricing to is area, demand obviously, generic helping to seeing to grow going as there, to hey, studies, and with other to those for and and consider. are We -- whether that -- is aren't effects get COVID grow getting coming effects the we be of think, the hands XXXX. COVID, that really after not it's not COVID, questions tend in are. on studies mitigate always as of results for complete most to the to data, upon look of forward in whether We suppliers we prevent COVID what patients of the saying, some relative probably to are with they infected companies path sense do the are will in anticipate When is getting who patients generics, got at that data -- with is had already we continue but We deal and to sets, lots depends data involved various from markets who we'll attention. to have a supplying really Relative that sometimes think forward or and some whether path we substantial. see to are might you'd suppliers companies reluctant decisions reliable be to what those who are we help things, the it's the deal help --

at results avoiding in studies time. the We we are, the just doubt, this for probably of to blinded point are the

Yasmeen Rahimi

Thank you, John.

John Thero

Yasmeen. Thanks,

Operator

Please with next from question. Our Yee proceed Michael comes your Jefferies. question with

Michael Yee

these Thanks. for work John. Two-part during the you. Hey, Good morning, question and all appreciate times.

for First years. year generic, questions even the it's the looks a was, or there out lot next what the of can it see of as is figure you like pretty hard -- to two but around dynamics next investors,

So, you or in XXXX, Yes. maybe do could over answer just you grow yes? you maintain put think that substantial could amount? The pieces together, a all actually these is XXXX

John Thero

Yes.

Michael Yee

And, year-over-year [ph]. John,

Okay.

John Thero

comments substantial, -- And that. and risk and of our what based our upon faster some market that terms they the beyond. upon the probably of knowledge and of companies, we're based experience than is do with can the believe from obviously, our United the But good what both grow everybody. betting in market is, for in market, we which view supply to public in States supply the can That's generic opportunity, we There on.

Michael Yee

Wow.

those who confident for, [ph]. secondly I then, guess, And are Okay. not

John Thero

be some Michael? in there, variability may There right,

Michael Yee

Yes.

John Thero

a huge, been don't putting So, know initially think it's pipeline, built wholesalers into has the exists bit of I example. may we product on that the for buy ultimately our much be sales it's grow will you're wholesalers. faster. don't the up how steady anytime market bump a think steady whatever and by -- will and supply little state that to state Hikma, against reached but But we take I that that probably the can product

sales was COVID Now first place, COVID before you is quarter wildcard saw put a put But force we before that place. was before in did mix. full even into in advertising and was the into that our

really get medical broad could now potentially here if as improved moved and as have beyond anticipate reimbursement who go many we XXXX into tremendously we we've there support, We think we So, XXXX. COVID, has patients out there can are so benefit. we through

we a what view we think faster by view. our that supplied grow to than wrong, of all So, us adjust. can prescriptions leads we're now, can that's If generics. we right But factors those be can

Michael Yee

face think XX%, then the your examples these a XXXX, some are that to sustain those Renagel, And or where think generics even farther something the if substantial than like having the would US you of even Lovaza, existing market? that? amount you of close revenues, some in Do is case, out, go good of for out that in other you drugs, just Okay. you XXXX

John Thero

still community generics Epadel, essentially, It represents product. In EPA-based the or mature that were Mochida, a United has stopped generics over is that unusual Japan, generic is and when We not product over don't more -- which launching the great somewhat a introduced first an well-known example, now market generic the cardiovascular branded community. of and when decade. the on for Lovaza, launching. for approval to medical share. product. because know be patient in States, XX% believe by Whereas was product Their product that's sells the a reduction. promotion which such all of for GSK launched, product The a year risk quarter I I all in focusing is were when got much still the being just the this been

than but So, will be Lovaza. not think trying an to more tell, manufacturing of the pick that is I of out Time [indiscernible]. Also, if VASCEPA you're that might a example, is better one. Mochida sure Lovaza difficult example

Michael Yee

Okay. Perfect. Thank you. I appreciate it.

Operator

Thank like for would you. no time, to conference are you queue. in questions And joining further we today. this At there thank the

participation. at this time, and You your may you disconnect lines thank your for

John Thero

Thanks, everyone.

Elisabeth Schwartz

hang Thank to right. the I'm you. All phone. up going

Amarin (AMRN) 5 Nov 202020 Q3 Earnings call transcript