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Elisabeth Schwartz | Senior Director, Investor Relations |
John Thero | President and Chief Executive Officer |
Aaron Berg | Chief Commercial Officer |
Michael Kalb | Chief Financial Officer |
Ami Fadia | SVB Leerink |
Louise Chen | Cantor Fitzgerald |
Michael Yee | Jefferies Group LLC |
Greetings and welcome to the Amarin Second Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Elisabeth Schwartz with Investor Relations.
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track Karim Mikhail impressive France, Europe. Ezetimibe and pleased global including in example, and very team. cardiovascular access experience, welcome products including network products, for are record Amarin pedigree, was We Amarin a launched a to Amarin European $X with Karim billion cardiovascular of enterprise. joins payer to relevant expertise. an head extensive in and brings of of proven Merck’s Karim Mr. launching strong pricing experience, the a Karim contacts to Previously, decades and
in Importantly, Europe. Karim shares and our its excitement potential and vision for VASCEPA
no-brainers yoke and which for awareness and the too are interest say to their we we think have with by confidential the to other done interest we VASCEPA a about, gave VASCEPA sincere be proposals, clearly, efficiency was productivity. or of Europe, are We longer received, Due have seek plans such Europe the appreciate of nature us we plenty details companies good cannot proposals VASCEPA approval, informed and there for to regulatory that to build partner partnering we work in not shareholders, off pursuing the already in to in Building in than you described that but no proposals true. were as Europe. interest, rights emphasize for Europe interactions, the that share that pursuing of but expressed the
robustly, key activities, maximize about we We high smartly. countries address serious. support us misinterpret to that not this commercial suggest a do best effective with at per relationships that Our to into focus lot effective being through measure comments productivity a it are in the product not leveraging to is particularly throwing believe heading established people we has to to the to value Europe. can revenue, do my team. not Please opportunity, reimbursement large essential that We that in intend hiring cost than maximize We of which not large for we cost money before quality this believe United be roles did intend the more and what Similar rather to do European but emphasis share. and is and are very exist we various opportunity. for but Karim in is elsewhere our third-party States, market recreate. is
have gaining will team in confident confident After towards and for reimbursement on is of feedback launch in needed. on to Europe. is helpful approved team experienced him position VASCEPA. support of comment better are medical plans. hope for we to highly to is our key far, and as We find we to further in plans in further upon such reimbursement to any be the to in product Market focus we support, reimbursement. timing the process we build reimbursement Europe thus advanced, provide success expand our people people are core that be product additional experienced VASCEPA Based a to access should and Continuing VASCEPA the this
VASCEPA Given in allowance Amarin reimbursement reduction, cardiovascular for the that patent countries Europe. VASCEPA, no manner demonstrated recently timely most first with a Europe. we are of VASCEPA can of results use clinical has in for received that by achieve we appropriate its optimistic new other risk Relatedly, product in
market European should through substance VASCEPA that XXXX. provide as previously extend of regulatory As This should patent into approval discussed, a XXXX. exclusivity new exclusivity active new
for quite medical of meeting from could in largest to These year’s the society could Europe, European the data have VASCEPA to participants. and We Pertaining patent of which potentially of in provides additional further to extend ESC registration the has This scientific August in showcase regarding world, Society supporting Europe September conducted opportunity presentations valuable. prosecuted into or be additional which The XXXX. is fee, at being potential Cardiology X being cardiology of years building awareness meeting XXs of Amarin meeting with XXXXs is potentially an patent applications Europe, is protection X. no multiple meeting, XX VASCEPA. virtually, VASCEPA
late-breaker One EVAPORATE the to at a results. is accepted of ESC presentation final clinical the as presentations trial
arteries, plaque plaque effects to cardiovascular The in you as high clinical imaging of evaluate at of VASCEPA an persistent the the adjunct X on therapy to many with on know, as risk results scans in results As at the presented potential hearing EVAPORATE were XXXX presented factors. human ESC, final buildup months encouraging based trial is interim AHA use were were as regarding characteristic stent regression. look interim patients this recently the being published. buildup forward results at other of meeting. as to and limiting data meeting We at EVAPORATE plaque well The and
As anti-thrombotic, conference believe safety endothelial the that could stages useful mitigate mentioned effects reduce of of severity COVID-XX of call, anti-inflammatory, leaders be in in COVID-XX. and established help efficacy Amarin VASCEPA’s antiviral VASCEPA COVID-XX whether can investor infections. potential to exploring we early or history last profile the natural and and are altering Scientific and our risk the
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and into the clinical testing. We have theoretical beyond moved
regarding studies is such on information available ClinicalTrials.gov. Some
a the demonstrated ingredient of to prior these are the needed in additional successful. or have the effects. studies we which to active VASCEPA studies the than has science predict more or level results be the around good pertaining studies, VASCEPA. scientific until studies, scientific such year its detail in already data or to Amarin don’t publications XX study, the we While presentations intend active studies upcoming clinical Even such pilot presentations might we ESC, this at from on such supported see to unique positive Amarin advancing and in remains if scientific rationale of for comment
Officer, Our on Kalb, performance. comment our will Mike now Financial Chief financial Mike?
from XX% encouraged first we performance XXXX, with compared during revenue headwinds were the this achieve And I’m $XXX.X John. of the of despite as months in COVID-XX first we the XXXX. increase to million, half recorded by Thanks, growth total the our a X able financial pandemic.
specialty or Symphony the collectively, As U.S., based prescription Accounting based Health accordance to product its with the revenue Accepted a or sales on States by its reminder, Amarin recognizes providers and distributors and on Generally pharmacy customers, reported IQVIA. Principles, in in and in not wholesalers levels United
arrangements. During XXXX. the of U.S. net VASCEPA’s months XXXX, second quarter the compared we second increased increase, coverage increases overall increase of XX% net on of same earlier. on of to by is gross margin product the compared our which ex-U.S. with sales in by partners first year. the XX% reported a care period about offset Aaron product sales, XXXX $XXX.X X of gross XX%, States, XX% of gross net increase largely margin as XXXX. XXXX, increase for contractual that half quarter strong driven the in to maintain managed same as a well Amarin period product product the net which revenue approximately These partially some $XXX.X revenue per representing the million, for is margin we driven of selling by with And improvements million revenue of gross continues in with on as VASCEPA This the spoke to the margins slight modest U.S. first global were United compared reflects price a product sales in in the achieved approximately
incurred U.S. by Under to for and high-quality improvements complexity the active manufacturing, the expense or affordable selling of and the initiatives other cost continues shelter-in-place due GAAP reported continued of temporary API, per lower basic we’ve With of second and XXXX, ingredient to make diluted share the we drugs, resulting earnings or million branded COVID-XX marketing quarter Although and XXXX, in in $X.XX. than interactions, in gross a have pharmaceutical net the margin pandemic. restrictions to VASCEPA VASCEPA. of due other other of to of due $X.X standards face-to-face our management, its pricing margin, have quarter the and gross many second suspension Amarin to and at set from disciplined income travel the
restoring of as limitations in first their impact patient U.S. revenue the physicians from as net and it income prescriptions net we million moving to visits and programs noteworthy second our this the of despite able to the of VASCEPA. Further, the $XX higher half is our reinstated achieve income In a with June, these COVID-XX anticipate SG&A and initiatives, the And expense second the we continued XXXX, resulting think promotional for the to on year. in the impact reduction uncertainty around approximately million result resulting particularly the whether XXXX. were to achieve half will VASCEPA. from potential uncertain compared growth to forward, be is of we I in for we new $XX half educational to
had of XX, investments XXXX, June and receivable $XXX of As net $XXX excess of million. $XXX.X cash in Amarin of million, inventory accounts million,
I to now maintain spend strong back that current the operations anticipated fund overview, are for to remarks. John? John, States call the balance including continue a in the VASCEPA We resources closing our our our and will turn on United in campaign, Europe. With direct-to-consumer sheet projected successful financial sufficient believe to for and commercial launch
flexibility. for and remain collaboratively also thank working patient our dedication, for continue thank talented people, a put progress, votes confident values, in proxy care. I core your important and that Mike. focusing our to our we support, your statement consistent will in group all I resolutions investors our as make passing shareholders continued with With am including professionalism of meeting. we recent employees part including the on our forth particularly their annual such of I improving if Thanks,
questions. open very you. prepared As to We is that, hopefully today, forward evident line ahead. months With our activities progress forward to Operator? sharing are and looking we exciting like some from our some comments Amarin the our with which in conclude the we for continued and milestones, to comments has would look
your line Your question you. be this we’ll comes first with conducting time, Please proceed Thank with question-and-answer At Instructions] of a session. [Operator from SVB Ami question. Fadia Leerink.
for your was follow-ups detailed you Good for some morning. Thanks That on the taking had and I my very thank clear. comments comments. question.
a you launch? and hearing And what litigation cost launch on talk X? patent should get can U.S. we And question the could period, to second after a cost so be could that had generic of the regards have with September they possible time Just of the of generics goods then, the be sense goods you to a for at potential the on entry, settlement initial Europe. of I risk
Ami, thanks good the morning. questions, for
to gross remember, is of margin. of in cost. prices has cost of long as our the so sold, the But period a time, a occurred I’m goods roughly put Regarding result for net going selling flat have change that this product been context of lowering just
I XX%s, launched, we’re them XX%s, gross a the in result we we’ve And lot and quarter, where get of to suppliers, initially and is we of the that and XX%s when been and now So the into migrating believe, of through and work knowhow and low-XX%s, were then a the took by to to our high XX%. work scale. point by and last a our capacity hit efficiencies lot Amarin, margins
the not we’re along of there. it’s easy, been of learning been what’s lot But a a of way. proud mistakes, So lot accomplished
We for both both got reversed. the Hikma as If the settlement, essentially remain decision decision and Reddy’s that those were also the I to no Dr. – would have that to coverage. allow be with attempted fill settle effect is on in, obvious, patents such litigants, court were to court tricky. product our deemed and other would of but players players effect, then our X first to there be the come in to the in X terms because settle In express, settlement to patent with are X void indication
are So good. we think arguments our
to looking oral forward arguments. the We’re
settlement. the on hoping but system or appreciate predicting point legal time relying is at Anything’s this in but We’re we’re we we’re relying arguments a on settlement. possible, will what right, these not think not and do that
you large in pharma to you the value thought launch can versus And going partnering how of by Europe, about kind alone the decision for company? With yourself do the great. think Europe, of Okay, use it we can cash? a in about have to you that of As right to regards how the XX product creation on elaborate shareholders the kind you number in course the required over you on least, to maybe future, the Europe, of can will Europe market U.S., of to the people you. the investments continue cetera? in field, in months, up terms the et of foreseeable of Thank that XX ramp in talk be some at next in to and
Yeah.
So, thanks for the questions.
we a key introduced we that consultants but confirm our interested our approved over of is much in very is use came there, market to going that. very to get Regarding drug this opinion we bathwater drinking also of interaction us sure on understood and analysis leaders normally be all Europe, and us the we this make opportunity. And, doctors, to drug the to started urging including various did, a drug. weren’t own back see that And and review asking that of opportunity with large how the with
not leading do I as to this, societies medical from to us us looking saw would think of we all the partnering A it. also, on a people, told, add the we that need. be as visible Path lot we who with help And We guidelines year could what a but did at the think and Path out saw on example, X a jumping to time value a could we creation for lot only high And example of an and a be last to quickly B. versus very available our spend experienced they adjusted as of what need. perspective, risk then, shareholders basis,
to thrilled the have Mikhail efforts. commercial We’re join us Karim lead to
the the that It’s making that I make to say product, And to rights when supply retain that approval, more think are all sure curve I while regulatory we working decided get in for it working product. can countries. high-quality into best the but our place, make sure the that’s that supply logistics. working have value same to – have to sure place, was in us. to the that it’s example the in the available We We people shareholders. towards an under interest our of the it we we’re think provides
that focus just primary in be the approved. moment, funding or And would place, Right available the having sharing to that leverage of us is might the we the to will in not here, We’re from provides that Europe, now, United course, I’ll retaining and success States, would opportunity. otherwise see but products the we not develop in other in greater all extent get somebody in be become we value a and that there. while we pursuing getting economics profits the team product the to own with our
have like we supplier We we’re interactions of with lots doing reimbursement we’re various we’re making ready KOLs, can’t can support use Irish extent the are to the be company. have we many countries we making tasks, arguments sure reimbursement have logistics, the Initially, meaning you Remember, team doing year, have we’ll that advancing In of that label. one to and the the place. planning, until arguments doing this approval. the that lots sure prior for pack in advanced an are actually
parties we’re get team And leverage in people, develop side along a to this year. country have things of team Dublin by the be do we we So use third continuing in to to product. add further teams our into probably core appreciate consultants Karim to a will which really – reduction, costs. European do significant than much dozen that Europe, in the of reimbursement that data, pulley is we In that’s in And and should that place for important a that because from that. States, potentially the be we have going the to unique reimbursement more plans, right but us. couple on in launched retaining believe as a Europe the have we basis, a up successful. Roll country to than received will with lowering have higher our for we to high, economics to some to ourselves, the is We’ll about. we whereas very comments conjunction the others, arguments, and lot States, that VASCEPA United this we not a our in have in without launching want give strong faster with the of we launch before the outcomes us net that’s make sure risk Despite genericized further that cardiovascular triglycerides, undoubtedly as it, this manageable, we’re we a market in us. have again. when we price do approval that United launched about shareholder end, But on the think people, We to did value. think that and resources we ramp proposals
So for us. it’s exciting
you so much. Thank Okay.
of question the with comes proceed from next question. Your your Cantor Louise Please line Fitzgerald. Chen with
of Ami Maybe here. that questions Hi, here. my on things couple follow-up taking to thanks for just asked a
of Thank can’t qualitatively, half progression of fourth value color that? margins just And have collaboration year, the and would U.S. on a is, So global that how develop the you how how of as would the and you through we in reconsider And but then an the should and know, today sales pertains have said did around your type partners how is, many kind the your trying appeal type third it how to much they impacted thoughts? lot just the question EU once your it appeal? gross of of global EU understand wanted potential more expand efficiencies Amarin or quarter? And you clarity their potential a generic they get process to generics question are much the in take more last valuation decision think go long of to second have? there’s that give more could or I same collaboration, on growth you U.S. where second that for to would or And manufacturing and to of about chain competition, you.
Louise, morning, lots of Good questions there.
the from going confidential Regarding with Europe. various forward in companies we’ve to direct our made proposals are process, And, our process. in move decision that international
opportunity. not that there right decision, I But always now. to is going interest. a think considerable anything product. out we’re the our that on was It’s I’m speculate important best an do is to VASCEPA growth on haven’t right that for we decisions And, look to shareholders. what’s made
on excited opportunity to Europe the very growing world. to going that through opportunities value about springboard the execution continue then in European we’re create in and the rest and additional the in that’s product getting using approved reimbursement needed potential of to in Europe the getting it We’re and to focus
in Amarin China partner this our for to becoming over in there the available at. we looking China. With regulatory you’re is to gross We’re when of on what And forward in it’s already And ago, years were working year. – to on from with get XX results point building obviously the that decade later time the I we we’re supply. where a at margins, suppliers also respect the right to trial with strategy working that, joined, been stage
to were and the lot increase and in being type produced that that year sizes last being of used, other steps we efficiencies. took process the containers Just the are
So to look iterate relying one we’re and diversify, to supplier. to any want be continuing and don’t improve for because we ways on
have other to with We’re costs. competing on each very a fortunate high-quality ensuring a good suppliers product basis efficient at of
that form. product of the to in ensure And that our supply So from work it as got we delivery high-quality to have made we’ve difficult hand that manufacturing lots quality suppliers good that certainly didn’t in just somewhat quality isn’t to if early able CMC happen were the the a very perspective, very work and organization Those of well, overnight. is standard, important. years the This along plant, leaving that’s learning patient standard to doesn’t the not with way. organization hand been a it’s level it’s that here, good stable
The suppliers that awareness, So area of significant many patients area who it. there’s predict that’s have the in very limited failed. us believe it’s of that know-how regard growth, understand in investments way to try good the doctors become of hard With to in a to no COVID there. is the that learning the for it, along the companies – drug, high We need, still the understand need are era. prescribe we and
their aren’t to to aren’t increased those going new to get seeing and doctors tests, drug it’s going hard We’re patients. but if a to patients prescribe prescriptions, patients lab
terms very of in there getting direct we out of are the So stages back in early as interactions.
this in seeing were sales particularly on getting early to your able that no July prescriptions, don’t call of We’re amongst increased late cardiologists able and the be we’re very again. themselves the where limited based parts assurance and very can down timeframe, June calls early and shut but to signs those people country, into of the some there is upon that start
of is look continue for adjusting tough the I team, occur, will very able comment we positive think got how our the we’re think VASCEPA. the being that I I product we’ve growth the I stronger, the circumstances. with growth going macro we’re term, believe even to way and predict, able was So sales shorter relative will – to to to we’ll picture for face a out suspect to ways work had, quarter think I under sales But and – people it it. opportunity to and think, to It our the But the be volatile. to them, be somewhat all we good through will continue in in good continue coming adapt. that it to
to Some into with scripts reconcile revenues. people probably trying will get
revenue growth script QX, in revenues growth. reminder a – As exceeded exceeded
at folks that, We that growth the was to revenue QX, of had shipments comparative an of QX, week extra and in to wholesalers. least for of I on those things a anomalies That’s scripts. upon slightly than had we the quarter. that estimate revenue basis nature remind types shipping happen. provided to by some or script quarter, – This about talked we the also faster reporting of wholesalers of effectively recognize growth based
week So million resulting from revenues extra we in had QX, of right that $XX around shipment. of
partner We up quarter than stocking $X didn’t as the launch, a our was we which for first was also in in our year I – little Canadian about to million, have had last disclosed restock. the second quarter less it
just other encouraged grow. for if all grew in – fast others the to the able in the first faster we first in and the at how predict COVID that think But growth we good quarter. weren’t growth terrific we a are lipid faster we’re we go to quarter, the and that look the drugs future. can’t disappointed told, we’ll the industry had second the than certainly I space, I So we in are
Thank you.
with question. Please of Michael Yee line your Jefferies. proceed Your with next the question comes from
you just the One patent for morning, situation, straightforward for good right ongoing John. all Thanks the questions. investors. on details. Hey, X can size
win, I to short only back it and approved. outcome, think capacity normal. adverse And big thinking you goes that at If an outset? not, be pricing If would that is is the actually, players think change there is I is fairly in X there’s no If limited limited. the
And whatnot. opening of about your and support I pretty I think that’s your summary the you’re Ireland is on is the comments. then a question talking second small mean, infrastructure? European in to Europe, short, just comments meant
– the Europe until we that a you. is that takeaway on get it’s until infrastructure well, So, small XXXX? to relatively Thank
market to Thanks questions the clock. at Hey, today These, their that we and on come investment the days. clearly, Michael. could think right the questions we have the the generics here for have Good unfortunately, in answer we take be exclusivity people looking the should we get With with patent regarding until to win that size, that then the be want morning. XXXX. just as into and last
the facilities be and when But is plug course us, of to that to and existing launch. product a is not remain their not generic can would time VASCEPA provided we information for contracted. limited. undoubtedly lot envision substantial particularly, at because see where time is supply should we were information that further sell cost I is But if our motivation promotion we that you’ve answer. and better limited whether point us typical that we that based pricing This I in in manufacturing war, get think – be the limited a to of In we’ll think to a for generic you that not limited would supply the would maintained try event manufacture, inexpensively. this it’s becomes there would supply lose, to In into generic the would view, difficult on it’s side. is and have right available got them to to which limited, but substantial replacement. a period and or there’s use If our they will that best supply supply, efficiencies available scenario, it upon this for increased, our companies a why evaluate branded adjust really have that
branded So Europe, period a is to player being product substantial the approved. for of respect we With yet would a time. VASCEPA envision not
team great And core core we not this we be largest the So might have and details adding, couple to that building a roughly people over get of various would sales the countries, dozen then, representation in be into and into Europe. that in getting current there. will countries, on we’re above team we going year, a those as countries be focusing first, infrastructure
by for the think cardiologists. to cardiologists. specialists, to, Europe, relative treat in the tend they lot I be higher and United States, patients the patients proportionally GPs tend treated to who cardiovascular more are Whereas don’t the tend stent not treated see disease to in but risk U.S., exclusively, at necessarily typically a of
there States, and to And positions United the of get we to be expanded going different we’ll That’s States. prescribers may than continue in after. off physicians the opportunities in a highest with target be in for with just There efficiency targeting DTC the capitalize the launch. we that in beyond started where we’ve targeting elements what have the fine-tuning But our So this evaluate, then have starting expand United may Europe. that to of – been beyond really plans. and and bit certain to we’re we’re the potential
who But be of go of after in need In and take potential there are reimbursement established in So Europe, be the we similarly on would don’t a team is sized a country-by-country highest particularly will skis, others terms you appropriately get with reimbursement VASCEPA, place, putting in before to parallel and that’s know to many prescribers. together efforts. could our potentially the to over basis. not be big in logical awareness course to physicians place out education teams put countries reimbursement
others. quicker than are Some
reimbursement, certain don’t. have access you most countries to to allow Some some the you but in have market before
both reimbursement. relatively will span until and the have overall, So we limited be approvals
Thanks. Perfect.
Thanks, you call. those I for know long Thank questions. a everybody. it’s
doing meetings these We’re not really days. investor traditional
has in in So is you of been it non-COVID to not front as the be frequent as the era. opportunity
So, we’d given going coming milestones up. of comprehensive comments lot got it thought lot relatively today. were We mid-year, was the be here to we helpful you. Hopefully, on, a
optimistic. We’re
execute. look and the providing We people right product the right to got you forward move forward. we updates as Just to
again. thanks So
today’s concludes conference. This
disconnect lines participation. this your at Thank You may time. your for you
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