Amarin Corporation PLC (AMRN) 2012 Q3 法說會逐字稿

Greetings and welcome to the Amarin Corporation Third Quarter Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Steve Schultz, director of investor relations for Amarin Corporation. Thank you. Mr. Schultz, you may begin.

Welcome and thank you 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. Examples of such statements include but are not limited to -- our current expectations regarding regulatory filings; government agency decisions; potential indications and commercial success for our product candidates and approved product; our current expectations regarding the cardiovascular outcome study and the potential implications of such study on our regulatory process; plans to protect the commercial potential of our product candidates and approved product by obtaining patents and regulatory exclusivity maintaining trade secrets and taking advantage of manufacturing barriers to entry; our current expectations regarding a potential strategic collaborations; manufacturing efforts and preparation for commercialization of our product candidates and approved products; and our expectations for future publication and presentation of our study data; and our future expenses and the adequacy of our financial resources.

These statements are based on information available to us as of today, November 8, 2012. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements, and you should not place undue reliance on these statements. Actual results or events could differ materially. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions that we may enter into such as mergers, acquisitions, dispositions, joint ventures, or any material agreement that we may enter into or terminate.

For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-Looking Statements section in today's press release and the Risk Factors section of our most recent Form 10-Q, each of which were filed today with the SEC and are available on our website, amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin and not intended to promote the use of Amarin's Vascepa outside of its approved indication.

In addition, please note that these remarks will contain non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial measure most directly comparable to each non-GAAP financial measure used or discussed and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure can be found within our third quarter financial results press release. Finally, an archive of this call will be posted to the Amarin website in the Investor Relations section.

I will now turn the call over to Joe Zakrzewski, Chairman and Chief Executive Officer of Amarin.

Thank you, Steve, and welcome to everyone who is joining us today. During this call we will briefly review our recent accomplishments, update you on Amarin's financial performance in the third quarter of 2012 and answer a few questions from those on the call.

I am joined on today's call by John Thero, Amarin's President; Steve Ketchum, our President of R&D; Joe Kennedy, our General Counsel; and Fred Alholm, our VP of Finance.

Since our last quarter, we have advanced key objectives in a number of areas including FDA approval of Vascepa capsules as an adjunct diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia; eight patents, either issued or allowed within the United States patent and trademark office, in addition to over 30 US patent applications pending; receipt of an intention to grant of a European patent related to the MARINE Phase 3 trial findings.

While continuing to evaluate three paths to commercialization, an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third party support, continued preparedness for early Q1 2013 Vascepa launch including inventory purchases, managed care outreach, and management expansion; publication of ANCHOR Phase 3 trial results in the American Journal of Cardiology; the publication of additional MARINE Phase 3 trial results in the Journal of Clinical Lipidology; and most recently this week, presentation of Vascepa Phase 3 clinical data at the American Heart Association Scientific Sessions; received regulatory approval of Catalent as a second drug product encapsulator; and, as previously communicated, making good progress on REDUCE-IT enrollment, which continues to support the projected prescription drug user fee action dates for ANCHOR before the end of 2013.

While all these achievements are significant, we have done this while carefully managing our spending. As a result, we ended September with a cash balance of $215.1 million. As there may be some new investors on the call today, I'd remind you that on July 26, 2012, the scheduled PDUFA date, FDA approved Vascepa, which was formerly known as AMR-101, or what we referred to as MARINE indication. Use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, which is triglycerides greater than or equal to 500 mg/dl.

No adverse reactions were reported at the incidence level of 3%. In fact, only one incidence was slightly greater than placebo. That was for arthralgia, and that incidence rate was 2%.

It is this indication for Vascepa that will be launched early in the first quarter of 2013 while we work towards approval of additional indications for the product.

Since this approval, we have received a consistent flow of positive feedback from key opinion leaders and other clinicians regarding the Vascepa label. Clinicians clearly like the triglyceride-lowering effect of Vascepa without increasing LDLC. Many have commented, "If you don't have to raise LDLC why would you?"

Clinicians also commented on the broad spectrum of beneficial effects on the Vascepa label including Vascepa-attributed reductions in total cholesterol, non-HDLC, VLVLC, Apo B, LPPLDA2 as well as the safety profile that I just mentioned. Clinicians have also noted that the label for Vascepa does not include a warning regarding atrial fibrillation risk, which the FDA recently required of one of our likely competitors, Lovaza.

In addition to the above-mentioned comments from clinicians, we have often seen their interest level expressed directly through their actions. Recently, Amarin hosted or sponsored discussion about Vascepa and lipid management to overflow crowds in multiple venues. This has included presentations at specialty conferences, especially at the Cardiometabolic Health Care Conference held in Boston in October and continuing education medical programs sponsored in multiple cities. We also witnessed extensive tradeshow booth traffic at the American Heart Association's Annual Scientific Session this week in Los Angeles. These activities are beginning to introduce Vascepa to potential prescribing physicians, and they confirm Vascepa's huge potential.

Continuing with the regulatory update, we have drafted the sNDA for the ANCHOR indication -- that's the use of Vascepa to treat patients on statin therapy with multiple lipid disorders including triglyceride levels greater than 200 mg/dl. Our submission of this sNDA to FDA is pending only the final REDUCE-IT cardiovascular outcome study being deemed substantially underway as discussed with the FDA in connection with our ANCHOR special protocol assessment.

Patient enrollment in the REDUCE-IT study is progressing well and, as previously guided, we anticipate submitting this sNDA submission no later than the end of February 2013, which would position the sNDA for a PDUFA date in the fourth quarter of 2013.

In October, through a separate sNDA process, Amarin received the approval to use Catalent pharma solutions as a second Vascepa product encapsulator. As a result, we now have two FDA-approved encapsulators (inaudible) and Catalent. The diversification of our supply chain is part of our previously communicated strategy for supply chain risk mitigation for the use of multiple global suppliers.

Similarly, Amarin has agreements with multiple active pharmaceutical ingredient suppliers including Mission, the supplier approved as part of our NDA. Amarin has been working with Chemport NBASF for over a year, and we plan to submit sNDAs for both of these API suppliers around the end of this year.

In parallel with qualifying these additional suppliers, Mission has been steadily producing API, which will be used to stock various wholesalers in advance of the planned Vascepa launch.

Finally, we intend to submit a fourth supplier by the end of the first quarter of 2013.

Expanding on Vascepa exclusivity accomplishments, Amarin's patent strategy continues to gain significant traction. In the US Amarin now has eight patents either issued or allowed and over 30 additional patent applications being prosecuted. Of the eight patents, three cover the pharmaceutical composition of the drug, and five are specifically related to the MARINE indication. We continue to see our growing patent state as the most significant competitive advantage for Vascepa exclusivity.

We remain very encouraged by our progress as we continue to see timely patent office activity on additional, broader MARINE-related applications and, just as important, ANCHOR-related applications as well.

As previously announced, Amarin also received notification of an intention-to-grant letter for our primary MARINE method-of-use patent in Europe.

I remind you that Amarin's goal is to protect the commercial potential of Vascepa through exclusivity to beyond 2030 through a combination of patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry. Amarin has made great progress toward this goal, and we expect that progress to continue.

A decision remains overdue on the FDA's determination of five-year or three-year regulatory exclusivity for Vascepa. We continue to request that the FDA make a timely determination but cannot make a prediction as to when that determination will be made.

We believe that there are strong arguments to support five-year regulatory exclusivity of Vascepa as a new chemical entity under the provisions of the Hatch-Waxman Act, however, we cannot make assurances that the FDA will agree with our arguments or provide us with this five years of exclusivity.

Regarding Vascepa commercialization, as is expected for a biopharma company at our stage, Amarin is actively considering three potential paths to the commercial success for Vascepa -- an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter which could include third-party support. We will continue to closely evaluate each of these paths as we seek to maximize value for our shareholders.

Regarding opportunities with large pharma companies, the uncertainty around our pending regulatory exclusivity request has presented a challenge in our discussions. Whether we receive five years or three years of exclusivity, a decision in and of itself would provide some degree of clarification for many of the parties involved.

However, with our current coverage from patents with terms that expire in 2030 and beyond, and expanded additional claims now in prosecution, we continue to see our expanding patent prosecution as the most significant factor in protecting the Vascepa franchise in the long term.

Importantly, we also remind you the differences we expect competitors to face as they seek to securely supply highly purified EPA to compete with Vascepa and the potential protection afforded by our trade secrets and the leveraging of manufacturing barriers to entry.

Consistent with our three-option strategy -- an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support -- Amarin continues to anticipate commercial launch of Vascepa early in the first quarter of 2013, and we are taking all the steps necessary and required to enable a successful launch.

We believe that Vascepa, based on its demonstrated product profile is positioned to compete effectively with current therapies and those that are under development. Our goal is not simply to take market share, which we believe we can do successfully, but to expand the market well beyond current levels.

The indication for which we are approved represents a large and clinically important market as approximately 4 million, or 1 in 50 adult Americans have triglyceride levels greater than 500 mg/dl. This is a target market of specialty physicians that we believe can be successfully addressed by Amarin if the option is acquired with 250 to 300 sales reps.

The indication study in the ANCHOR trial represents a significantly larger opportunity, as approximately 40 million, or 1 in 5 adult Americans in the US have triglyceride levels greater than 200 mg/dl, and this represents a broader, more challenging primary care market. We feel that success in this population will require help from the outside.

Regarding both of those indications, we believe that our clinical results position Vascepa to be highly competitive commercially in both of these patient populations.

As of this conference call, Amarin has not made a decision to hire its own salesforce. As previously discussed, this decision would be made to start making offers to prospective sales representatives sometime between the middle of November and the end of November 2012.

Beyond the hiring of a salesforce, Amarin has done everything in its power to make Vascepa a successful launch regardless of which of the three options are pursued including bringing on key personnel in the areas of managed care, marketing, sales infrastructure, pricing, and supply, just to name a few.

I'll now ask Fred Alholm, Amarin's Vice of Finance, to comment on Amarin's third quarter 2012 financial results. Fred?

Thank you, Joe. As noted, earlier today Amarin filed its quarterly report on Form 10-Q with the SEC for the three and nine months ended September 30, 2012. While I'll provide some comments here regarding our financial results, you'll find a more detailed discussion of our results in the 10-Q.

Amarin reported cash and cash equivalents of approximately $215.1 million at September 30th, a decrease of $35.2 million from our reported $250.3 million in cash and cash equivalents at June 30, 2012. This increase in cash outflows reflects increased activities related to our commercial preparations for the launch of Vascepa. As of September 30, 2012, post-approval purchases of commercial supply were approximately $9 million as we begin to build up Vascepa inventory levels to stock wholesalers at launch.

As described last quarter, we anticipate spending an additional $20 million to $30 million for commercial supply prior to the launch of Vascepa in early 2013.

Our cash outflows in Q3 2012 also included expenses incurred for the REDUCE-IT cardiovascular outcome study of approximately $8.3 million, which commenced at the end of 2011 and has been accelerating throughout 2012.

The Company's liabilities as of September 30, 2012, excluding the value of the noncash financial derivatives, totaled approximately $164 million, which includes $130.8 million for the carrying value of the exchangeable debt.

Our research and development expenses for Q3 were approximately $19.9 million, excluding noncash costs associated with stock and warrant-based compensation as compared to $5.6 million for the same period of 2011. Our research and development costs in Q3 2012, in addition to REDUCE-IT and other development program costs, include the $5.7 million in costs for some purchases of pre-approval commercial supply and supplier qualification costs.

Prior to FDA approval of Vascepa in July 2012, all purchases of commercial supply were expensed as a component of research and development expense.

Our marketing and general and administrative expenses for Q3 were approximately $10.9 million, excluding noncash costs (inaudible) stock and warrant-based compensation as compared to $4.5 million for the same period of 2011. The increase is due primarily to cost increases for market research and education activities as well as higher staffing levels and other general and administrative costs incurred in order to prepare for the commercialization of Vascepa.

That concludes my prepared comments. I will now turn the call back to Joe. Joe.

Thanks, Fred. We are pleased with the progress that Amarin has made over the past quarter, especially regarding the expansion of Vascepa intellectual property coverage. In addition to news that could result from our continued strategic discussions, you may hear from us on the following in the near future -- regulatory exclusivity determination, REDUCE-IT cardiovascular outcome study becoming substantially underway, Vascepa sNDA submission for the high triglyceride indications needed in the ANCHOR trial, sNDA submissions for our expanded supply chain, additional grant of patents or notices of allowance, further strengthening Vascepa's proprietary position to at least 2030 and beyond, the commencement and completion of a Phase 1 PK study of a combination product comprised of Vascepa and a leading statin and, of course, the finalization of our Vascepa commercial launch plans under one of the three options we have previously discussed.

As has been the case, Amarin will continue to evaluate and pursue what, in our view, are the best options to maximize the value of Vascepa.

Thank you for your interest in Amarin. I would like to now open the call for a few questions. Operator?

Thank you (Operator Instructions) Chris Schott, JP Morgan.

Hi, guys, this is Dewey Steadman for Chris Schott. I just had a quick question on a competitor. One of your competitors was out this week with data for its Omega 3 product, and they commented that the Vascepa results may be aided somewhat by the use of mineral oil as a placebo in the MARINE and ANCHOR studies. And can you just comment on the rationale on the use of mineral oil instead of olive oil like the competitor or corn oil like the studies for Lovaza? And do you see your placebo choice as a marketing burden heading into the launch?

Thanks, Dewey. This is Joe. The FDA, through our FDA's approved our placebo, and over the years many companies have used olive oil, corn oil, mineral oil. We really think it's much ado about nothing. So we really don't see a difference.

What I think is more important to look at, though, is that we can actually look at the data that was presented on Monday, it was actually worse than the data that our competitor originally presented earlier in the year, i.e., their ANCHOR data was worse than their MARINE-equivalent data. What do I mean? On LDL they increased statistically significant, 5% at the 2 gram dose, and at 1% failed the non-inferiority study -- this is on their ANCHOR equivalent study.

If you recall, we reduced ours by 6% statistically significant. This is going to be a real problem for them beginning -- I'm not the FDA, but I know RELIANT had results better than that and failed to get their indication approved.

Their non-HDL-lowering is a third to half of what we're doing. They continue to talk about 5% to 7% dropout in their study just due to side effects. Just to remind you, we had zero percent in our MARINE study, we had 2% in our ANCHOR study, which was less than placebo. They wouldn't talk about what's going on regarding the side-effect profile. And then they've got lower LPPLA2 results and actually increased Apo B, where we decrease it.

I think the challenges are going to be there for them. I really look forward to the other competitors that are out there that we'll deal with when we hit the marketplace. They've also got patent challenges. I understand the US PTO has turned over one of their patents or is in the process. And with blind-name patents that we've got, it's going to be hard for them.

And then, finally, on NCE, I hope we get it. I think we deserve it. But their drug, in our opinion, is basically Lovaza. And so, really, a long answer to your question -- I think it's much ado about nothing, but, thank you, Dewey, as always, for your question.

Thomas Wei, Jefferies & Company.

I just wanted to ask a little bit about the commercialization strategy. Maybe a little bit more commentary about what you said about three versus five years of exclusivity and how that provides a degree of clarification for prospective pharma acquirers. Should we interpret that to mean that that's a really critical factor, and they're looking for five years of regulatory exclusivity? And then also a separate question -- if an acquisition cannot be consummated, what are some of the factors you're weighing when considering the other two pathways -- the pharma partnership versus selling it on your own?

Sure, thanks, Thomas. Look, we believe in our hearts that it's all about the patents, okay? Regulatory exclusivity, we'd like it as well, the five years versus the three, and we've got the trade secrets and then our ability to take advantage of manufacturing barriers to entry.

But, clearly, I think the position we're in all on the regulatory exclusivity is we'd like to have a yes answer. Second, we'd like to have a no answer, and, third, is sort of in the state we're at with an indeterminate answer.

In terms of what that means, I think everyone we're talking to really gets this about the patents, but like anything else, you go into a situation where you're building consensus in a big company, some of these organizations have different risk profiles, and although I want to believe that everyone believes that it's all about the patents, it is our potential fear that what happens if there's a no answer -- does the stock move and what does that mean within the Company and how they're trying to manage it. So I just think it's a lack of clarity, it's an overhang, but it's really about the patents.

In terms of the other two scenarios, as I said on the call, I said in the remarks, we have been parallel processing all of these, and we continue to build all the right infrastructure, all the right teams, everything we need. And our last step, really, is to make the decision to make salesforce offers. Just to give you a sense -- we've been approached by over 2,000 sales reps, okay, in terms of potential opportunities here at the Company. And we think that this is a great job, regardless of what happens. And, again, we've not made a decision -- so that's one.

And then the other alternative is what kind of partnership might you go with? We believe that it's got to be a very special partnership here, right? You can't do a deal that is a sale of a company by another means. What do I mean? You can't just take an up-front, milestones, and kind of royalty and then ultimately put yourself on a situation when you've tied the asset up for many years. If it's a partnership, it's got to be freedom to operate; freedom to do what we see, okay? And I think there are a lot of those that can still be possible.

And, again, as we said today, we're still pursuing the three options. We've not made a decision on making the offers on the salesforce. We take this very seriously on all three options, Thomas, and we'll keep everyone posted as we proceed.

Thank you. Joseph Schwartz, Leerink Swann.

I was wondering, are these exclusive agreements that you have with the suppliers, particularly for the API?

Yes, they all have some degree of exclusivity to them that would make it well below our percentage composition, okay? Could a supplier make DHA or a low-grade material, something of that nature, but they are exclusive to us. We've not announced the exact exclusivity but we feel very, very comfortable with the three that we have in place and the fourth one that we're about to put in place and covering us on exclusivity, Joe.

Okay. And then as far as your combination -- product development -- how do you anticipate co-formulating with a statin when your drug is given twice a day, and I think all the statins are once a day.

Yes, well, they're actually not, and some of them are approved in different regards. But we are working closely with the FDA in how we propose doing that, but there are exceptions to that, and we have our proprietary formulation that we're working on. And, again, as we previously stated, we hope to begin that study very shortly.

And then one more, if I could -- you said that if you were to hire a salesforce now that would be before the end of this month, and usually the NCE determinations are given in the the second full week of a month, which is next week, but you also said that lack of NCE clarity has presented a challenging discussion. So are you basically going to be deciding what you want to be doing, going forward with the Company, in the third and fourth week of this month?

Yes, I think what we've said is we're going to make a decision on whether we're going to start making offers to the sales reps sometime between the middle of the month and the end of the month.

In terms of what we're going to do with the Company, regardless if we start building the salesforce, I don't think anyone should think that once you build a salesforce, a, you're launching yourself or you've eliminated the other two options. I think we will constantly be in a path of always looking at are you launching yourself with help? Are you selling the company? Are you looking at a strategic partnership?

So I think the big difference is up to that point all three options are the same. It's when you start making those offers that you sort of do something different, but it doesn't take away the optionality where you might go.

Ritu Baral, Canaccord.

Joe, if we could go back to that salesforce hiring for a second -- what exactly are the timelines that you think that you would need to hold to in order to get your feet on the ground in Q1 as promised optimally? Would you -- if you issued the offers, how long would you need to train them and actually get them out there to launch the drug in Q1? Is this a decision that you could even push past to December? Or is it something that you feel that you would have to do in November for the sake of holding that Q1 deadline?

Yes, I guess there's always the possibility, Ritu, but the way we sort of look at this is that -- as I mentioned, we're approaching 2,000 resumes, if you will. The one thing I can tell you that's incredibly helpful to us if we go in this direction, and while we've been able to delay the decision to begin with that I originally said was October, is that there's been a huge concentration of sales reps over the past two years -- or adoptions in the US. They've gone from 110,00 to 115,000 down to 65,000.

And of those 65,000, we really have our pick of the litter, so that I can tell you that as we look at the 200, 250-plus territories we're going to have, I can tell you that everyone we might hire, might hire, has experience in the cardiometabolism diabetes space with those very physicians we'll be promoting to.

So instead of doing what we did in my former job at Reliant or otherwise, where you might go hire people out of school or from T-Mobile or at the mall, and that's what a lot of people used to do. You're going to get folks with three to 10 years' experience with the very doctors you want to go in and promote to. And what that allows us to do is make the decision to offering, let's call it mid to late November, bring people want to work mid to late December, train, and then go into a launch mode.

I will tell you that when we look at the folks that are out there and even a lot of the folks that we've talked to -- they know this space. They know our product, and we're in a very fortunate position to have this great product with many great people available. I think we can really make that happen.

But if we do make that decision to do it, we're taking this very, very seriously, okay, and I'll just leave it at that.

And a second question -- as you go through your talks with potential business development partners, are they looking at the market the same way that you are? Are they looking at the same sort of numbers of patients both in the 500-plus and the 200 to 500? Is there any sort of points of discussion or alternate points of view in certain areas?

Yes, I would say that it's always hard for me to tell you how people are thinking about these things. I would tell you that everybody looks at MARINE as being a huge opportunity, and an ability to expand the market and still share, if you will. An ANCHOR is something more of an untouched opportunity. So -- I think across the board people get it. To what degree they get, and how things go of that nature, ultimately that's for them to answer. But I think it's safe to say that people see this as a very, very significant opportunity.

Do they see NCE as narrowing to one market more than the other?

I think what I'd like to believe is that it's all about the patents, and people are evolving and have gotten to that point. I think the issue -- and, again, these are always very subtle things. I think the NCE piece is an overhang, and I think that's really the issue we're dealing with. And as I said, our priority would be to have a yes decision on NCE, our second would be a no decision, and our third would be -- a no answer -- and our third would be sort of where we are today -- waiting. It's just tough, you know?

Brian Rockowitz, Aegis Capital.

How are you, Joe? Congratulations to you and your team on a successful FDA approval of that drug.

Thank you.

I'm just going to bundle my questions into one. I want to reference an article that was dated January 11 in Bloomberg News, where you were interviewed, and you had said that you had seen more interest from potential partners and buyers. You've had more companies interested in this asset than employees, and at the time you had 17 employees on the payroll.

The second thing is -- well, my question is are you still getting that kind of interest from interested parties? The second one references an article in The Daily Mail about two weeks ago where they suggested that AstraZeneca had a possible interest in your company. And the last question, I guess, goes back to your days as Chief Operating Officer over at Reliant when they were sold to GlaxoSmithKline. I guess, on a personal level, have you learned anything from that experience that you feel better positions Amarin, going forward, in today's market?

Well, thanks for the questions. First of all, regarding the Bloomberg article for 2011 early. We all live and we learn in what we say and what we don't say. I could tell you that we continue to see significant interest across the board. I can officially tell you today we have more employees as we approach approximately 100 than we have potential interested parties -- high intended but, you know, you go down this process, and you've got this incredibly valuable asset that we're sitting on right now.

You've got pharma companies out there spending $3 billion to $5 billion a year on R&D, and that's launching one drug. So I think people get how special this is, and we really continue to make the progress. But they sometimes take longer than they do, but I can confirm things are still very active.

On your second question about The Daily Mail and AstraZeneca, I have to officially say no comment. There's been speculation for quite some time, and we'll leave it at that. And I think the Reliant experience has been incredibly valuable to me personally, I think to the Company, and folks around -- I'm sitting here with Steve Ketchum, who is the Chief Scientific Officer, and I think we learned a lot. I think the one thing we know -- or we believe -- is when we look at the data that we have and compare it to what else is out there, this is a very, very special product.

I think you can learn a lot just by talking about -- I'll give you an example. We've also got Joe [Jabouli] and his team driving the pricing strategy. He was with us at Reliant. He was responsible, he and his team, for capturing 200 million lives in managed care and reimbursement. We've been out, and we've talked to every major company out there from a reimbursement perspective. We think we're pretty well positioned there.

We've got supply expertise, we've got pricing expertise, we've got marketing expertise, and alternately, if we need it, we'll do the sales expertise. Again, I think the most important thing is this is a special asset and a very special period of time with a very special team managing it. And we're incredibly motivated here and excited about the opportunity regardless of the which of the three paths we go down.

Well, I want to thank you. You guys are doing a great job, and that finishes my line of questioning.

Thank you very much.

Ladies and gentlemen, we have reached the end of our Q&A session. I would like to turn the floor back over to management for any closing comments.

Thank you. Look, everybody, we're delighted. I'm told there were 500 people on the call today. A great turnout. We continue to work diligently to maximize the value of Vascepa, and we're going to continue to do that. We've got some exciting times continued ahead here in reference to some of the decisions we have forthcoming. Again, looking for further clarity from the regulatory agencies regarding this "overhang." And there are really great things going on with the REDUCE-IT study, the submission of ANCHOR and, really, across the board, just a real team pulling together here.

So we thank you for your commitment. I know I'll be talking to many of you over the next several days, and we just wish you a good evening. Thank you.

Thank you. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.