Greetings, and welcome to the Amarin Pharmaceuticals Fourth Quarter and Year End 2013 Results and Update on Operations Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Joe Bruno, Director of Investor Relations for Amarin Pharmaceuticals. Thank you. 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 financial performance, including levels of expenditures and revenues, supply-related activities and the adequacy of our financial resources; our current expectations regarding regulatory filings; government agency decisions and potential indications; our current expectations regarding our cardiovascular outcome study and the potential implications of such study on our regulatory processes; plans to protect the commercial potential of our product candidates and approved product through patents, regulatory exclusivity, trade secrets and existing manufacturing barriers to entry; and our current expectations regarding potential strategic collaborations. These statements are based on information available to us today, February 27, 2014. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements, so 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 we may enter into such as mergers, acquisitions, dispositions, joint ventures or any material agreement that we may enter into, amend 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-K, 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 is not intended to promote the use of Amarin's Vascepa outside its approved indication. Finally, an archive of this call will be posted on the Amarin website in the Investor Relations section. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Thank you, everyone, for joining us today. With me on today's call from Amarin are Steve Ketchum, our Vice President of R&D; Joe Kennedy, our Senior Vice President and General Counsel; Aaron Berg, our Senior Vice President of Marketing and Sales; Mike Farrell, our Controller; and Joe Bruno, our Director of Investor Relations. During today's call, we will review Amarin's recent commercial and operational performance and financial results for the fourth quarter of 2013. I will summarize our highlights and achievements and then ask Aaron Berg to provide you with a commercial update. Following Aaron, Mike Farrell will review Amarin's financial performance. I then will cover various other matters, including a brief update on our regulatory situation regarding the ANCHOR indication, before fielding questions from analysts and investors as time permits. While the fourth quarter of 2013 included the disappointment of not receiving approval for the ANCHOR indication, we made progress in numerous other areas. Since our last quarterly earnings call, Amarin drove total prescriptions in Q4 2013 for Vascepa, higher from the prior quarter, despite the 50% reduction in staffing of our sales team that we announced in October. The 2 leading independent sources of script data are Symphony Health, which estimated approximately 91,000 normalized Vascepa scripts in Q4; and IMS, which estimated approximately 80,000 Vascepa scripts in Q4. The variance between these independent sources reflects that accurate estimates are difficult to establish in the first year of a launch. Also, in Q4, we grew our prescriber base for Vascepa to over 16,000 physicians, improved our managed care physician, increasing the number of Tier 2 lives covered to 100 million, exceeding 2/3 of the level of Tier 2 coverage which has been achieved over multiple years by comparative therapies and reflecting the strong clinical and safety profile of Vascepa.…

Thank you, John. I and the balance of our sales and marketing team are confident that 2014 will be a positive year for Amarin and Vascepa. We have a terrific product and great people. While our team today is smaller than it was in October, it's of sufficient size and efficiently aligned to drive prescription growth. We have shifted from a primary care sales force model, which called on a broader group of physician targets, to one that's highly focused on a smaller group of the highest potential prescribers. We believe, as supported by data, that repeat calls to these high-value prescribers will generate increases in prescription growth, particularly as the prescribers continue to witness positive patient results and as they get increasingly comfortable with favorable formulary coverage for Vascepa. As you may be aware, I was in a similar position as Amarin is today in the early days with Kos Pharmaceuticals after the launch of Niaspan. We had a similar size sales force presence, and over time, physicians became more and more comfortable with the drug, leading to script growth acceleration. Revenues for the product, while starting low in the early years post-launch, began to grow more rapidly over time until we built a $0.5 billion franchise. From a sales perspective, we had a better first year in the launch of Vascepa than did Kos with Niaspan and this is particularly true when taking into account the more challenging managed care environment today. We've only just begun our second year of Vascepa sales. In addition to adopting a more efficient, focused sales model, with high-frequency focus on top potential prescribers, other changes in 2014 include fine-tuning our messaging and leveraging strong and growing Tier 2 formulary coverage, together with targeted, non-personal promotional outreach, peer-to-peer speaker programs and targeted product…

Thank you, Aaron. I will provide some commentary regarding our financial results. You will find a more detailed discussion of our results in our 10-K and press release issued earlier today. We reported net product revenues for the quarter and year-to-date period ended December 31, 2013 of $10.1 million and $26.4 million, respectively. Cash collections from the sale of Vascepa in the fourth quarter of 2013 were approximately $13.2 million, for a total of $31.7 million collected from wholesalers since the launch of Vascepa. As has been previously discussed, our revenues have been recorded based on the sell-through method, and our gross to net price adjustments include certain launch year-related factors, which resulted in a lower net price per capsule than the approximately $1.25 net price per capsule that we anticipate achieving over time. Such net pricing factors in a number of customary and launch-related adjustments, including discounts to wholesalers to stock Vascepa prior to launch and high levels of utilization of co-pay cards as we continue to improve our coverage, converting higher-tiered plans to Tier 2 status for Vascepa. Some of these launch-related discounts will not be a factor in future periods. We increased our wholesale pricing 6% in December to a price of $195 for a bottle of 120 Vascepa capsules. And recently, in 2014, we lowered patient co-pay amounts under our co-pay card program to $9 from $25 to mirror a similar change made by a competitive prescription product. We expect that Vascepa revenues will continue to grow in 2014. The extent of such growth depends on the effectiveness of our commercialization progress, as well as external factors such as whether or not we gain approval from the FDA to market the favorable results from the ANCHOR trial, and the extent to which new competition is effectively…

Thank you, Mike and Aaron. As Aaron pointed out, we have a focused strategy for 2014, and we believe that we will be able to increase Vascepa sales and revenues within our existing sales structure. That said, we continue to review other opportunities such as x U.S. markets for Vascepa, as well as co-promotion opportunities here in the United States. With regard to securing the ANCHOR indication for Vascepa, as expressed previously, we believe that we have strong legal, regulatory and clinical arguments. However, it is clear to us that this is an uphill battle. We are pursuing both a reinstatement of the ANCHOR trial SPA agreement and approval of the sNDA for the ANCHOR indication. The appeal process within the FDA can be lengthy, and there can be no assurance that we would be successful. Based upon information available to us, we do not believe that the FDA's review decision will take negative action on the ANCHOR sNDA during this time, while we are appealing the SPA recision decision within the office level at FDA. We believe in the science behind the ANCHOR study and are confident that the addition of the ANCHOR indication to the currently approved label for Vascepa is in the best interest of both physicians and their patients. As reported in January, we anticipate that it won't be until sometime in Q2 or Q3 before we reach the level within the FDA that we initially targeted in our appeal in early November. While it is always possible that the FDA responds favorably before that time frame, we cannot now predict whether the FDA will act in a timely manner, and we do not have visibility into the FDA's internal deliberations. We do not plan to provide further updates on this matter until such time as there is a substantial change in the status. With that, I'd like to open the line to some questions. Operator?

[Operator Instructions] Our first question is coming from the line of Mr. Thomas Wei with Jefferies.

I had a couple of questions. The first is just on a housekeeping thing on revenue per pill. Just some help on what exactly was the gross to net adjustment during the fourth quarter and how to think about that for 2014. And then also, when you talk about cash use in 2014 and not needing to go back for further financings, I wanted to get a better understanding of how you think about sales growth from here. Is it a resumption of growth that was -- that's in line with the pre-4Q levels? How should I think about that?

Thomas, this is John. Regarding your first question on revenues per capsule in the fourth quarter, roughly the same as what we had in the third quarter, few pluses here, minuses there, but roughly the same. As Mike Farrell had commented, in the December time frame, we did increase the lack price of our product by 6%. However, here in the first quarter, we have reduced the co-pay card from $25 co-payment to $9, which have given the proportion of people who use our co-pay card, which is a bit higher than what the industry standard is. Those 2 amounts roughly offset each other. So there are some other trends that it may hopefully improve the net revenue per capsule during 2014. But regarding the primary question, essentially the same number quarter-to-quarter, Q3 to Q4, and the 2 big pieces of price increase in co-pay card roughly offset each other on a per capsule basis. With respect to cash, we ended the year with a little over $190 million in cash. We anticipate through the various cost-cuttings that we've done that we'd make a significant dent in our cash burn from the cost-cutting side, the supply piece, the reduction in force by 50% being big contributors to that. We are anticipating that revenues will increase. While we've not quantified that, in order for us to achieve the $80 million in net cash burn, there is some assumption of revenues increases in that, but it's not at an extreme relative to that level of increase. We recognize that the product that we're selling here is a product that is for chronic use. That education, it takes time. We think that we're building success, as Aaron described. He's been through this at Kos. The continued blocking, tackling, utilizing the strong message that we have, building on the reimbursement that we have, we think, will all contribute to that. But the specific levels of revenue growth assumed, not prepared to describe, but for that $80 million cash number, it's not a huge jump in revenues assumed to get there.

And just -- I wanted to squeeze one in on the co-promotion comment and partnering comment that you made. Can you give us a little bit more color around that, how heavily you're weighting that? Does it change now that you've had a 3-year exclusivity decision from the FDA? How do you think about kind of corporate strategy going forward and that as an option?

Relative to the cash burn number that we've just described, if we were to get the ANCHOR indication approved, that would be additive or improvement upon that. And if we were to find a co-pay -- appropriate co-promotion partner, that ought to be an improvement to that as well. So it's not a co-promotion partner assumed in the cash burn, this is MARINE-only on our own number, which we're certainly looking to be opportunistic on in terms of improving against. The -- there is, particularly here, post the reduction force and look at what else might be out there relative to co-promotion partners. The -- we think that the specialty sales force model that we have in place right now, given the quality of people we have and the quality of our product, it provide us with significant opportunity for growth. We are evaluating whether it is possible to do something with the co-promote partner. Though with the significant difference that an approval of the ANCHOR indication could make, it is difficult, in many cases, to come to appropriate terms on what a deal structure could look like. So we are evaluating, but I -- also cautioning that, right now, the numbers we put forth are on a standalone basis.

Our next question is coming from the line of Mr. Jonathan Eckard with Citi.

And I apologize, I joined the call late, in case you addressed some of these. When I look at the operating loss for the fourth quarter and then I look at the guided cash usage for 2014 and then -- I'm just trying to think, how should we be thinking about the reduction of burn over the course of '14 that's going to get you to that profitability? Like what are the levers that we should be modeling to help us understand where you're going to get them? Is it going to be pure volume? Is it going to be improvement in cost of goods? I guess I'm trying to understand a little bit about how we should focus on the ramp to get to those levels.

Yes, I can provide some additional detail on that. So one of the pieces that we've talked about was supply. And in 2013, we spent over $25 million on supply. And for our MARINE-only indication, it's a level of supply that we have which, on our balance sheet, is, I think, greater than that amount. It's sufficient supply for the coming year. So we do have some minimum purchase requirements with various suppliers. Those requirements are less than what we had purchased last year. So there's a significant opportunity for us to reduce costs there. We have cut the size of our team in half. That has been previously announced. But if you were to sort of look at our selling and marketing expenses for last year, our total SG&A was about $124 million, the G&A piece of that, excluding noncash items, a little less than $15 million. So the big piece there is a little over $100 million in sales and marketing. That's people, and it was painful to let those people go. But the costs are directly related to the people, so we'll be spending roughly half in 2014 than what we spent in 2013. On the R&D side of things, in our 10-K, we provide a fairly significant breakdown of what our costs were for R&D during 2013, and those numbers add up to about $73 million. Now a big piece of that is REDUCE-IT between TTM [ph] costs and CRO costs that was nearly $47 million. There were some amendments made during the year. There were site enrollment going on, countries being brought up-to-speed, the -- and an awful lot of patients being enrolled during the year. So I hope this was our most expensive year within the REDUCE-IT program. We also had other R&D programs going on where we spent a couple of million dollars. One of those was the -- related to the fixed-dose combination with a statin. Well, without an ANCHOR indication approval, we have -- despite having encouraging feasibility results there, there's not a lot of need to progress that without the ANCHOR indication, so there's cost savings from that. We write a lot of regulatory fees in this past year, both for the sNDA for the ANCHOR indication, as well as for qualifying manufacturing sites. So there's roughly $20 million or so of savings that might be looked at as being a reasonable number on the R&D side year-to-year that one could pick up in terms of savings. So those are a few comments. Yes, there is assumptions of revenue growth year-to-year. There's assumptions of some continued margin improvement as well. But the big pieces are off of supply, off of the headcount reductions and off of some of the other cost savings initiatives that we put into place. So I hope that's helpful.

Our next question is coming from the line of John Boris with SunTrust.

On the 16,000 prescribers, can you maybe boil it down to patients? Total number of patients that you currently have on the drug, how many of those patients were new patients? And what percent of them were switched patients from other competitive therapies? Second question, John, on strategy. If you look at this very high prescriber base, they co-prescribe a significant number of other products. Have you evaluated possible co-promotion strategies that you might be able to sell another asset through your sales force to maximize the efficiency of the sales force? Third question on the SPA recision. 2Q, 3Q seems to be a long time to go through the FDA. Can you help us understand what are the next steps that you and your external consultants and lawyers need to do, along with the FDA, to bring this to resolution and bring it to the upper levels of FDA? And then lastly, just on REDUCE-IT, any thoughts on the size of the trial there and timing for completion and readout of results out of REDUCE-IT? There was some thought about having to possibly increase the size of that trial, but any thoughts you can give there would be appreciated.

Okay. Lots of questions there. I'm going to answer them in the order that probably have the most pithy answers first, and then I'll expand to the other ones. I will start with the last one, which is REDUCE-IT. We are over 6,500 patients enrolled. It's a trial that's designed around approximately 8,000 patients. We do, within the study design, have some internal guys that we're looking at relative to what the mix of patients in it at various different levels of baseline triglycerides we've talked about, and I think a couple of calls here in a row that the average baseline triglycerides in that trial is both mean and median, above 200 mg/dL. We had made a change in the protocol last year, as we felt as though we had enough patients within the lower strata of the trial enrolled baseline triglycerides level. We're really aiming for all patients going forward to be at above 200. We'll continue to monitor that. Right now, we would project, based upon the mix that we're seeing and the timing of enrollment, that enrollment would be completed somewhere in the first half of 2015. But it's certainly something that we're continuing to take a look at, both relative to that appropriate balance but also because this is an events-driven trial, what's the right mix in terms of getting to the endpoint as quickly as possible. In all of this, also, is our consideration of the fact that this trial is not inexpensive, just a little over $100 million of cost remaining here. And we are seeking additional clarity from FDA relative to the ANCHOR indication, which was assumed when we had entered into the SPA with FDA, that we'd be getting that label to help us fund the REDUCE-IT study. So we're continuing…

No, you covered it well.

I covered it. Relative to the topic of FDA and timing, let me -- Joe Kennedy, our General Counsel, is here, and he's intimate with that. Let me turn that over to him.

So as I understand your question, it essentially boils down to why it's going to take until Q2 to Q3 to get a response. So our process with FDA right now is governed by their guidance on formal dispute resolution. As most people on the phone know, we've gone to the division in a request for reconsideration on the SPA reinstatement, and we're rejected on that response. And the next set is to appeal up the ladder, and that dispute resolution process involves the opportunity to do that next to the Office of Drug Evaluation II. And then if that's not successful, office -- up to the Office of New Drugs, to see the Director and up ultimately to the Commissioner of FDA. So we're in that process right now. And as you can appreciate through the guidance, after reading it, that each step takes a set period of time under the guidelines, 30 days, or if there's a meeting, an additional 30 days on top of that for the FDA to respond. And as those who have followed us come to appreciate, FDA doesn't always meet those guidelines. We're not going to get into on this call exactly where we are within the process. But it does take some time to prepare appeals from each additional level that we hear back from FDA, for the FDA to respond. We've expressed a previous update on this, that the FDA was not very responsive on all the issues that we've raised in our prior response. So -- in our current document in to them, we've gone to great lengths to make sure that we've pressed them with very pointed questions that we expect will take some time for them to respond to. So we don't have a definitive answer for you on exactly when we're going to hear from FDA on a definitive response at a level which we expect to have FDA take into consideration not only the scientific arguments that were the focus at the division level but also the more policy-oriented arguments that are based upon the SPA program. And our issues really are convergence of those 2. So we expect though, based on our reasonable expectations and the guidance of our advisers who are at the top level of their profession in this area, that it would be probably Q2, Q3 before we get to a level within FDA that we expect to be able to take into consideration all those matters for us. I hope that answers your question.

Our next question is coming from the line of Gary Nachman with Goldman Sachs.

This is Roger Kumar stepping in for Gary. So I was just wondering, at what point would you guys have some better visibility into whether or not you want to continue on with REDUCE-IT? And I've got one more follow-up after that.

We are continuing to monitor that. Relative to achieving the ANCHOR indication, it is a requisite that we have the REDUCE-IT study. So while we are in a position that we believe that getting an expanded label is feasible, we certainly don't want to undermine that by pulling back unnecessarily on that study. Furthermore, it's a study that we scientifically believe in. We think it's a huge opportunity, and we think that we're positioned for success. But it is expensive. So we're continuing to monitor it. But while we are in a mode of interaction with FDA and trying to secure a broader indication, it doesn't make sense for us to do anything other than to proceed in the ordinary course. In parallel, we're evaluating different actions that might be taken in the event that we aren't able to secure that broader indication.

Our next question is coming from the line of Mr. Bert Hazlett with Roth Capital.

Covered a lot of ground today. My question has to do with pricing. You took a price increase, I think, on the WACC of 6%. You followed that with the co-pay decreases you've mentioned. How should we think about pricing going forward maybe in the near term and the longer term? I know that the experience with Kos that I had, in addition to others on this call, was one where not only did they have good, robust script increase, but it was complemented with robust price increases. I'd love to just get your thoughts there, again, near term and long term.

Yes, it's a good question. It's a competitive marketplace. We believe that we are well-differentiated. However, we're up against products that have been in the marketplace for quite a while. When we came -- when we're launching, we spent a lot of time evaluating what the price should be and spent some time considering whether we should be premium-pricing our product against what's out there because of the safety and efficacy of favorable differentiation. We decided that the right approach is parity pricing and, particularly, parity pricing with the most comparable product that's out there to us. They have been raising prices for the last couple of years, twice per year. We'll see what they continue to do there. The -- but I think parity pricing against Lovaza right now and battling it out with clinicians on the basis of safety and efficacy is how we're approaching things because we know that there's been, for years here, discussion of will there be a generic Lovaza that comes into the marketplace or not. Obviously, a generic Lovaza will have the same concerns relative to increases in LDL that the branded product has. And as we provide increasing education to clinicians and as the guidelines focus people more and more in LDL, they start thinking about particle counts and treating LDL first. We think that docs are thinking more about cause and effect, that, that's an advantage of going to continue to play to our favor. We also think that the -- if and when there is a generic Lovaza, that the nature of such a product, this is not a traditional type of a market for a generic. Purity at this level is not achieved inexpensively. You can't just take this to a normal API manufacturing site. There's investments to be made. So I think for the foreseeable future, even if there is a generic Lovaza earlier this year, we don't believe that any NDAs have been acted on relative to a generic Lovaza. But if and when one comes out, we think that their pricing is -- their pricing, their LDL increase in a limited capacity isn't going to cause us to have to change our pricing strategy in any significant way and will likely leave the branded product Lovaza as being our primary competition. I hope those comments are helpful.

Ladies and gentlemen, we have reached the end of our time allotment for questions and answers. I would now like to turn the floor back to management for any closing comments.

Folks, again, thanks for joining us here today. We think we're making considerable progress. We think we've turned the corner relative to the reorganization of our internal team. We're making inroads relative to script growth, particularly with the higher [indiscernible] targets that we're going after. And we're continuing to pursue our other priorities of cost control and expanded labeling for Vascepa. We look forward to continued updates and appreciate your support and interest. Thank you.

Thank you. Ladies and gentlemen, this does conclude this afternoon's teleconference. You may disconnect your lines at this time. Thank you very much for your participation.