Welcome to Amarin Corporation's conference call to discuss its financial and operating results for the first quarter of 2015. This conference is being recorded today, May 8, 2015. I would now like to turn the conference over to Mike Farrell, Vice President of Finance from Amarin. Please go ahead, sir.

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 our commercial and financial performance, including levels of Vascepa sales, revenues and other commercial metrics; expenditures, supply-related activities, managed care coverage and the adequacy of our financial resources; our current expectations regarding product development internationally, government agency decisions and pending litigation; our current expectations regarding our cardiovascular outcome study, such as anticipated enrollment, the related regulatory process and potential outcomes; our plan to protect the exclusivity and commercial potential of our product; and our current expectations regarding our co-promotion agreement and our business generally. These statements are based on information available to us today, May 8, 2015. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. 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 quarterly report on Form 10-Q for the quarter ended March 31, 2015. These documents have been filed with the SEC and are available through the Investor Relations section of our website at www.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 Vascepa outside of its approved indication. Finally, an archive of this call will be posted to the Amarin website in the Investor Relations section. In addition to myself, on today's call from Amarin are John Thero, our President and Chief Executive Officer; Steve Ketchum, our President of R&D; Joe Kennedy, our Senior Vice President and General Counsel; and Aaron Berg, our Senior Vice President of Marketing and Sales. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good morning. Thank you for joining us today. We have made an important progress thus far in 2015. On today's call, we will discuss Amarin's recent commercial, operational and financial performance, provide an update on company initiatives and then take questions from analysts and investors. Our priorities for 2015 remain unchanged: To support improved patient care with Vascepa; increase revenues; continue to execute on our cardiovascular outcomes study, REDUCE-IT; and to manage our business in an opportunistic and cost-effective manner. In the opportunistic category, one of the highlights of our Q1 2015 performance is our agreement with Eddingpharm for the commercialization of Vascepa in China. Our operating results in Q1 reflect both the receipt of the $15 million upfront payment, which is part of that agreement, and the recognition of a portion of that payment, approximately $400,000, in Q1 as licensing revenue. More important than this upfront payment is the large market opportunity for Vascepa in China and the commitment Eddingpharm is making to commercialization of Vascepa. Eddingpharm is experienced both in securing regulatory approvals for products in China and successively marketing products in China. As previously announced, the terms of our agreement with Eddingpharm include double-digit royalties to Amarin on Vascepa sales, costs plus product purchases in a range of potential additional regulatory and sales-based milestones totaling $154 million in aggregate. China was our top priority for commercialization of Vascepa outside the United States. We are increasingly, but selectively, assessing other partnership opportunities to commercialize Vascepa in other markets outside of the United States. It required more than 6 months to reach mutually acceptable terms with Eddingpharm. We cannot predict the timing or terms of other potential ex-U.S. commercialization agreements for Vascepa. In addition to the Eddingpharm agreement, our recent highlights include: Continued prescription growth for Vascepa, which Aaron…

Thank you, John. As John mentioned, we're pleased that Vascepa revenues grew significantly in Q1 compared to the same period of the prior year, but we are clearly seeking greater growth. Vascepa revenues and prescription growth in the first quarter of 2015 was impacted by the effects of severe winter weather throughout much of the U.S., as well as by beginning-of-the-calendar year healthcare plan issues, such as new year patient deductible amounts. The exact impact of weather events is difficult to quantify, given other market variables involved. However, it appears to have had a particularly significant impact on retail pharmacy prescriptions for drugs used to treat chronic conditions. Symphony Health identified 7 winter storms during early 2015 that negatively impacted retail total prescription volumes for the entire industry at the national level. Prescription activity was affected by one or more storms in 31 states and the District of Columbia. Based on Symphony Health total prescription data, prescriptions for other drugs were adversely affected as well, including statins and hypertensive agents and oral diabetes agents. The good news, which I'll get to, is that Vascepa prescriptions achieved record highs in March. For January, Symphony Health reported that prescriptions filled in the non-statin lipid market were down 7.2% from December. For February, Symphony Health reported that prescriptions in the non-statin lipid market were down 8.5% from the already low January levels. Vascepa prescriptions were also down in January and February, but not to the same extent. In March, based on Symphony Health data, Vascepa new prescriptions grew 14.1% over the December high, while Vascepa normalized total prescriptions rebounded in March to achieve 5% growth from Q1 overall versus Q4 of 2014 and 66% growth over Q1 2014. Vascepa prescription growth continues to be primarily generated for higher decile physicians targeted by both…

Thank you, Aaron. As John and Aaron noted, FDA's decision to not approve any form of our ANCHOR sNDA, which included a decision to not approve the addition of ANCHOR efficacy data in current Vascepa labeling, has created a real problem for the care of patients with persistently high triglycerides after statin therapy. Using drugs like Vascepa to treat these patients is commonplace in medical practice. Doctors choose to lower patients' lipid levels based on their own expert medical judgment and with guidance from multiple national and international treatment guidelines and physician statements. A decision to treat is filed by the need to decide among available treatment options. That decision is based on clinical data and scientific evidence known to the doctor. For the years before Vascepa was available, doctors treated these patients with fenofibrate and niacin products and then Lovaza, and of course, continue to do so. As Aaron explained, in late-April, contemporaneous with the issuance of our ANCHOR CRL, FDA withdrew indications and data from labeling of fenofibrate and niacin products related to the treatment of patients studied in the failed outcomes trials, ACCORD-Lipid from 2010 and AIM-HIGH from 2011. As additional information for investors, we've included in the Frequently Asked Questions section of our Investor Relations website an overview of Amarin and FDA's views on those studies, as well as on the HPS2-THRIVE study and on the JELIS cardiovascular outcomes trial of EPA in Japan, each as discussed publicly over time and, in particular, since FDA's October 2013 ANCHOR advisory committee meeting. Fenofibrate and niacin drugs are still widely used for treatment of patients with persistently high triglycerides, despite years ago, having failed in cardiovascular outcomes trials that included some patients with persistently high triglycerides. Similarly, Lovaza data in the high triglyceride, despite statin therapy patient population,…

Thank you, Joe. My comments will address our recent financial results. You will find a more detailed discussion of our results in our 10-Q and press release issued earlier today. In the first quarter of 2015, we recognized $15.6 million in net product revenues, representing an increase of 42% as compared to net revenues of $11 million in the first quarter of 2014. Net revenues in the first quarter of 2014 include approximately $1 million in previously deferred revenues related to a change in our revenue recognition methodology from the sell-through to the sell-in method. We also recognized $400,000 in licensing revenue from our China collaboration during the first quarter of 2015. As previously described, the timing of shipments to wholesalers vary from period to period. At the end of March, wholesalers held approximately 4 days fewer in inventory than they held at the end of December. We view this to be more of a matter of timing and not an ongoing trend. You may recall that during 2014, we commented that in some quarters, wholesalers increased inventory levels. And in other quarters, their inventory levels declined. The largest wholesalers purchase most of their product once per week, and smaller wholesalers sometimes purchase less frequently. Depending upon the timing of orders and the timing of shipments, their average inventory levels vary. Our average net price per capsule sold in the first quarter of 2015 was slightly lower than our average price in the fourth quarter of 2014 as a result of additional rebates due to expanded commercial coverage and improvement in formulary position, partially offset by the price increase implemented in mid-November 2014. For the first quarter of 2015, this resulted in a reduction in Vascepa product revenues of approximately $400,000. Our overall rebate levels remain consistent with industry practice,…

Thank you, Mike. Our key Amarin operational theme for the balance of 2015 is focus. We need to ensure that REDUCE-IT continues on track and prepare for the potential that REDUCE-IT could read out positively in 2016. While we are primarily operating on the assumption that REDUCE-IT will continue to completion in 2017, the potential enormity of the opportunity and the interim efficacy look by the independent Data Monitoring Committee projected to occur in 2016 demand that we be prepared for a potential early stop of the trial based upon overwhelming efficacy. Also, of course, we plan to do all that is possible to increase revenues from Vascepa's current indication in the U.S., while continuing to explore our x U.S. expansion opportunities. In the U.S., this entails expanded communication of the efficacy, safety and tolerability profile of Vascepa, leveraging recent managed care wins and building on the success that physicians regularly report regarding their treatment of patients with Vascepa. A growing number of research results further differentiate Vascepa from other triglyceride-lowering therapies and emphasize the potential broad clinical benefit of ethyl-EPA. We are thankful to our shareholders for their support. While I can't mention all of our investors by name, I offer particular thanks to Baker Bros. Advisors, which firm led the financing we announced in March; and Sofinnova Venture Partners, a long-time investor in Amarin, which, as described in our proxy statement, seeks to increase their investment in Amarin. As you might expect, these investors have performed extensive due diligence on Amarin, both with respect to the current indication for Vascepa and for our future prospects. We encourage other investors to conduct similar due diligence and believe that in doing so, they will become similarly excited about Amarin's current position and significant potential. With that, I would like to open up the line to some questions. Operator?

[Operator Instructions] Our first question today is coming from John Boris from SunTrust Robinson Humphrey.

First one for Aaron. On the market, have you conducted any market research or potential prescribed data? It would seem as though based on the recommendations on fenofibrate and the continued bleeder or drain on Lovaza users, what percent of patients are actually going on to no therapy? And if they are going onto some other therapy, what percent of patients are going on to Vascepa or some other therapy? Second question for Joe Kennedy, can you maybe just remind us what the sales rep case was, what the product was that was involved there? And just any kind of clarity you can give around how long it took that case to play out as maybe a proxy for what may happen here. And then third and final question for John, I know that you're certainly looking to ink additional deals in Western Europe and Eastern Europe, Lat Am and Middle East. Can you maybe just give some guidance on what the level of interest was? I think the interest for the China deal was pretty significant. Can you maybe just give some color or clarity around that?

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Now rejoining the speakers.

Folks, we're back. I apologize for the technical issues there. I hope to figure out what occurred and fix that for next time. But hopefully, you were able to hear the completion of our prepared comments. We'd now like to take questions. If questions were being asked, we didn't hear them previously. So operator, if you could queue that back up again for us, please. Thank you.

Absolutely. Yes, our first question is coming from John Boris from SunTrust Robinson Humphrey.

Okay. So first question, when you look at the decline in both fenofibrate and niacin, are these patients -- from any market researches you've pulled together, are they going on to no therapy or are they going on to some form of therapy, whether it's placebo or OTC fish oils? If you have any additional information there. And also, whether -- what was the increase in your formulary status and/or position within the quarter? Second question for Joe Kennedy; the sales rep case that you cited, can you remind us what that case was, what product it involved, the outcome and how long that case took as potentially a proxy for what may happen here with Vascepa? And then the third and final question for John; obviously, with the Eddingpharm deal that you inked in China, can you maybe just assess if the level of interest is similar to or greater than what you experienced in the China deal? I know you're looking at Western Europe, Eastern Europe, Lat Am at least in terms of inking deals. So any clarity you can give there would be appreciated.

Thanks for the multipart questions. Let me answer all the pieces of them, the one I'm going to throw to Joe Kennedy there first. So with regard to your questions on the overall space, the comments that we were attempting to make in the call were to reflect that in January and February, that prescriptions broadly, particularly prescriptions for drugs addressing chronic use, declined; it included diabetes drugs, it included others. But we -- particularly because it's most applicable to us wanted to reference statins and other sort of certain non-statin lipid-modifying drug, which includes the fenofibrates and the niacin. Based upon the data that we have seen, and this is through Symphony Health Solutions, those prescriptions or those therapies dropped in January and then in February, but like ours, increased again in March. Fortunately, ours didn't go down quite as much as the overall industry. And I'm not singling out individual drugs here. We don't have it drug by drug. I'm just looking at the categories as supplied to us by Symphony Health. We didn't decline as much as they did in January and February. And in March, they were up, but we were up further, again versus the entire category. We presented that not as sort of market commentary on physician use of other therapies or switches of other therapies, but rather on overall trends as it relates to topics like the severe winter weather and the fact that a lot of medical insurance plans have put our x's under the medical health benefit, which then subject them to the annual deductible. And there's others of procedural issues that start a year off. And last year, we had some sluggishness, as I think I referred to it in my comments in the first quarter, clearly had sluggishness here.…

Right. So John, as I understand your question, it is whether the U.S. v. Caronia case is an appropriate proxy to determine the timing of our case. And the Caronia case was a criminal case that played out where a sales rep was convicted for off-label promotion of a drug called Xyrem. That was a case that played out over a long period of time, and it's not an appropriate proxy for the timing of our case. That sales rep was convicted at a lower court level. It was appealed to the Second Circuit Court of Appeals, which is the jurisdiction in which we're filing our action. And the central holding of that case, which is what is an appropriate parameter to judge our case in, is that the U.S. Government cannot prosecute sales representatives and pharmaceutical companies for truthful and non-misleading speech, albeit off label about their products. So because that was a criminal case, it took a long period of time. What we're asking for is a judicial declaration, which we anticipate to take a significantly less period of time than a criminal action and the subsequent appeal. So when we look at the timing of this, in my prepared remarks, I said we would expect that to play out over the next 6 to 9 months. The actual timing is really dependent upon the judge and his schedule. We do plan to move forward to try to expedite the proceedings. This is not a set of proceedings where we believe science will be an issue. We believe that the information that we presented in the complaint is truthful and non-misleading. And we expect that we'll be able to just move towards a more straightforward assessment under the law for the judge to determine whether under the precedent within the Second Circuit, it is appropriate for us to go forward without the potential for government action based upon FDA's interpretation of the prudent drug cosmetic pack. So we'll have a better idea of timing as that case proceeds. We expect to move to expedite it in short order, and we should be able to update you as time goes on. But we would encourage investors to follow that suit most closely with the PACER system, which provides online access to all court filings.

And just as an add-on to that, but for emphasis, there is -- there are folks like Joe Kennedy who have focused on this First Amendment suit. And we think that this is in the best interest of patient care for reasons that have been described. But this is not an all-consuming activity. Our focus as a company remains on the objectives that I set out earlier. We have an improved indication. It's a terrific product. We're going to grow revenues off of that current indication. We have an outcome study. It's progressing. We're going to continue that. That is our focus and we don't want -- I mean, obviously being opportunistic along the way. But we don't want to -- because of the sizzle of a First Amendment suit or attention that, that may grab in the media, for example, to suggest that, that in any way dilutes the focus and the opportunity that we have in our business as it's currently presented.

[Operator Instructions] We have reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

Yes, I appreciate it. It's 9:00 a.m. here, and you guys are getting ready to get into action. I appreciate your interest in Amarin. I look forward to the follow-up. Your support is something we value and we intend to try to provide continued and important communications as we move forward. Thank you.

That does conclude today's teleconference. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.