Welcome to Amarin Corporation's conference call to discuss its Financial and Operating Results for the Second Quarter of 2015. This conference is being recorded today, August 6, 2015. I would now like to turn the conference over to Mike Farrell, Vice President of Finance for Amarin.

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 plans 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, August 6th, 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 if 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 statement section in today's press release and the risk factor section of our quarterly report on Form 10-Q for the three and six months ended June 30th, 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 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.

Thank you for joining us today. On today's call, we will discuss Amarin's recent commercial, operational, and financial performance; provide an update on company initiatives and legal matters; and then take questions from analysts and investors. Our priorities for 2015 remain unchanged: support/improve patient care with Vascepa, increase revenues, continue to execute on our cardiovascular outcome study REDUCE-IT, and manage our business in an opportunistic and cost-effective manner. We made significant progress in Q2 2015. Highlights include Q2 2015 prescription and revenue growth from Vascepa resulting in record levels for both, REDUCE-IT continuing to progress on schedule with enrollment now more than 95% complete. More important than enrollment progress, the cardiovascular event rate continues to track to our expectations for the protocol prespecified interim efficacy look by the independent Data Monitoring Committee, or DMC, in 2016. If not stopped early and the study is continued to completion, which is the base-case scenario, we expect study completion in 2017 with presentation and publication of results in 2018. We made meaningful progress in Q2 as it relates to various ongoing legal matters. Recent research findings further support the potential benefits of EPA, the active pharmaceutical ingredient in Vascepa. An in vitro study presented in June at the American Diabetes Association Scientific Sessions in Boston showed that exposure to EPA inhibited glucose-induced oxidation of small, dense LDL. Another in vitro study presented in June at the National Lipid Association Scientific Sessions in Chicago showed that the inhibitory effects of EPA on the formation and crystallization of cholesterol domain in model biological membranes subjected to high cholesterol levels in order to stimulate atherosclerotic-like conditions indicated a level of reduction with EPA that was not reproduced with other triglyceride-lowering agents tested. Such cholesterol domains are associated with the formation of atherosclerotic plaque. A further recent…

Thank you, John. As John mentioned, we're pleased that Vascepa prescriptions and revenues grew significantly in Q2 versus the same period last year and accelerated versus Q1 2015. In Q2, normalized prescriptions for Vascepa of 176,000 and 157,000 were reported based on data from Symphony Health Solutions and IMS Health, respectively. These normalized prescription numbers represent growth of 14% and 15%, respectively, over the first quarter of 2015. In Q2, normalized total prescriptions achieved all-time high levels and continued to outpace the growth of the total omega-3 category. Vascepa new prescriptions for the month of June were 23,463, growth of 8.3% over May. And normalized total prescriptions were 62,231, growth of 7.5% over May levels. For Q2, Vascepa prescription growth continued to be primarily generated from higher-decile physicians targeted by both Amarin and Kowa sales representatives. We believe that we have significant opportunity for continued Vascepa growth based on the currently approved indication supported by the strong efficacy, safety, and tolerability profile of Vascepa; the current size of our market opportunity; and the relatively limited penetration of Vascepa compared to earlier market entrants. In parallel with marketing Vascepa for its current indication, Amarin is preparing to expand its medical communications regarding Vascepa to healthcare professionals based on the letter we received on June 5th from the FDA in connection with the First Amendment litigation. And hopefully, our commercial team will be involved in implementing new programs after a favorable court judgment. Currently, most healthcare professionals are not aware of the results of the ANCHOR study and are not aware that we're conducting the REDUCE-IT cardiovascular outcome study. The extent to which we broaden our discussion of Vascepa results depends on the pending decision from the court. All such communication will be subject to disclaimers and other steps to ensure that…

Thank you, Aaron. 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 Q2 2015, we recognized $17.7 million in net product revenues, representing an increase of 40% as compared to net revenues of $12.6 million in Q2 2014. As previously described, the timing of shipments to the wholesalers varies from period to period. At the end of June, wholesalers held approximately six days fewer inventory than they held at the end of the December. We view this to be more of a matter of timing and not an ongoing trend that the number of days of supply on hand at our wholesalers tends to fluctuate based on the timing of their orders. On a year-to-date basis through June 30th, 2015, we recognized $33.3 million in product revenues as compared to $23.6 million in the same period in 2014, an increase of 41%. As John mentioned, our average net price per capsule sold in Q2 2015 approximated our average net price in Q1 2015. Such net pricing, as previously discussed, is lower in 2015 than in 2014 due primarily to the impact of additional rebates and, in particular, from expanded tier-two managed care coverage and increased utilization of such coverage. Our overall rebate levels remain consistent with industry practice. Cash collections from the sale of Vascepa in the six months ended June 30th, 2015, were approximately $47 million. And all of our customers remain current in their payments. In addition to Vascepa product revenue, we recognized licensing revenue of $400,000 in the six months ended June 30th, 2015, related to the Eddingpharm development and commercialization agreement that was executed in February 2015. The development process in China continues to progress, consistent with…

Thank you, Mike. Hopefully, through these comments, you get a sense for the progress we are making. A beacon for our efforts continues to be the enormous upside potential of success in the REDUCE-IT cardiovascular outcome study. We have not focused much on REDUCE-IT in our comments today. Hopefully, evidence to everyone is the very large potential presented for improved patient care and revenue growth if that trial is successful. In prior investor calls, we have described reasons we believe that this important study is positioned for success. And that perspective has not changed. With that, we conclude our prepared comments, and we move to open the line to some questions. Operator?

Thank you. [Operator Instructions] Our first question comes from Chris Hanacek, Bank of the West. Please proceed with your question.

Thank you. Just a question in terms of what monthly prescription volume you anticipate to exceed the breakeven point in terms of profitability for Amarin?

Chris, appreciate the question. This is John. So, as we were coming out of last year, so off of last year's sort of December prescription levels, we had commented that, at that point in time, we needed to roughly double our prescription growth in order for us to breakeven on a commercial basis. And I define commercial basis as being our cost excluding our R&D costs. And that guidance hasn't changed at this juncture.

Our next question comes from Akiva Felt with Oppenheimer. Please proceed with your question.

Sure. Thanks for taking the questions. John, could you walk us through the math and the calendar that hits the first ANDA or first potential ANDA approval at 2020? And would a challenger need to overcome all of the Orange Book-listed patents, including maybe any new ones that are listed in the extended period between now and the end of the NCE exclusivity?

I'd be happy to, but since I have Joe Kennedy, our General Counsel, sitting next to me and he's in the thick of that, let me turn things over to Joe to respond.

So, thanks for the question. So, for an ANDA to proceed with review at the FDA, the FDA would have to reaccept an ANDA right now. So, as we noted in our prepared remarks, the ANDAs, while originally submitted, have been -- their acceptance has been revoked. And so, right now, the FDA is not reviewing ANDAs. For that review to begin again, we believe that review would -- could only begin again after the exclusivity period for NCE would expire. And that would be July 2016. Right now, the court, in granting a summary judgment motion, remanded back to the FDA determination on NCE. So, what we're looking at right now based upon that strongly worded opinion is no acceptance of ANDAs until July 2016. Now, once they get accepted, typically, if you look at the review period for ANDAs, they can run up to three years of review. We believe that once an ANDA would be accepted by the FDA in mid-2016 or the second half of 2016, we'd then be entitled to a 30-month stay that would run out into the beginning of 2020. And so, that's the point in time that we see the ANDA litigation starting up again. And in terms -- to answer your other question, yes, there are many patents that we have listed in the Orange Book and that have been the subject of the patent litigation that's ongoing right now, which we're moving to dismiss. And not only would an ANDA applicant have to overcome each of those patents, but each of the individual claims in those patents. And when you add them all up, there are a few hundred claims in those patents. So, I hope that answers your question. If not, let us know.

No, that was great. Thank you, Joe. Maybe just a follow up, this is probably for John. Should we expect or anticipate that you guys are evaluating maybe other territory-like agreements similar to Eddingpharm but with a different company?

Sorry, Akiva. Can you just repeat that? There was a little static on this end.

Sure. Are you guys looking at partnership opportunities outside of China or similar collaborative agreements to Eddingpharm?

So, absolutely. As we had laid out in a prior discussion, in -- last year, our focus was on finding a commercial partner domestically, which we did with Kowa. We then focused our effort internationally and prioritized China, and we're very pleased with our relationship with Eddingpharm and that the efforts in China are progressing as expected. And we have great confidence in Eddingpharm to continue to progress matters there. And we have now moved to select other geographies in the world where we have discussions going on with various companies, different statuses in different geographies. There's enough interest there that suggests to me that something can happen. And I think what we and some of the people we're talking to would like something to happen deal terms on any of these things can often be protracted. So, we're not at this point in time giving guidance on the timing. A lot of factors to consider, but we are of a belief that Vascepa has global sales opportunities and global potential. Triglycerides, lipids are a problem almost everywhere in the world. And we'll look forward to being able to announce something when we conclude a deal but don't want to provide specific guidance on deals as these things are not entirely within our control.

All right. Great. Thank you.

And next question comes from Chris Hanacek with Bank of the West. Please proceed with your question.

Thank you. Under what scenarios would you anticipate initiating direct-to-consumer marketing?

Yes, so, this is John Thero. I appreciate the comment. At this point, our approval is for patients with very high triglycerides. It's an important indication, but it is a niche indication. It's an indication over which we think we can continue to grow. But, these are patients who, due to the nature of the label, tend to be getting special attention by their whether it be their primary care physician, cardiologist, or lipidologist. And we think that the best use of our resources are in educating the medical community on the importance of treating these patients, identifying these patients, and treating these patients in a way that doesn't offset the value of other therapies that such patients may be being treated with, in particular not offsetting the value of LDL therapy, where we believe our drug is uniquely positioned. So, our focus is there today. As we progress through here, we'll see what happens back on the First Amendment matter. We believe that's also an opportunity with healthcare professionals that the aim would be to use truthful and nonmisleading information to give healthcare professionals additional information to use in the treatment of their patients. Following an outcome study, whereby we had results which would definitively right now, what we have is significant data that is some of its genetics. Some of its clinical. Some of its epidemiological. There's a lot of information pointing to the health benefit provided by the active ingredient in product that helps benefits coming from the lipid reduction, coming from the anti-oxidation, coming from the anti-inflammation. It's broad benefit. But, after we have that benefit shown not only strongly suggested by the clinical, genetic, and epidemiological evidence, and by pointing to outcome study data from outside the US, once we have that based on a Western population, that's information we think will get fairly broad consumer attention just by the nature of the importance of the data but also would at that point in time be much more suitable for a direct-to-consumer campaign. Part of what we're doing here is growing revenues. But, part of what we're also doing is trying to make sure that we're being smart with where our cash is being used. And at this juncture, it's not trying to increase our burn rate. We've been making significant strides over the last two years to bring that burn rate down and try to get ourselves here to a position where we're cash flow positive. I think the outline I've just described to you is consistent with that. So, hope those comments are helpful.

Great. Thank you.

There are no further questions at this time. I'd like to turn the call back to John Thero for closing remarks.