Greetings, and welcome to the Amarin Corporation Third Quarter 2014 Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Farrell. Mr. Farrell, 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 our commercial and financial performance, including levels of Vascepa sales, revenues and other commercial metrics, expenditures, supply-related activities and the adequacy of our financial resources; our current expectations regarding regulatory filings, government agency decisions and potential label expansion; our current expectations regarding our cardiovascular outcome study, such as enrollment and the potential implications of our regulatory process on such study; our plan to protect the exclusivity and commercial potential of our products; and our current expectations regarding the effect of our copromotion agreement on our business. These statements are based on information available to us today, November 6, 2014. We may not actually achieve our goals, carryout 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 Factor section of our quarterly report on Form 10-Q for the 3 and 9 months ended September 30, 2014. 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 afternoon. Thank you for joining us today. On today's call, we'll discuss Amarin's recent commercial, operational and financial performance; provide a regulatory update; and then take questions from analysts and investors. During our comments, we will touch on our priorities of improved patient care, increasing revenues, successfully completing REDUCE-IT and doing all of the above in a cost-effective and opportunistic manner. We continue to get encouraging feedback from physicians on the positive effects of Vascepa with respect to the treatment of their patients. These comments reflect positive experiences of the drug's tolerability, safety and efficacy, including reported improvements in a broad spectrum of the patient's lipid and inflammatory parameters after taking Vascepa. Vascepa's revenues and prescription levels continued to grow in Q3. Net product revenues for the 3 months ended September 30, 2014 were $14.1 million, representing a 68% increase over net revenues of $8.4 million reported for the same period a year ago, and a 12% increase over net revenues of $12.6 million reported for the second quarter of this year. Vascepa prescription levels in Q3, as reported by Symphony Health and IMS, grew 20% to 22% over Q2. Timing of shipments to wholesalers, upon which revenues are recognized, and prescription levels can vary between periods. Such timing differences contributed to greater prescription growth than revenue growth in Q3 2014. As Aaron will discuss in more detail, we are advancing a number of initiatives to create further prescription and revenue growth. Overall, the strategy that we've implemented earlier this year, our relatively high-frequency detailing on the benefits of Vascepa to a select group of the highest potential target physicians, is working. We want our strategic efforts to work faster. The distraction caused by the launch of generic Lovaza should be largely behind us and we continue our work…

Thank you, John. John mentioned prescription growth in Q3. Let me quantify that growth before further discussing our progress. Normalized prescriptions for the quarter ended September 30, 2014, as estimated by Symphony Health Solutions and IMS Health, totaled approximately 132,000 and 113,000, respectively, representing growth of approximately 20% and 22%, respectively, over prescriptions during the previous quarter this year and representing growth of 78% as compared to the same period in 2013. Such prescription growth continues to be primarily generated from higher decile positions targeted by Amarin and Kowa sales representatives. For clarity, the term normalized prescriptions refers to prescriptions of 120 capsules of Vascepa representing a 1-month supply. We believe that Vascepa can grow considerably further based on the currently approved indication. Vascepa's scripts reached 10% share of the prescription omega-3 market in September, which is up from 8% in June despite the availability of multiple generic Lovaza products. Given the safety and efficacy profile of Vascepa, clearly, there is room to grow the omega-3 market share and of course, even greater room to grow based on Vascepa's current indication in the overall non-statin lipid lowering market. As has been true since we shifted the focus of our sales team earlier this year, overall prescription growth in Q3 was led by the group of target physicians who were in the highest deciles. In the most valuable group of the highest decile prescription omega-3 prescribing physicians, those in deciles 8 to 10, as targeted by Amarin's direct sales force, new prescription share rose to 18.2% in September from 16.6% at the end of June. Kowa has also significantly expanded our ability to reach additional physicians with Vascepa promotional messaging, many of whom have never been presented with a Vascepa detail. Q3 was the first full quarter that the Kowa sales…

Thank you, Aaron. Regarding the sNDA for the ANCHOR indication, the FDA assures us that they have resumed work on the sNDA review. When we have a definitive update, we will share it publicly. We note that during today's call, we are not going to comment further on the pending sNDA. Our primary focus currently is on advancing the REDUCE-IT study to a timely and successful conclusion, as doing so is both consistent with recent urging from FDA and, we believe, in the best interest of patient care and Amarin shareholders. Heart disease is the #1 cause of death in the U.S. and the world resulting in 1 in every 4 deaths. Statin therapy reduces CV risk by approximately 1/3. That's significant risk reduction, but there remains a significant unmet need for further risk reduction to improve patient care for the many millions of patients with cardiovascular disease. REDUCE-IT represents a compelling opportunity for improving patient care and for Amarin. As previously described, the epidemiological genetic and clinical data suggest that triglycerides and the lipoproteins that carry them are within the causal pathway of cardiovascular disease, and that treating elevated triglycerides can result in reduced cardiovascular risk. REDUCE-IT is the first prospective outcome study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. Before the REDUCE-IT study, no outcome study was designed to specifically address this triglyceride-lowering hypothesis. REDUCE-IT is also the first outcome study of a U.S. prescription level dose, 4 grams daily, of an omega-3 drug. Amarin's scientific rationale for the REDUCE-IT study is also supported by possible mechanisms of action of EPA, when used on top of statin therapy, that suggest cardioprotective effects independent of triglyceride-lowering. These mechanisms of action have been explored and described in the scientific literature,…

Thank you, Steve. My comments will address our recent financial results. You'll find a more detailed discussion of our results in our 10-Q and press release issued earlier today. In Q3 2014, we recognized $14.1 million in revenues, representing an increase of 68% as compared to revenues of $8.4 million in Q3 of 2013 and an increase of 12% as compared to $12.6 million in revenues in the second quarter of 2014. The timing of shipments to wholesalers, upon which revenues are recognized, and prescription levels, can vary between periods. As previously noted, such timing differences contributed to greater prescription growth than revenue growth in Q3 of 2014. On a year-to-date basis, we recognized $37.7 million in revenue through September 30, 2014 as compared to $16.2 million in the same period in 2013, representing a year-to-date increase of 133%. Our average price per capsule sold in Q3 2014 approximated the average price from the first half of 2014. Cash collections in the sale of Vascepa in the 9 months ended September 30, 2014 were approximately $45.2 million and all of our customers remain current in their payments. Gross margin during the quarter ended September 30, 2014 was 62% as compared to 56% in Q3 2013. Gross margin for the 9 months ended September 30, 2014 was 61% as compared to 52% for the same period in 2013. While our gross margin may fluctuate from quarter-to-quarter, overall, we expect our gross margin percentage to improve further beyond 2014 as we source lower-cost API. Our SG&A expenses in Q3 2014 were $19.3 million as compared to $28.3 million in Q3 2013, reflecting an intentional reduction in expenditures. SG&A expenses in the 9 months ended September 30, 2014 were $60.9 million as compared to $101.5 million for the same period in 2013. The…

Thank you, Mike. Amarin continues to make progress growing the Vascepa brand, advancing REDUCE-IT and preserving cash. We are confident that we can continue to make progress and we are actively pursuing ways to accelerate this progress. We have an experienced and dedicated employee base and in Vascepa, a product that works. We are optimistic about Amarin's future. With that, I would like to open the line to some questions. Operator?

[Operator Instructions] Our first question comes from John Boris with SunTrust Robinson Humphrey.

First question just relates to the Kowa copromote. Can you maybe give a little bit more granularity on number of physicians and number of details? And how confident you are that once they hit that 5 to 6 call activity on their respective physicians, that we'll begin to see, potentially, an acceleration after that 6-month period? And then second question just has to do with a competitor on the horizon, potentially Epanova. It sounds like they've had some supply issues in being able to enter the market. However, it appears that AstraZeneca, if and when they'll launch, will launch on their diabetes sales force. Can you just talk about the sizing of your sales force relative to AZN when they enter the market in that competitive front?

John, this is John Thero. Good to hear from you. I'm going to ask Aaron Berg, our head of Sales and Marketing to respond to your questions. Aaron?

Sure. So what we know is, in regarding Kowa, your first question, that physicians respond to the Vascepa message. In particular, when a number of calls to individual physicians exceed 5 or more, we've seen that data since launch with Vascepa and that continues. This is similar to other prescriptions that -- prescription products that are launched. And as you know, it takes time to generate that frequency level of calls to affect the prescribing habits. And it's one of the reasons why for copromotion partnerships, it often takes 6 months or even more for that relationship to begin showing a meaningful impact. So Kowa's targeting more than twice the number of physicians than we are alone, in the Amarin sales force. And as of the end of Q3, Kowa's sales team had called on each of their Vascepa targets an average of 2 times. So by the end of this year, the aim is for the Kowa sales team to have called on approximately 1/3 of their target physicians 5 times to educate them about Vascepa. So it takes time to build the frequency. We know the frequency with Vascepa -- with the Vascepa message does resonate with physicians and we know we affect behavior based on that. Now with that said, it is very early and we'll repeat that. But the early signs indicate that Kowa is having a very early positive effect. The data show that there's greater prescription -- new prescription growth in physicians called on by both Kowa and Amarin versus those called on by Amarin alone. So early signs are good. It's early. We'll continue to monitor. Our focus with both sales forces is on execution. And we expect both sales forces to continue to execute, to focus on quality of Vascepa calls, getting the frequency levels up as high as possible on a highest value physicians and we expect to see a return.

And regarding the second question, which is about Epanova. We know that, that product has been approved for a while. We're not sure of when it will be launched. We know that there's been, or at least we've heard, as you have, that it may be launched through that particular sales force. But they've got multiple products there competing for attention. As we've talked about in the past, there's many patients that have very high triglyceride that are not currently being treated. And any effort that increases awareness should be useful to all therapies relative to patient care. There's not been a head-to-head study between Vascepa and Epanova. But Epanova's, like Lovaza, contains both EPA and DHA. And it therefore, it raises LDL. And as Aaron was pointing out earlier, many of these patients are also on statin therapy. So a drug that will offset the effect of statin therapy, will be something that docs, as they become familiar with the LDL effect, will want to consider. And it also is a drug that has a very different safety and tolerability profile, which may cause some concern for patients and clinicians. Just as a note, in our MARINE study, we had 0 patients drop out of MARINE as a result of tolerability effects associated with Vascepa, whereas in their study, which was comparably, less than 3 months -- 12 weeks, depending upon dose, they had 5% to 7% of patients drop out due to side-effect profiles of the drug, which is something that we'll have to see how that plays out in the marketplace. There's other differences between the products. But we think anything [ph] that increases awareness out there will, overall, be good for the marketplace because this is an underserved market, and we think physician education in this…

Our next question comes from Jonathan Eckard with Citi.

This is Joel Beatty on for Jon. My first question is on REDUCE-IT. Could you provide more detail on when in 2015 enrollment is expected to complete? And then also, how do you anticipate the R&D costs will change after enrollment completes?

Joel, thanks for the questions. This is a trial, as we're getting into the late stages of enrollment, that we're trying to bring in for the appropriate landing, if you will. We did make a change to the enrollment criteria not too long ago, to emphasize the need for any patients being enrolled going forward to only have triglyceride levels that are above, I think 200 mgs per deciliter. That was intentional to give us the kind of balance of patients within the study that's consistent with the way that study was designed and the statistics for how we have the study design has. As we get closer to the end of the study, we're trying to make sure that we did the right patient mix. In all likelihood, events in the study, because it is an events-driven study, will probably come from the 7,000-plus patients who are already enrolled. And so whether we finish 1 month or different month probably won't have a huge impact on the timing of the trial being completed. The costs within REDUCE-IT bounce around for a variety of different reasons. During the enrollment phase, we've talked about the overall cost, and annual basis being between $30 million and $40 million on an annual basis. And that's been holding up. There are some savings that occur after enrollment is completed. Outreach in advertising efforts relative to patients, et cetera. But there are still significant costs going forward to ensure patient compliance and a robust study. We -- I think, we're commended by many physicians relative to our conduct of both the MARINE and ANCHOR study and how it was robustly conducted. And we're trying to ensure that here as the first study in this space that we're conducting it robustly as well. So while we do anticipate seeing some curtailment of costs in REDUCE-IT after enrollment is complete in 2015, it's not a halving of costs, but we haven't quantified it beyond that and the costs do tend to be variable enough from quarter-to-quarter that it's somewhat difficult to forecast or to articulate to you in terms of guidance.

Sure. That was helpful. And then one more question. I noticed in the 10-Q today, it says that the data monitoring committee has been more frequently examining the safety data from REDUCE-IT. What could be the reasons for that? And Is there anything that could be read into that?

It's -- this is Steve Ketchum speaking. It's just good standard practice for a trial of this nature for an independent data monitoring committee to meet quarterly to look at all available information. And so that was kind of the prespecified plan from the outset of this study. And in each of those instances the DMC has come back to Amarin and recommended continuation of the study as planned.

And then, given the profile of Vascepa coming out of both the MARINE and ANCHOR studies, we weren't anticipating safety or tolerability issues. But now, with a much broader accumulation of lives within the study and time on drug in the study, it's good to have that confirmed that. Not that we have seen the results but an independent group's looking at it and continuing to give us the thumbs-up moving forward. It's what we would've expected. But it's still confidence-building and we thought that we should be articulating to investors that which we know, which is we continue to get the thumbs-up on the safety side. The efficacy side, of course, is blind to that committee and to ourselves, other than whatever they might interpret based upon the safety.

Our next question comes from Max Kerker [ph] with Goldman Sachs.

I'm just filling in for Gary today. Could you maybe elaborate a little bit more on the cash burn and maybe a run rate and if you'll need possible additional financing? And then for my second question, I know that you talked about, like keeping the sales -- keeping the expenses relatively constant for sales efforts. But looking forward, do you see any possibility of maybe like, expanding it at all?

Thanks, Max, for the questions. I'll take the second one first only 'cause it parlays into answering the first one. So for the MARINE indication, we're currently approved. We think that we're adequately sized today. If we were to get approval for a broader indication or an ability to market a broader indication, that would be something we'd want to take another look at. But for the current indication, I think we're adequately sized, at least to the point in time where the sales force is fully paying for itself. Relative to the cash burn, as we've discussed a bit in the call, we have taken significant measures over the past year to increase productivity, reduce expenditures. I think our SG&A costs now are at a level that should be relatively consistent from period to period until, again, we sort of hit a threshold moment of covering those costs. Our R&D cost, the majority spending there is REDUCE-IT, which we've talked about that level of spending, really in response to an earlier question from Joel, which sort of leads as a variable to that revenue growth and related supply purchases for revenue growth. The -- we ended Q3 with $135 million in cash for this year as a whole. We anticipate burning not more than $80 million, of which we burned about $56 million of it, so far, $14 million and $15 million, respectively, in each of the last 2 quarters. Our focus is to continue to grow revenues, to advance REDUCE-IT and we're going to continue to look for ways to do this cost-effectively and opportunistically. And by opportunistically, I mean bringing on -- we did Kowa, that was opportunistic. We did a celebrity program, that's opportunistic. If there's things that we can do without adding a heavy cost burn that we think will add to the upside, we're going to continue to look for those things, that includes also, looking outside the United States. So we haven't quantified, beyond that, our cash burn levels, we may get into a bit more detail in conjunction with our 10-K in that regard. But right now, we're tracking to the guidance that we provided this year, which is keeping the cash burn under $80 million for the year and our focus is as I said, to continue to look for improvement based upon revenue growth. I hope those answers help.

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

Terrific. Thank you, operator and more importantly, thank you to everybody who's been on this call listening. We appreciate your interest and support, and we look forward to providing regular updates as we move forward. Good evening.

This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.