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Edited Transcript of AMRN earnings conference call or presentation 2-May-18 11:30am GMT

Q1 2018 Amarin Corporation PLC Earnings Call

Dublin May 9, 2018 (Thomson StreetEvents) -- Edited Transcript of Amarin Corporation PLC earnings conference call or presentation Wednesday, May 2, 2018 at 11:30:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Craig B. Granowitz

Amarin Corporation plc - Chief Medical Officer and SVP

* Elisabeth Schwartz

* John F. Thero

Amarin Corporation plc - CEO, President and Director

* Michael W. Kalb

Amarin Corporation plc - CFO and SVP

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Conference Call Participants

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* Joel Lawrence Beatty

Citigroup Inc, Research Division - VP and Analyst

* John Thomas Boris

SunTrust Robinson Humphrey, Inc., Research Division - MD

* Louise Alesandra Chen

Cantor Fitzgerald & Co., Research Division - Senior Research Analyst & MD

* Matthew J. Andrews

Jefferies LLC, Research Division - Equity Analyst

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Presentation

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Operator [1]

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Welcome to Amarin Corporation's conference call to discuss its financial and operating results for the first quarter of 2018. This conference call is being recorded today, May 2, 2018.

I would now like to turn the conference call over to Elisabeth Schwartz of Amarin.

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Elisabeth Schwartz, [2]

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Thank you all 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 prescriptions and wholesaler inventories; Vascepa product and licensing revenues; costs and other commercial metrics; gross margin, expenditures and the adequacy of our financial resources; our current expectations regarding our cardiovascular outcome study, such as study completion, regulatory review and likelihood of success; our plans and preparation for expanded promotion of Vascepa and related market positioning and potential and our goals regarding the timing and scope of international expansion.

These statements are based on information available to us today, May 2, 2018. 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 agreements 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 factors section of our quarterly report on Form 10-Q for the 3 months ended March 31, 2018. These documents have been filed with the SEC and are available through the Investor Relations section of our website at 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 its approved indication.

Please note that we are also providing slides to accompany this morning's call. These slides, which can be found on our website, amarincorp.com, in the Investor Relations section under the overview section, summarize some of the key updates discussed on today's call. Finally, an archive of this call will be posted on the Amarin website, again in the Investor Relation section.

I will now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

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John F. Thero, Amarin Corporation plc - CEO, President and Director [3]

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Good morning, everyone. This is a very busy and exciting time in Amarin. Last week, I participated in Amarin's annual meeting of our sales team. The members of this team are full of confidence and passion for the work they are doing to help health care professionals improve patient care with Vascepa. This is a very dedicated group of professional people, the majority of whom have been with us for multiple years. I go to such meetings, hoping to inspire them, only to find that they inspire me. Moreover, I regularly participate in meetings between Amarin's R&D team and key representatives from our CRO regarding the REDUCE-IT study. The results of this important study are near. We remain on track to achieve our estimated timeline of having results from this landmark study publicly announced before the end of Q3 of this year. For those of you are counting, this means that we anticipate knowing the results of this important study less than 5 months from today.

Mike Kalb, our CFO, will focus on Q1 financial results in his comments. On this call, I will primarily discuss the status of the REDUCE-IT study. I will also comment on broader market dynamics, which I view as favorable, but which at first glance may appear otherwise to some of you.

Regarding REDUCE-IT, as we recently announced, based upon pool, blinded data available to us in the industry standard projection methods, we estimate that the study has reached the onset of the targeted 1,612 primary major adverse cardiovascular events, or MACE, specified in the study design. Some people ask why Amarin didn't wait for final adjudication of all events in the study before having patients commence their final site visits. One of the reasons is that, according to the study protocol, some of the cardiovascular events cannot be finally adjudicated until data is available from diagnostic testing conducted as part of the patients' final site visits. Another reason is that it often takes months to appropriately identify and complete final adjudication of events. If we waited for the 1,612 primary events to be positively adjudicated, there would be more events which would occur during the intervening period that would need to be included. This would add unnecessary cost and slow down the results of the study as we pursue adjudication of these additional events.

The method we've employed to determine when to commence the final patient visits is industry standard. We are anxious to announce the results of this important study. We believe that we can reasonably estimate the number of primary major adverse cardiovascular events, based upon industry standard methods of projecting future events, based upon event rates experienced during the study's multi-year history, and collective knowledge gained from several other previously executed successful cardiovascular studies.

Also, as a reminder, the REDUCE-IT study does not need to hit the exact number of events around which the study's power was designed, which is 1,612 primary events. The powering of the study results will not be significantly impacted by a final primary event number, which is slightly more or slightly less than the 1,612 planned events. If we miss on the 1,612 primary events count target, we believe that we are unlikely to miss by an amount which would have a meaningful impact on study results. Based upon events that have already been adjudicated, in on estimated adjudication rates for events that have already been identified, we already have greater than 97% of the targeted 1,612 primary events. Based on the trials multi-year history, we anticipate that additional primary events have occurred. These additional primary events are pending formal adjudication by clinical sites, consistent with a lag time in event identification experienced by clinical sites throughout this conduct of study.

We continue to anticipate that the final results of the study will benefit from the robust study design envisioned at the onset of the study in our refinement of the study design and protocol through our Special Protocol Assessment agreement with the FDA, which we amended as announced in August 2016.

The clinical path for completion of the REDUCE-IT study and announcement of results involves multiple operational steps. Many of these operational steps occur simultaneously. For example, it is anticipated that final adjudication of all primary events will be completed as operational steps needed for study completion are conducted. Other remaining key operational steps include: One, all active patients in the study need to complete their final site visit. After patients complete their final site visits, they are finished with respect to the study. Two, all inactive patients of the study must either be confirmed as dead or alive. It's common in large multi-year clinical studies for some patients to move residence, or for other reasons, drop out of a study.

The powering of REDUCE-IT, like other studies, is based upon a number of patients who experienced major adverse cardiovascular events during the term of the study. However, if an inactive patient died or otherwise incurred a major cardiovascular event, we still seek to know their vital status for purposes of data completeness. In particular, we want to be sure to capture all deaths which have occurred even if a patient moved or was otherwise inactive in the study.

Third, all data from these steps -- in all our other data from our now more than 35,000 patient years of study in the trial, need to be rolled up into a database, scrubbed and cleaned in the context of clinical trials, mean that the data will be reviewed for completeness and consistency. Missing data, if any, will be sought and added to the database.

We at Amarin remain blinded to the above steps until they are completed and the database locked. We do manage study progress in a pooled, blinded manner. We know that considerable progress has been made against each of these steps. For example, over 97% of active patients have completed their final site visits or are scheduled to do so very soon. As is typical for clinical trials, tremendous effort is ongoing to ensure that we gather all necessary data from all patients in the study. Our progress regarding these operational steps needed to complete the study is within our expectations for study completion. We recognize the getting the final few percent of patient final data is often the most difficult in clinical trials. We, our CRO, and clinical sites are working together to get that data from these outliers as soon as possible.

We are very thankful to the patients who have participated in the study, to the clinical sites involved in the study, to our CRO and its staff for their considerable efforts and experience and to our advisers and, of course, to our own employees who have worked tirelessly for many years on this important study. We believe that these studies' results will be worth the effort. Of course, we are all very excited to see and announce the study results.

After these 3 operational steps are complete, meaning after the database is complete, clean and final, it will be locked. After the database is locked, a special electronic key will be added, which sorts patients between those who have been on statin plus placebo, from those who have been on stain plus Vascepa. Throughout the conduct of the study, the capsules that contain placebo and the capsules that contain Vascepa have been identical in appearance. Distribution of these capsules by patients has been randomly sorted by a computer program. No person at Amarin, our CRO, or the clinical site knows which patients receive placebo versus Vascepa and the patients themselves do not know.

After the special electronic key is removed from its secure location and added to sort the final locked database, a small number of representatives from Amarin and its advisers will conduct the efficacy and safety analysis of the results, including analysis of the trial's primary endpoint of primary MACE events in the study. As soon as this initial group of representative conclude that the top line results of this study are understood, they will let me know. Promptly, thereafter, we intend to inform the world through a press release.

At this time, we cannot provide a more refined estimate of the timing of the announcement of top line results from REDUCE-IT. It is not possible to precisely determine how much time it will take to get the database locked. That time frame will primarily be a function of having patients complete their final site visits, determining how much data is missing and then gathering and inputting the missing data. We want to get the data as quickly as possible, we also want to ensure that the final result is clean and robust.

To repeat, Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked. There are many reasons why we believe that this study is positioned for success. None of those reasons are derived from Amarin having any glimpse at the results of the study, nor have our advisers or clinical sites seen the unblinded data.

Unfortunately for patient care, cardiovascular disease is on the rise. Costs related to managing cardiovascular disease are soaring and the number of deaths from cardiovascular disease is again increasing. Clearly, a new solution is needed. Assuming REDUCE-IT is successful, given its profile as a pragmatic therapy, meaning it's effective, safe, well tolerated, easy to administer and affordable, we believe that Vascepa holds the potential to cost effectively help tens of millions of patients.

As a reminder, the demonstrated clinical effects of Vascepa are broad. Vascepa improves the spectrum of lipid and atherogenic biomarkers as well as factors associated with atherosclerosis, such as inflammation. One of these biomarkers is triglyceride. We are using triglycerides as a standard recognizable means to identify patients with elevated cardiovascular risk after statin therapy and then seeking to treat the risk with the broad effects of Vascepa. Some physicians may use other markers of risk, such as Apo B or hsCRP to help them decide to treat patients with pragmatic Vascepa. However, triglyceride levels are a convenient identifier of risk, as triglycerides is measured on all lipid lab tests. In part, we pre-specified triglycerides as a marker risk, because consistent with typical assessments of cardiovascular risk in medical practice, when doctors call for a report on LDL cholesterol levels, that report typically also includes triglyceride levels. Despite most lipid panels showing whether a patient's triglyceride level is elevated or normal, historically, treatment for triglycerides has been limited due to multiple factors, including the earlier generation triglyceride-lowering agents have various side-effects, including raising LDL or bad cholesterol, or problems with tolerability, particularly when combined with statin therapy. Moreover, these earlier generation therapies never conducted an outcome study of patients with that pre-specified elevated triglycerides as an entry criteria. Amarin, through our product Vascepa, which is differentiated from this earlier generation therapies in multiple ways, including that it doesn't raise LDL-cholesterol and is well tolerated, both when used alone or with a statin, will soon provide the medical community the outcomes data it craves. This outcomes data will be Vascepa-specific, reflecting the broad effect of Vascepa on major adverse cardiovascular events, not just the effects of lowering triglyceride levels.

Over the past decade, there have been various reports regarding the prevalence of adults with elevated triglyceride levels. These reports generally show that greater than 1 in 4 adults in the United States have elevated triglyceride levels. High triglyceride levels are not limited to the United States, which is part of the reason why REDUCE-IT is being conducted in 11 countries. And last week's National Lipid Association's annual scientific sessions, Dr. Nathan Wong, using NHANES data, presented an analysis that showed that while more than 1/4 of American adults have elevated triglyceride levels, the percentage of adults on statins with elevated triglycerides is even higher. There are approximately 38 million patients in the United States on statin therapy, and many more who should be on statin therapy. Helping these millions of patients lower their cardiovascular risk, as identified primarily by their triglyceride levels, will be our top priority, assuming REDUCE-IT succeeds.

During the 6-plus year conduct of the REDUCE-IT cardiovascular outcome study, data has grown, suggesting that REDUCE-IT should succeed. I'm not going to go through all of that data on this call, as it's massive. References to key publications are included on our corporate website at www.amarincorp.com, under the Publications heading. This supporting data includes vast epidemiological, clinical and genetics data. Such data is further buttressed by recent real-world evidence studies. We recognize that all of this data, while suggestive is not conclusive, which is the reason we are prospectively conducting REDUCE-IT as a double-blinded cardiovascular outcome study. Nonetheless, this currently available data continues to give us considerable confidence going into the REDUCE-IT results that REDUCE-IT is positioned to be successful and because of the reasonable cost of Vascepa and the safety profile of Vascepa that this provides an opportunity to usher in a new era in the preventative treatment of cardiovascular risk after statin therapy in appropriate patients.

Please note the key premises regarding the REDUCE-IT study and its differentiation versus prior studies are that, first, elevated triglyceride levels are a potentially effective identifier of modifiable cardiovascular risk. Enrollment and treatment of patients with higher risk is more likely to result in observable relative risk reduction. Second, the mechanisms of action of eicosapentaenoic acid, or EPA, the active ingredient in pure Vascepa, are broad, going beyond triglyceride lowering alone, and different than other add-ons to statins that have been tested in the past. And third, assuming REDUCE-IT success, the tolerability profile of Vascepa and its affordable cost make Vascepa a pragmatic therapy for clinical study and rapid uptake in clinical use.

Underlying these premises, in contrast to other omega-3 studies, key points of differentiation are that, one, the drug used matters. Vascepa is unique, it provides a broad spectrum of benefit, including lowering triglycerides without raising LDL cholesterol, which is different from other omega-3 products available in the United States. Two, the dose level administered matters. It is important to get sufficient EPA into the bloodstream to broadly enter endothelial cells and to otherwise have broad effect.

In the ANCHOR study, 4 grams of Vascepa per day in a Western population was shown to achieve EPA levels in plasma at a similar level as was achieved with the EPA dosing in the successful JELIS outcome study in Japan. EPA as a drug is not some form of enzyme inhibitor, where a low dose might be sufficient. Rather, we seek to get enough EPA into the bloodstream that it interfaces with particles in the blood in the surface of arteries throughout the body. Dose levels are important. Higher doses and higher serum levels of EPA in the ANCHOR study was shown to have more biological activity against a range of lipid and other biomarkers. In the ANCHOR study, the effects of 2 grams per day of Vascepa is potentially helpful. But we observed that the effects on lipid and other biomarkers from dosing at 4 grams per day of Vascepa is considerably stronger.

Third, the patient population studied matters. REDUCE-IT is intentionally studying populations of patients at high risk, where the impact of therapy should be recognizable over a period of years, not decades. Had we designed REDUCE-IT to study all primary prevention patients without other factors suggesting high cardiovascular risk, one would expect that many more patients would have been needed to be enrolled, or a much longer study time would be needed to accumulate 1,612 patients with primary major adverse cardiovascular events.

We believe that the importance of these 3 factors; right drug, right dose and right population, is evident in the meta-analysis on Fish Oil Studies published in JAMA in Q1 of this year. It is consistent with our hypotheses of these studies, the majority of which used omega-3 mixtures that included DHA, with the mixtures being at only 1 gram per day, did not show a statistically significant reduction in cardiovascular events.

In addition to studying a less pure drug formulation than Vascepa and studying such mixtures at relatively low daily dose levels, most of these studies were conducted in relatively low-risk patient populations. It is not surprising to us that such studies failed. The published meta-analysis shows one exception, the JELIS study. Notably, JELIS, which has a positive result, is the only pure EPA study in the analysis.

I want to make clear that the results of the JAMA article are consistent with our hypotheses that low dose omega-3 mixtures with DHA have limited or no effect. Low dose dietary supplements are not intended to treat serious medical conditions. Furthermore, assuming REDUCE-IT is successful, we believe such meta-analysis will be valuable in helping to make clear that Vascepa is unique and performs differently than dietary supplements for omega-3 drugs that contain DHA and increase LDL cholesterol.

There are results upcoming from 2 outcome studies, both of which study 1 gram per day of Lovaza, I'm referring to the VITAL and ASCEND studies. These studies are evaluating outcomes effect of 1 gram per day of Lovaza, or generic Lovaza, plus either Vitamin D or aspirin respectively, on cancer and cardiovascular disease in primary prevention patient populations. It is most likely that these studies will not succeed, because they are using an omega-3 mixture, rather than pure EPA, because the dose levels that they're using are relatively low, and because the patient populations they're studying are relatively low risk. We appreciate that these studies are being conducted. If they do not achieve their endpoints, such failure will help solidify multiple prior conclusions that low doses of omega-3 mixtures don't work effectively to lower cardiovascular disease risk and further distance the clinical effects of high-dose pure EPA Vascepa from low dose omega-3 mixtures. If the studies succeed, while we believe that this would be somewhat of a surprise, it could lead us to believe that the impact of Vascepa in REDUCE-IT maybe even more pronounced than we currently anticipate. In either scenario, we look forward to the results. Based upon valuable information, we anticipate the results from the first of these studies in and around June of this year. Also, note that these studies rely on patients to self-report information, which is considered to be a lower standard of study rigor. In addition, unlike REDUCE-IT, these studies are not being conducted under Special Protocol Assessment agreement with the FDA.

In the lipid space, over the past year, we have seen a series of clinical trial reports. There is CANTOS, which demonstrated that lowering inflammation can lower cardiovascular risk. This data is encouraging for REDUCE-IT, because Vascepa also lowers certain markers of inflammation. There's also been 2 PCSK9 studies (inaudible), and honestly, both of which demonstrated that lower is better regarding LDL cholesterol. These studies also suggest that significant residual cardiovascular risk remain after well-controlled LDL cholesterol, even when the LDL cholesterol is nearly fully eliminated. We do not believe that it's possible to draw any conclusions regarding the likely results of the REDUCE-IT study from these PCSK9 studies for 3 primary reasons. First, the mechanism of action of PCSK9 and Vascepa are very different, and it is not possible, based upon my understanding, to draw scientific conclusions based upon the effect of one drug as compared to another drug with dissimilar mechanisms of action. Second, while lowering LDL cholesterol is valuable, statin-treated patients and high-dose statins seem to drive limited remaining benefit, because LDL cholesterol has already been driven down significantly by statin therapy. In contrast, we know from multiple studies that approximately 60% to 75% of the residual cardiovascular risk remained even when LDL cholesterol is well controlled. Accordingly, there is considerably more opportunity for an effect from therapy which addresses risk factors beyond LDL cholesterol.

And third, look at the (inaudible) of the epidemiological, clinical and genetics data associated with triglyceride lowering, an improvement to factors leading to atherosclerosis [as it is] impacted by Vascepa. These effects are broad, and we believe support our hypotheses that significant cardiovascular risk reduction can be achieved via administration of 4 grams per day of pure EPA Vascepa.

In any case, we will know the results soon. While I see an important place for PCSK9s, I see their relative risk reduction and the positive reception that they're getting from clinicians, despite their high cost, to be positives leading into the REDUCE-IT results. I also see the potential for Vascepa to help millions of patients. Vascepa is not seeking to compete with cholesterol-lowering therapies, rather Vascepa is looking to address the significant risk which remains in patients beyond the benefit of cholesterol therapy.

Deaths from cardiovascular disease are increasing, cost of cardiovascular care is increasing, we believe Vascepa can help. A successful result with REDUCE-IT could greatly impact current treatment practices to reduce cardiovascular risk, the leading cause of death in the United States. Our commercial team is continuing to prepare for expansion following REDUCE-IT results. Some of you may have seen the pilot TV advertisement focused on our current indication of triglyceride levels of greater than or equal to 500 mgs per deciliter that we've started running in April on a limited basis on a national and regional level. We received encouraging feedback from viewers. As a reminder, the purpose of this pilot program is to increase Vascepa awareness and to better understand what messaging works in advance of a potentially broader promotional campaign after REDUCE-IT results. In order to broadly affect patient behavior, we recognize that we would need to run the commercial much more frequently, as surveys for most advertisements show that it typically requires 6 or more of viewings for people to take action based upon a commercial. However, creating general awareness can be achieved with a lower number of viewings and we are hoping that such aided awareness regarding Vascepa prior to REDUCE-IT results will help us after REDUCE-IT results have been communicated.

Regarding increased Vascepa awareness, we are also continuing to be active at medical meetings. Assuming REDUCE-IT is successful, we anticipate significantly increasing our sales force before the end of this year.

I'll now turn the call over to Mike Kalb, our Chief Financial Officer to update us on our financial results. Mike?

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Michael W. Kalb, Amarin Corporation plc - CFO and SVP [4]

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Thanks, John. The first quarter of 2018 showed continued growth of our commercial footprint, despite challenging headwinds from seasonal factors. Amarin's net product revenue for Q1 2018 was $43.8 million, an increase of 27% over the same quarter of 2017. The core driver of this year-over-year increase in our Q1 2018 net product revenue was continued growth in new and recurrent Vascepa prescriptions. Symphony and IQVIA data for Q1 showed estimated normalized total Vascepa prescriptions of approximately 381,000 and 392,000, representing respective increases of 25% and 27% over the same period of the prior year.

Net product revenue and related prescription levels in the first quarter of each of the past several years appeared to have been held back by certain seasonal factors. We have mentioned these factors previously, including public reminders at the start of Q1 of this year. The most significant seasonal headwind comes from beginning of the year medical deductibles under patients' insurance plans. There has been a growing trend in annual insurance coverage for patients to begin the year with patient deductible amounts of $1,000, $2,000 or sometimes much more than $2,000. Such deductible amounts cause many patients under such insurance plans to experience significant financial challenges. At the start of the year, rather than paying the co-payment amounts they were accustomed to paying at the end of the prior year, when they go to fill the same prescriptions in the new year, they're faced with paying significantly more, due to the high beginning of the year deductible under their insurance clauses. Most Vascepa patients are on multiple therapies. Accordingly, for example, a patient might go to fill 5 prescriptions and be accustomed to paying the co-payment amount of $20 for each prescription, or $100 in the aggregate. Instead, due to their high beginning of the year insurance deductibles, patient goes to fill the same 5 prescriptions in the new year and is told that there are several hundreds or even thousands of dollars for the drugs, because they have not satisfied the new year deductible. While some patients elect to pay for all the 5 drugs and get through their deductible quickly, the cost is too much for many patients. As a result, such patients typically fill the prescriptions for their pain medication and other drugs without which they will have an acute response and often forgo filling drugs for asymptomatic chronic conditions.

Every year, this is an issue for Vascepa and various other therapies. In 2018, this phenomenon appears to be more widespread than we expected. As a result, while our net product revenue in the first quarter grew 27%, this growth was slower than we expected at the start of the quarter. Insurance coverage for Vascepa remains broad. The high beginning of the year insurance deductibles for patients are not Vascepa-specific. Our sales team is upbeat and confident that physicians will continue to write Vascepa prescriptions for new patients, while in parallel efforts are made to get patients who have ceased filling Vascepa prescriptions in the first quarter due to insurance deductibles, to resume filling their Vascepa prescriptions. New prescriptions of Vascepa have recently hit record levels. Some patients are still working through their insurance deductible amount for the year. However, we are optimistic, based on prior year results that many of them will return to Vascepa. We continue to believe that Vascepa net product revenue for 2018 will reach $230 million, with such guidance to be adjusted when we learn REDUCE-IT results. Compounding the seasonal effect in Q1 caused by insurance deductibles, during the first quarter of 2018, customer inventory levels decreased from year-end 2017 levels by approximately $3 million, which is comparable to the decrease experienced in Q1 of 2017. We believe that changes in channel inventory at these independent wholesalers and retail pharmacies are common and are impacted by numerous factors, including recent order trends. We also believe based on information available to us that channel inventory levels at the end of the first quarters of 2018 and 2017 are within ordinary ranges.

In addition to net product revenue, we recognized licensing revenue of $0.1 million and $0.3 million in the 3 months ended March 31, 2018, and 2017, respectively, related to agreements for the commercialization of Vascepa outside the United States. Internationally, the clinical trial of Vascepa in China as sponsored by our partner Eddingpharm, continues to progress. And in March 2018, we received the first international approval of Vascepa. This first approval is from Lebanon. Our partner in the Middle East, Biologix, is actively working towards approval of Vascepa in additional countries. We anticipate modest sales of Vascepa in Lebanon beginning later this year.

Gross margin for product revenues was 76% in the first quarter of 2018. Selling, general and administrative, or SG&A expenses for Q1, 2018 and 2017 were $43.4 million and $34.2 million respectively. The increase in SG&A expenses primarily reflects an increase in sales and marketing expenses, which include expenditures for anticipated expansion following successful REDUCE-IT results and an increased co-promotion fee. The increased co-promotion fees reflect both higher Q1, 2018 gross margin compared to Q1, 2017, upon which the base co-promotion fee is calculated and an incremental accrual of approximately 55% on top of the base co-promotion fee to be paid in future years as a tail payment under the terms of our contract with our co-promotion partner Kowa.

Research and development expenses for Q1, 2018 and 2017 were $11.8 million and $10.8 million respectively. This increase was primarily driven by timing of REDUCE-IT expenses and related costs. Amarin reported cash and cash equivalents of $129 million as of March 31, 2018, which includes approximately $70 million of net proceeds from the equity offering completed in Q1, 2018. As of March 31, 2018, the company also had $39.2 million in net accounts receivable, $57.6 million in gross accounts receivable before allowances and reserves and $35.1 million in inventory. Our net cash flow continues to be variable from quarter-to-quarter. Excluding proceeds from the equity financing completed in the first quarter and excluding other financing-related amounts, interest and royalty, and without the company's high level of research and development payments, most of which relates to advancing the REDUCE-IT study to completion this year, that cash outflow in the quarter ended March 31, 2018, was approximately breakeven.

Research and development spending should significantly decline after completion of the REDUCE-IT study and initial publication of its results. Cash outflows relating to research and development in Q1, 2018, totaled approximately $11.3 million, and cash paid for interest and royalties in aggregate was approximately $5.9 million.

As of March 31, 2018, Amarin had approximately 293.6 million American Depositary Shares, or ADSs, and ordinary shares outstanding, 32.8 million share equivalents Series A Convertible Preferred Shares outstanding and approximately 25.7 million equivalent shares underlying stock options at a weighted-average exercise price of $3.35 as well as 12.4 million equivalent shares underlying restricted or deferred stock units.

I'll now turn the call back over to John for closing remarks.

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John F. Thero, Amarin Corporation plc - CEO, President and Director [5]

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Thank you, Mike. Before closing, I want to express my sincere appreciation for everybody listening today, our employees, our stockholders, our partners, and our REDUCE-IT patients in clinical sites. We look forward to updating you on our progress.

With that, we conclude our prepared comments and we'd like to open the line for some questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Louise Chen with Cantor Fitzgerald.

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Louise Alesandra Chen, Cantor Fitzgerald & Co., Research Division - Senior Research Analyst & MD [2]

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I had a few here. The first question, just regarding the Vascepa sales on a quarterly basis. I know you addressed it at length in your prepared comments. But how should we think about the quarterly progression? Is there a specific quarter of catch-up, given the results in the first quarter? And second question I had is on what actions are you taking now to drive the commercial uptake of a Vascepa prior to REDUCE-IT? Is there anything going on there? And then last question that we get a lot is how quickly you think the REDUCE-IT results, supposing they are positive, will drive the uptake of Vascepa?

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John F. Thero, Amarin Corporation plc - CEO, President and Director [3]

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Louise, thanks for the 3 questions. Regarding revenues and how to look at them from a quarterly basis, I think we've always encouraged, probably the best way to look at our revenues is year-over-year due to the seasonal factors. Embedded in your question, maybe the -- Q1 was a decent quarter, up a little under 30%. Mike made the comments about record levels of NRx and it's always good to see NRx growing, and in this case, exceeding TRx, which tends to be a good sign for the future. We've got a record number of physicians prescribing Vascepa, also positive. That being said, when patients don't fill scripts, as they didn't in many cases in the first quarter, our aim is to bring those patients back. It's somewhat difficult to predict when they come back. Do they come back on their own or they wait and see -- come back with their doctors. So we come into Q2 with a little bit more of a deficit to start off with in terms of run rate than what we expected. We reiterated on this call, we think we'll get to $230 million for the full year. But I think as you sort of look at it, there were some headwinds here at the beginning of the year. Our team is very motivated, and they say [NRx is a rough, prescribers are rough] there are a lot of positive signs, but there's still a lot of work to do, which I think sort of leads into your second question of what are we doing relative to commercial uptake now. I'll take one of those things off the board. I think the advertisement we're doing on television could have some impact down the line, we just started that in Q2, but that really isn't being run with enough frequency to significantly drive short-term demand. We do think [that's to simply] drive awareness that will be beneficial to us later in the year, particularly after the REDUCE-IT result. So we're not counting on that limited advertisement to have dramatic short-term impact. Our sales force continues to be somewhat of a specialty sales model, in that it's only addressing a limited number of physicians in a limited number of states, and a limited number of geographies in those states. We have continued to see that -- within the physicians that we target that there is additional room for growth. We've grown on that basis in past years and we've essentially kept that footprint that's worked for us in the past. There is always refinement of messaging that can be done, and we're sort of building on what we've done in the past, while in parallel, preparing for the REDUCE-IT results across a range of scenarios. And those range of scenarios include different levels of relative risk reduction in the study as well as how much information can be communicated in the initial press release as well as publication, timing thereof, and what sort of obligation do we have to ensure that our promotion is updated to be truthful and non-misleading based upon the scientific information that is presented by the REDUCE-IT study. In terms of -- around the timing of REDUCE-IT, what can be said really will depend upon those results. [As I said], we've got an obligation to update what we are promoting to ensure that it is factual and non-misleading and as a first-ever study in this important population, based upon sort of [back-draw and] inquiries by media, based upon back-draw and inquiries by leading medical professional organizations and others, we think these results will get a lot of attention, but we need to see those results before we can really fully define what our promotion will -- the timing of that promotion and the content of that promotion after the REDUCE-IT results. Hope those comments were helpful.

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Operator [4]

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(Operator Instructions) Our next question comes from the line of Joel Beatty with Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP and Analyst [5]

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What do you expect you need to show as the minimum results for REDUCE-IT in order to maintain the current level of sales?

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John F. Thero, Amarin Corporation plc - CEO, President and Director [6]

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I'll try to make sure I fully understand the question, because currently we're [settling] off of biomarkers. We've got positive or statistically significant results on an outcome study that's a world of difference versus what we're filling on today. So our trial is designed around 15% relative risk reduction, we're seeing tremendous excitement on PCSK9s, at least by the cardiologist community in particular and they are expensive. And we've got a profile that's affordable, well-tolerated placebo-like safety profile. So our marketing surveys have suggested that or physicians that anything from sort of 7%, 8% up would be viewed as being a well-received result. We're aiming for higher than that. I think the data suggests it will be higher than that. What we saw when the initial results of the IMPROVE-IT study came out for ezetimibe that there was a lot of excitement; different population, different drug. We are not competing with those drugs, but there was a lot of excitement, and around the 7% and we've got a -- I believe a safer, more pragmatic, more affordable -- or affordable health profile that fits well there. So outcomes data is what docs want. 96% of patients with elevated triglycerides receive no therapy at all, because there is no outcomes data. If there is a positive -- statistically significant results from the REDUCE-IT study, I think that's a significant game changer. I would say we love it to be 15% or greater, greater will be terrific. But it's somewhat of a non-comparison, really, the idea of going off of biomarkers to going off of outcomes. If the outcomes are positive, we're in a new game.

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Operator [7]

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Our next question comes from the line of John Boris with SunTrust Robinson Humphrey.

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John Thomas Boris, SunTrust Robinson Humphrey, Inc., Research Division - MD [8]

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First question just has to do with the primary endpoint, the secondary endpoint analysis, more specifically on the secondary analysis. Obviously, you have an opportunity as agreed to with the FDA in the paper that you published on the clinical trial design that there's a vast number of secondary endpoints. Diabetics, obviously a very big group, but what are the important secondary endpoints that are important for market segmentation that you believe or important that you need to hit on? And then -- on the -- second question on the commercial pilot program. Do you have any metrics in place to measure the return that you're getting on the $15 million to $20 million that you're investing in that commercial pilot program? In other words, if you're doing the TV ad, are you measuring the number of hits that are coming into the Vascepa website as an indication of patients looking for therapy and intend to see a physician?

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John F. Thero, Amarin Corporation plc - CEO, President and Director [9]

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Let me start with the second one first. Relative to the pilot promotion program, we're doing that with one of the leading advertising firms in the world and they have all those kinds of metrics set up. So we're clearly measuring hits to our website and those kind of things, which have been pretty robust here to start with. What we're predominantly doing is we took a measurement of unaided awareness at the beginning of the study, and we are going to be running commercials for a bit and we'll pause for a little bit, take another unaided awareness measure and then we will start up for a little bit and we'll take another unaided awareness measure. And the unaided awareness measures looking both at physicians and consumers. And to me, right now, I think the physician piece is as important or more important than the consumer piece, because we know that the majority of physicians who potentially write Vascepa started off with very low awareness of the product, largely because we just don't call on them. So going into REDUCE-IT results, when those results come out, would like those physicians to have some identity as to what Vascepa is. So we're definitely measuring it, it's still early, we've only been running the commercial for a month and we've been running it with considerably lower frequency than you would run it if you are really trying to use it to drive short-term demand. But for the reasons I described earlier that's not where we're starting and that would be a considerably more expensive program, but I do think that this will position us and we are measuring along the way as to how are physicians just were preparing for REDUCE-IT results. So I hope those questions are useful. I've got both Craig Granowitz who is our Chief Medical Officer and Steve Ketchum, who is running the REDUCE-IT study here with me. Craig, maybe you could jump in on the secondary endpoints, which ones you see from a physician perspective to be most intriguing.

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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer and SVP [10]

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John, thank you for your question, I think it's a very important one, and is one that is always looked at very carefully in these large cardiovascular outcome studies, where there are very -- a large number of important endpoints and important endpoints for clinical practice, beyond those that are specified by the health authorities. As you know, the primary endpoint is a 5 point MACE of cardiac death, non-fatal MI, non-fatal stroke, coronary revascularization and unstable angina requiring hospitalization for more than 24 hours. The secondary endpoint is a subset of those as well as each of the individual components of those. But I think above and beyond the primary and secondary endpoints, from a clinical practice perspective, these patient subgroups are also extremely important. And the ones that we hear most often from our steering committee and other scientific experts are the large subgroups of patients with diabetes and the secondary prevention group. And (inaudible) secondary prevention, these are patients that entered the study, having already experienced at least one primary cardiac event, either unstable angina or revascularization procedure, non-fatal MI. So those groups, from a clinical standpoint, are extremely important. And I think as we've communicated on prior calls and in the design paper which was published is that these groups are significantly sized and stratified in the REDUCE-IT study. Roughly 70% of patients enrolled are secondary prevention and there is a significant fraction of patients with diabetes that are enrolled in the study. All of the primary prevention patients, as you know, have presence of diabetes as well as other coronary risk factors. So when you think that there is a significant fraction of those with secondary prevention that have diabetes, plus a 100% of the primary prevention group have diabetes. So there is a significant number of overall patients in the study. What we hear from most of the thought leaders are those are 2 very large and important groups that are at particular risk and particular need for care beyond just LDL lowering.

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Operator [11]

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Our last question for today will be from the line of Matthew Andrews with Jefferies.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [12]

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As it relates to REDUCE-IT, assuming a positive outcome, can you talk about your thoughts on how formulary placement with insurance plans could potentially change with the potentially first and only omega-3 product to improve cardiovascular outcomes? Could it become the de facto first-line drug of choice for mixed dyslipidemia and severe high triglycerides for insurance plans. Just what are your general thoughts around how formulary placement can change and impact on potential scripts in use there? Thank you.

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John F. Thero, Amarin Corporation plc - CEO, President and Director [13]

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So I'll start this off -- I'll start the response off sort of contrasting us to something like a PCSK9. So PCSK9 comes into the market with very little or sort of really no managed care coverage as of a fairly short time ago. Positive results, but a price of $14,000 per year, and docs like the drug, it provides roughly 15% relative risk reduction, but indeed it's run into a managed care -- more than headwind, it's run into managed care wall in many places, although they are succeeding in breaking down that wall, and hopefully more and more patients who need that therapy will receive that therapy. In contrast, the coverage for Vascepa today is -- with a few exceptions, pretty strong. I think more than the managed care challenge, it's really convincing physicians that this is a patient population that should be appropriately treated. And in the cardiovascular space, many physicians are -- the preponderance of physicians are school or believe that outcomes data is how they should make their decisions. So if we have positive outcomes data, I think that's going to be -- really have a strong effect on the prescribing habits of physicians and could very well lead this to be a standard of care or first line of therapy, beyond LDL, cholesterol management in mixed dyslipidemia patients, particularly given our cost and safety profile. Are there some insurance plans and/or some individual plans under current insurers where we have coverage that -- where the coverage could improve? Absolutely, and outcomes data will -- some positive should help there as well, because those plans will look at the data today and say it's encouraging, but they're not wrong in saying it's not conclusive, the purpose of the outcome study is to make it conclusive. So I think there is an opportunity for us to increase insurance coverage, improve insurance coverage after a REDUCE-IT result, but I think the bigger opportunity is with physicians, and I just wanted to remind everybody that this really is a very different paradigm than when PCSK9s were introduced and had -- get reimbursement from the beginning, because our reimbursement that's out there today, which is predominantly Tier 2, we've always been saying, jeez, you have to have triglycerides of X or Y, the coverage is out there and strong. And if docs write this after REDUCE-IT, the coverage should be there with a few exemptions, and we will, as you suggest, work on those exceptions with outcomes data and the outcomes data should help up. Hopefully those comments are useful.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [14]

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Yes, they are. Thank you.

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John F. Thero, Amarin Corporation plc - CEO, President and Director [15]

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As the operator suggested, I think we ran out of time here, we've gone an hour. I appreciate that a number of people sent in suggested topics for questions in advance of this. Hopefully, we were able to address those in our prepared comments, so we thank you for that. We thank you for your interest. And we're going to continue to work on growing our business, based upon what we're doing today, and we obviously look very much forward to the REDUCE-IT results and to keep you appraised of our progress along the way. So thank you for your interest and support, have a wonderful day. Thank you.

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Operator [16]

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