Q1 2015 Earnings Call Transcript

Published: 8 May 2015

[Operator:]

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

[Michael James Farrell:]

Welcome, and thank you for joining us today. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of Vascepa sales, revenues and other commercial metrics; expenditures, supply-related activities, managed care coverage and the adequacy of our financial resources; our current expectations regarding product development internationally, government agency decisions and pending litigation; our current expectations regarding our cardiovascular outcome study, such as anticipated enrollment, the related regulatory process and potential outcomes; our plan to protect the exclusivity and commercial potential of our product; and our current expectations regarding our co-promotion agreement and our business generally. These statements are based on information available to us today, May 8, 2015. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into such as mergers, acquisitions, dispositions, joint ventures or any material agreement that we may enter into, amend or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-looking Statements section in today's press release and the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended March 31, 2015. These documents have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin, and is not intended to promote the use of Vascepa outside of its approved indication. Finally, an archive of this call will be posted to the Amarin website in the Investor Relations section. In addition to myself, on today's call from Amarin are John Thero, our President and Chief Executive Officer; Steve Ketchum, our President of R&D; Joe Kennedy, our Senior Vice President and General Counsel; and Aaron Berg, our Senior Vice President of Marketing and Sales. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

[John F. Thero:]

Good morning. Thank you for joining us today. We have made an important progress thus far in 2015. On today's call, we will discuss Amarin's recent commercial, operational and financial performance, provide an update on company initiatives and then take questions from analysts and investors. Our priorities for 2015 remain unchanged

[Aaron D. Berg:]

Thank you, John. As John mentioned, we're pleased that Vascepa revenues grew significantly in Q1 compared to the same period of the prior year, but we are clearly seeking greater growth. Vascepa revenues and prescription growth in the first quarter of 2015 was impacted by the effects of severe winter weather throughout much of the U.S., as well as by beginning-of-the-calendar year healthcare plan issues, such as new year patient deductible amounts. The exact impact of weather events is difficult to quantify, given other market variables involved. However, it appears to have had a particularly significant impact on retail pharmacy prescriptions for drugs used to treat chronic conditions. Symphony Health identified 7 winter storms during early 2015 that negatively impacted retail total prescription volumes for the entire industry at the national level. Prescription activity was affected by one or more storms in 31 states and the District of Columbia. Based on Symphony Health total prescription data, prescriptions for other drugs were adversely affected as well, including statins and hypertensive agents and oral diabetes agents. The good news, which I'll get to, is that Vascepa prescriptions achieved record highs in March. For January, Symphony Health reported that prescriptions filled in the non-statin lipid market were down 7.2% from December. For February, Symphony Health reported that prescriptions in the non-statin lipid market were down 8.5% from the already low January levels. Vascepa prescriptions were also down in January and February, but not to the same extent. In March, based on Symphony Health data, Vascepa new prescriptions grew 14.1% over the December high, while Vascepa normalized total prescriptions rebounded in March to achieve 5% growth from Q1 overall versus Q4 of 2014 and 66% growth over Q1 2014. Vascepa prescription growth continues to be primarily generated for higher decile physicians targeted by both Amarin and Kowa sales representatives. We believe that Vascepa can grow considerably further 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. As we've noted, the FDA has decided not to approve our proposed expanded indication for Vascepa based on the results of the ANCHOR study. FDA acknowledged that Vascepa yielded a treatment difference against placebo in the patient population studied in the ANCHOR study and urged us to complete the REDUCE-IT cardiovascular outcome study pointing to final REDUCE-IT data as a means to settle FDA's uncertainty on the connection between triglyceride reduction and cardiovascular outcomes in the ANCHOR population, specifically those patients with persistently high triglycerides after statin therapy. Unfortunately for patients in the interim, under FDA regulations, because FDA decided not to approve any form of our ANCHOR sNDA, Amarin's prohibited by the FDA from freely communicating to healthcare professionals known truthful and non-misleading information about Vascepa such as the ANCHOR clinical data relevant to how doctors can meet clinical guideline recommendations and potentially achieve additional cardiovascular risk reduction. While certain physicians are aware of the results from medical inquiries and other restricted means of communication, most physicians are unaware of the ANCHOR results. This is especially problematic since fenofibrates and prescription niacin, which are widely used to treat patients with high triglycerides, have failed in cardiovascular outcome studies that focused on patients, including some with persistently high triglycerides. These products, along with DHA containing omega-3 products, have certain unwanted effects not associated with Vascepa, as has been evident in their FDA-approved labeling. Available scientific evidence reflects that EPA may have benefits within cardiovascular disease beyond triglyceride-lowering not evident with other drugs. FDA's regulations prevent the free communication of important information to inform clinical practice and prevent doctors from getting information about a viable treatment alternative possibly better suited for specific patients. We believe that knowledge of this information by healthcare professionals could improve patient care. This is also particularly true given that the direction of certain doctors or pharmacists, patients turn to dietary supplements to treat their high triglycerides. These products are not required to demonstrate efficacy or safety and most commonly have low levels of omega-3, have unknown manufacturing quality and contain DHA, which has been associated with increases in LDL cholesterol in patients with high and very high triglyceride levels. This is such an important public health issue that on March 26, the American Pharmacists Association held a "clarity for patient care roundtable" to discuss the health implication of this problem and how to best further consumer, prescriber and pharmacist education on this issue. After that session, they've made efforts to warn their constituents and other healthcare professionals to not use dietary supplements to treat serious medical conditions such as elevated triglycerides. In late-April, FDA-revised labeling for certain triglyceride-lowering drugs, including fenofibrate products, such as Trilipix, and the prescription niacin product, Niaspan, to remove from their labels the use of these drugs on top of statin therapy. As a result, these therapies are no longer approved for treatment of mixed dyslipidemia to augment statin therapy. This action follows failed outcome studies for these therapies, as published in prior years. Both of these drugs have been promoted and used for years and continue to be used to treat high triglycerides in combination with statins. Fenofibrate and niacin drugs are now generic, and it's unclear the extent to which healthcare professionals will become aware of these label changes. These label changes by the FDA are consistent with Amarin's messages regarding Vascepa that drug therapy used on top of statins should be well-tolerated, safe and not work against the benefit statin therapy. Key elements of our anticipated Vascepa growth for the balance of 2015 are

[Joseph T. Kennedy:]

Thank you, Aaron. As John and Aaron noted, FDA's decision to not approve any form of our ANCHOR sNDA, which included a decision to not approve the addition of ANCHOR efficacy data in current Vascepa labeling, has created a real problem for the care of patients with persistently high triglycerides after statin therapy. Using drugs like Vascepa to treat these patients is commonplace in medical practice. Doctors choose to lower patients' lipid levels based on their own expert medical judgment and with guidance from multiple national and international treatment guidelines and physician statements. A decision to treat is filed by the need to decide among available treatment options. That decision is based on clinical data and scientific evidence known to the doctor. For the years before Vascepa was available, doctors treated these patients with fenofibrate and niacin products and then Lovaza, and of course, continue to do so. As Aaron explained, in late-April, contemporaneous with the issuance of our ANCHOR CRL, FDA withdrew indications and data from labeling of fenofibrate and niacin products related to the treatment of patients studied in the failed outcomes trials, ACCORD-Lipid from 2010 and AIM-HIGH from 2011. As additional information for investors, we've included in the Frequently Asked Questions section of our Investor Relations website an overview of Amarin and FDA's views on those studies, as well as on the HPS2-THRIVE study and on the JELIS cardiovascular outcomes trial of EPA in Japan, each as discussed publicly over time and, in particular, since FDA's October 2013 ANCHOR advisory committee meeting. Fenofibrate and niacin drugs are still widely used for treatment of patients with persistently high triglycerides, despite years ago, having failed in cardiovascular outcomes trials that included some patients with persistently high triglycerides. Similarly, Lovaza data in the high triglyceride, despite statin therapy patient population, was withdrawn from labeling by FDA in May 2014. Each of these drugs has significant safety concerns and side effect profiles not associated with Vascepa. Despite the labeling revisions, doctors are familiar with the effects of these drugs, as they were lawfully detailed for many years. Our ANCHOR Phase III clinical trial results were announced publicly in April 2011, over 4 years ago. But under FDA regulations, we cannot freely communicate known, truthful and non-misleading information about ANCHOR study in a promotional setting with doctors without violating FDA regulations and the very real possibility of potential criminal prosecution of Amarin's employees and significant civil liability under the False Claims Act. That is because FDA forbids promotion of drugs for unapproved or so-called off-label uses. That's the case even if the promotional use of data are unquestionably truthful and presented in a non-misleading manner, and even if the promoted use is within accepted medical practice and recommended by guidelines. By controlling the flow of information, FDA significantly affects what drugs doctors prescribe and thus, the practice of medicine and the treatment of patients. In this case, we believe the restricted flow of the information negatively affects patient care. Amarin's cardiovascular outcome study of Vascepa in REDUCE-IT is ongoing. As FDA has acknowledged in regulatory dialogue in the context of the JELIS trial of EPA in Japan, the effects of EPA that may contribute to cardiovascular risk reduction may not be limited to triglyceride-lowering alone and other effects demonstrated in the ANCHOR trial. The physiological effects of omega-3s in the body that may contribute to the reduction of cardiovascular risk have been explored in scientific literature, but have not been fully elucidated. Peer-reviewed published data suggests that these effects of EPA may go beyond triglyceride-lowering. For example, hardening of the arteries, or atherosclerosis, is a primary underlying process of cardiovascular disease involving oxidative stress, inflammation, cell dysfunction and cholesterol accumulation within the arterial wall. That is followed by the formation and progression of plaque, which can eventually become unstable and rupture, leading to heart attack and stroke. Research has shown that EPA may reduce atherosclerotic burden by improving many aspects of the lipid profile and by improving various parameters within arthroscopic plaque. Studies have also suggested that EPA may have beneficial effects on arterial function, heart rate, blood pressure, blood clotting and cardiac function in rhythm. Based on data consistent with the above, for more than a decade, FDA has permitted dietary supplement manufacturers that sell supplements containing EPA and/or DHA to make the following qualified health claim directly to lay consumers. Supportive, but not conclusive, research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. This health claim was approved by FDA in 2004 before the encouraging JELIS outcomes trial of pure EPA in Japan. But if Amarin's pharmaceutical sales reps made this statement, same truthful and non-misleading statement to sophisticated doctors about Vascepa, which consists of pure EPA, those pharmaceutical sales representatives and Amarin could be subject to criminal charges for massive civil liability under FDA's regulatory structure. Thus, like the ANCHOR data, pre-communication about the state of research on omega-3s and other potential effects of EPA, the healthcare professionals are also off-label and prohibited from being freely communicated to healthcare professionals in promotion of Vascepa. This leads most physicians making decisions regarding the treatment of their patients with elevated triglyceride levels with incomplete information regarding treatment options. We must ask ourselves if data are accurate, fairly presented, why should doctors have restricted access to it? We believe patient care is best served when doctors are fully informed on available treatment options. We believe making it illegal to share data freely and proactively, in our case, does not help patients; it hurts them. We don't know yet whether Vascepa will reduce cardiovascular risk in the REDUCE-IT study. But every day across America, doctors need to make choices among available treatment options for patients with high triglyceride beside statin therapy. Ready access to accurate information of Vascepa will help doctors make these informed choices. Last night, we filed a lawsuit in federal court in New York with the second Federal Circuit to permit Amarin to share truthful and non-misleading information with healthcare professionals in the United States that would be considered off-label by the FDA. It's important to highlight that a lawsuit does not seek to offend FDA's regulatory structure and the judgment requested would not. It does ask the court to make what's known as a judicial declaration, to declare only as implied to Amarin's promotion of Vascepa in this case that FDA regulations limiting off-label promotion are unconstitutional under the First Amendment's freedom of speech principles, or the Fifth Amendment's restriction against state laws. This would allow Amarin to promote the ANCHOR data, make the referenced qualified health claim with respect to Vascepa and share peer-reviewed publications on the potential effect of EPA on cardiovascular risk, together with appropriate disclaimers to ensure that truthful information communicated is not misleading, including that the effect of Vascepa on cardiovascular risk has not been determined and that FDA has not approved Vascepa for use described in the ANCHOR study or for cardiovascular risk reduction. If we win at the district court level, we expect to be able to promote the requested data during any period of appeal by FDA. We believe our request for judicial declaration falls squarely within the landmark Second Circuit President of the United States v. Caronia, in which the Second Circuit Court of Appeals reversed, on First Amendment grounds, the lower court's criminal conviction of a pharmaceutical sales representative based on his truthful and non-misleading off-label promotion. We have been urged by many physicians to pursue lawful promotion of the subject accurate information and are joined in our lawsuit by a number of individual physicians who strongly support this effort; and as our suit contends, our First Amendment rights to receive truthful and non-misleading information from Amarin. If past history is a guide, we expect the FDA will have its own very strong positions, which we expect to play out in court over the next 6 to 9 months. It is too early at this stage to provide any guidance on timing for an outcome. This is a somewhat unique case in this area of law, as most arguments of this nature have been made in response to FDA enforcement action. There are no increase or allegations of any wrongdoing against Amarin from FDA or any governmental entity on this topic. We remind you that the outcome of litigation is difficult to predict and we can make no assurance that the outcome will be positive for Amarin. The suit does not change Amarin's priorities, as John described them. Our focus remains on increasing Vascepa's prescription growth based on the current approved Vascepa indication and on progressing REDUCE-IT to conclusion as quickly as possible. With that, I welcome Mike Farrell, our Vice President of Finance, to comment on Amarin's first quarter 2015 financial results. Mike?

[Michael James Farrell:]

Thank you, Joe. My comments will address our recent financial results. You will find a more detailed discussion of our results in our 10-Q and press release issued earlier today. In the first quarter of 2015, we recognized $15.6 million in net product revenues, representing an increase of 42% as compared to net revenues of $11 million in the first quarter of 2014. Net revenues in the first quarter of 2014 include approximately $1 million in previously deferred revenues related to a change in our revenue recognition methodology from the sell-through to the sell-in method. We also recognized $400,000 in licensing revenue from our China collaboration during the first quarter of 2015. As previously described, the timing of shipments to wholesalers vary from period to period. At the end of March, wholesalers held approximately 4 days fewer in inventory than they held at the end of December. We view this to be more of a matter of timing and not an ongoing trend. You may recall that during 2014, we commented that in some quarters, wholesalers increased inventory levels. And in other quarters, their inventory levels declined. The largest wholesalers purchase most of their product once per week, and smaller wholesalers sometimes purchase less frequently. Depending upon the timing of orders and the timing of shipments, their average inventory levels vary. Our average net price per capsule sold in the first quarter of 2015 was slightly lower than our average price in the fourth quarter of 2014 as a result of additional rebates due to expanded commercial coverage and improvement in formulary position, partially offset by the price increase implemented in mid-November 2014. For the first quarter of 2015, this resulted in a reduction in Vascepa product revenues of approximately $400,000. Our overall rebate levels remain consistent with industry practice, but utilization of such rebates has been higher with expanded Tier 2 coverage. We believe that such expanded Tier 2 coverage contributes to increased prescriptions. Cash collections from the sale of Vascepa in the quarter ended March 31, 2015 were approximately $21.5 million, and all of our customers remain current in their payments. Gross margin on product sales during the quarter ended March 31, 2015 was 64% as compared to 61% in the first quarter of 2014. While our gross margin may fluctuate from quarter-to-quarter, overall, we expect our gross margin percentage to improve as we source lower-cost API. We began purchasing an increasing proportion of lower-cost API during 2014 and anticipate that purchase costs will continue to fall on average based on supplier mix, purchase price concessions and the improved strength of the U.S. dollar as it relates to foreign exchange rates. Our SG&A expense in the first quarter of 2015 was $24.7 million as compared to $20.6 million in the first quarter of 2014. The 20% increase in SG&A expenses was driven by quarterly variability in legal expenses as well as co-promotion expense of $1.5 million related to our partnership with Kowa, which did not commence until the second quarter of 2014. Other than anticipated growing costs for Kowa's co-promotion and the timing of legal costs, our intention is to keep 2015 SG&A expenses generally consistent with 2014 levels while growing revenues. Our level of expenses will be variable from quarter-to-quarter, and we do not plan significant increases in our sales and marketing spend until supported by considerably higher revenues. Our R&D expenses in the first quarter of 2015 were $12.6 million as compared to $11.7 million in the first quarter of 2014. The increase in R&D expenses compared to 2014 was primarily driven by quarterly variability in costs associated with the ongoing REDUCE-IT trial. R&D costs are expected to be slightly higher during 2015 as compared to 2014 as a result of the timing of REDUCE-IT costs. And such costs are expected to decline modestly thereafter upon completion of enrollment for REDUCE-IT. Under U.S. GAAP, we reported a net loss of $32 million in the first quarter of 2015. Our basic and diluted loss per share in the first quarter of 2015 was $0.18. This net loss included $3 million in noncash share-based compensation expense, a $500,000 noncash gain on the change in fair value of derivatives and a $900,000 charge for a noncash gain dividend for accounting purposes, the reported cash and cash equivalent of $161.2 million at March 31, 2015, representing a net increase of $41.7 million from reported cash and cash equivalents of $119.5 million as of December 31, 2014. During the first quarter of 2015, cash inflows included a $15 million upfront payment received upon execution of our initial x U.S. licensing agreement for Vascepa, as well as net proceeds of $52.2 million from the issuance of convertible preferred stock. Net cash outflows from operation, excluding the $15 million in proceeds from the upfront licensing fee, were $27.6 million in the first quarter of 2015 as compared with $27.5 million in the first quarter of 2014. As a result of the timing of certain items, including interest payments and the timing of supply purchases, legal costs and REDUCE-IT expenses, we expect quarterly variability in 2015 cash outflows from operations. On the Investor Relations front, Amarin will be presenting at the 2015 Jefferies Healthcare Conference in New York City during the first week of June. I will now turn the call back to John Thero for closing remarks. John?

[John F. Thero:]

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

[Operator:]

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

[John T. Boris:]

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

[Operator:]

[Technical Difficulty]

[Operator:]

Now rejoining the speakers.

[John F. Thero:]

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

[Operator:]

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

[John T. Boris:]

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

[Aaron D. Berg:]

Thanks for the multipart questions. Let me answer all the pieces of them, the one I'm going to throw to Joe Kennedy there first. So with regard to your questions on the overall space, the comments that we were attempting to make in the call were to reflect that in January and February, that prescriptions broadly, particularly prescriptions for drugs addressing chronic use, declined; it included diabetes drugs, it included others. But we -- particularly because it's most applicable to us wanted to reference statins and other sort of certain non-statin lipid-modifying drug, which includes the fenofibrates and the niacin. Based upon the data that we have seen, and this is through Symphony Health Solutions, those prescriptions or those therapies dropped in January and then in February, but like ours, increased again in March. Fortunately, ours didn't go down quite as much as the overall industry. And I'm not singling out individual drugs here. We don't have it drug by drug. I'm just looking at the categories as supplied to us by Symphony Health. We didn't decline as much as they did in January and February. And in March, they were up, but we were up further, again versus the entire category. We presented that not as sort of market commentary on physician use of other therapies or switches of other therapies, but rather on overall trends as it relates to topics like the severe winter weather and the fact that a lot of medical insurance plans have put our x's under the medical health benefit, which then subject them to the annual deductible. And there's others of procedural issues that start a year off. And last year, we had some sluggishness, as I think I referred to it in my comments in the first quarter, clearly had sluggishness here. It appears to be industry-wide. I'm hearing from CEOs of other companies that this isn't unique. We're encouraged by our market results. We continue to be encouraged here as we get into Q2 as well, although I'm not going to comment specifically on Q2 performance. But we do feel strongly that the primary issues, as it relates to Q1, are behind us, and we're moving forward on that. We have been continuing to hear from physicians that patients are switching from other therapies to Vascepa. Obviously, we need to have more of that happen, but the commentary here about levels and trends was really much more a reflection of Q1 anomalies than it was on a broader topic. With regard to coverage, we have been making progress on that. I don't have the quantified numbers in front of me, but the big wins we have, for example, Aaron Berg mentioned were effective in May on parity at Humana with Lovaza. Generic, we had multiple wins here that are going into effect in May and some others in July. And we will be providing further updates as we move along. I think we have quantified in the past that our coverage has been good. It remains good. We've not lost anybody in terms of our coverage. We're adding to it. There have been some sticklers relative to getting coverage in Humana, particularly as it relates to Medicare Part D, has been a form for us historically because it -- to the extent that they weren't providing coverage, it has the larger shadow. Physicians will look at that as being a representative of other payers even if they haven't gone to other payers just because of the size of Humana, particularly in certain geographies of the country and removing that particular obstacle directly, but also removing that shadow that gets cast from it, we think will be positive. With regard to Eddingpharm, the -- actually met with Eddingpharm initially about 4 years ago at a JPMorgan conference. So it wasn't as though we've started off discussions with Eddingpharm recently. We did tighten our interaction with them after we shifted our focus to international expansion following our mid-2014 conclusion of our domestic co-promotion deal with Kowa. And we focused on China first due to its market size and the growing opportunity there. We are looking at other international opportunities. They are all unique. They -- and we are talking -- in each of the other geographies that we're looking at, we are talking with multiple companies. They are -- none of those geographies are quite as direct as what we saw with China. For example, in Europe, it is somewhat cluttered by the fact that when Omacor/Lovaza was launched in Europe, it was launched by multiple companies and, as a result, has multiple indications, has different indications in different countries and different reimbursements in different countries. And there are various strategies that we're evaluating, both ourselves and with potential partners, as to what the best approach is to Europe. In other geographies, there are other complications. So there is interest. There is activity. But whenever we're talking about partnering opportunities where we're looking for long-term commitments from companies, it is our objective to find the right company for a long-term successful partnering deal, not just take a deal because it's presented to us. So when we get to the point where we feel as though we have those right deals, we will announce them, but we're not providing any guidance on the specific terms or the timing of those transactions. I can tell you there's interest, but beyond that, we don't want to set any expectations for an immediate result. It's possible, but we want to be right more than we want it to be fast. So with that, I'll turn things over to Joe Kennedy for your -- the fourth part of your question.

[Joseph T. Kennedy:]

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

[John F. Thero:]

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

[Operator:]

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

[John F. Thero:]

Yes, I appreciate it. It's 9

[Operator:]

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