Q4 2015 Earnings Call Transcript

Published: 25 Feb 2016

[Operator:]

Welcome to Amarin Corporation's Conference Call to discuss its Financial and Operating Results for the Fourth Quarter of 2015. This conference is being recorded today, February 25, 2016. I’d now like to turn the conference over to Kate McNeil, Executive Director, Investor Relations for Amarin.

[Kathryn McNeil:]

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 revenues, costs and other commercial metrics; gross margins, expenditures and the adequacy of our financial resources; our current expectations regarding litigation; regulatory reviews, government agency decisions and the potential for label expansion, our current expectations regarding our cardiovascular outcome study, such as timing of physician and likelihood of success. Our plan to protect the exclusivity and commercial potential of Vascepa, our goals regarding international expansion and other business development opportunities, and their current expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, February 25, 2016. 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 statement section in today's press release and the risk factors of our annual report on Form 10-K for the year ended December 31, 2015. These documents have been filed with the SEC and are available through the Investor Relations section of our Web site 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 Web site in the investor relations section. In addition to myself, on today's call from Amarin are John Thero, our President and Chief Executive Officer; Joe Kennedy, our Executive Vice President, General Counsel and Strategic Initiatives; Steve Ketchum, our Vice President of Research and Development and Chief Scientific Officer, Craig Granowitz, our newly appointed Chief Medical Officer, Aaron Berg, our Senior Vice President of Marketing and Sales and Mike Farrell, our Vice President of Finance. I'll now turn the call over to John Thero, President and Chief Executive Officer. John?

[John Thero:]

Good morning and thank you for joining us. Amarin finished 2015 strong and we’re very upbeat about 2016. During this call, we will review our 2015 results and outline our expectation for Amarin’s continued growth. Looking back, 2015 was a year of strong operational execution and significant progress. Through aggressive and nimble action, Amarin is today much stronger and better positioned than we were a year-ago. Our revenue growth is accelerated. We can promote Vascepa with expanded claims and REDUCE-IT is on track and approaching completion. Further strengthening our commercial operations was a key focus of 2015. Our progress here is evidenced by our prescription revenue growth. During the fourth quarter of 2015, we saw an increase in normalized prescriptions, based upon prescription data from Symphony Health Systems and IMS Health of approximately 52% and 55% respectively compared to the same quarter of 2014. This growth translates to $26.4 million in net product revenue from Vascepa sales, representing a 60% increase over Q4 2014. For the full-year, we achieved net product revenues of $81 million and full-year total revenue of $81.8 million, increases of 49% and 51% respectively over 2014. Broader managed care coverage, dedicated sales and marketing personnel, more than 25 scientific publications and presentations together with expanded Vascepa messaging and promotion, all contributed to our strong Vascepa revenue growth in 2015. Our expanded promotional messaging which started in August and focused on the ANCHOR lipid study results was made possible by our conviction that expanding the flow of accurate information to healthcare professionals regarding Vascepa is in the best interest of patient care. As you know, we pursued the right to such promotion through the federal court system and in August we were granted the authority we select through a federal court declaration. Since August, we’ve used this authority to further educate physicians and other healthcare professionals about Vascepa and we plan to continue this effort throughout 2016 and after. Every function of the Company has been involved in ensuring that we effectively expand our promotional messaging for Vascepa in a compliant fashion. This has been a first of a kind implementation in our industry and we’re proud of the skill, efficiency and sensitivity with which the new data has been introduced to the medical community. While we’re confident that we can continue to grow Amarin into a profitable company, based upon the current promotion of Vascepa, the potential game changer is REDUCE-IT. Assuming that REDUCE-IT is successful, it should result in a dramatic change in how patients are treated. The REDUCE-IT study remains on track both for its pre-specified interim analysis scheduled for later this year and more importantly the onset of the final targeted event in the study by the end of next year. As a reminder, the opportunity to improve patient care presented by REDUCE-IT eclipses the opportunity presented by the successful ANCHOR study as tens of millions of patients have above normal triglyceride levels after statin therapy. The number of people with high triglyceride levels is comparable to the number of people with high cholesterol. Statin therapy has demonstrated an ability in patients with high cholesterol levels to reduce cardiovascular risk by approximately one-third. This leaves millions of patients currently on statin therapy at a greater than 60% residual risk for cardiovascular disease. We envision Vascepa as being the ideal add-on therapy to statin, especially with its favorable safety profile and believe that is an opportunity that should be measured in billions of dollars. On this call, we reiterate that we anticipate 2016 revenue of between $105 million and $120 million. We believe that our revenue growth together with our continued commitment to controlling expenses, will result in our commercial operations entering 2017 cash flow positive, excluding R&D costs which are mostly related to REDUCE-IT. During 2015, we demonstrate that no challenge is too large for the Amarin team. We intend to continue this aggressive approach in 2016. I now ask Joe Kennedy, our General Counsel, to provide a brief update on our First Amendment matter leading to an update by Aaron Berg on Amarin’s commercial progress.

[Joseph Kennedy:]

Thank you, John. Our legal victories in 2015 has helped to build a strong foundation for Amarin’s continued commercial growth in 2016 and the years it follow. Of these, the most transformative for Amarin healthcare professionals and most importantly patients was the federal court declaration confirming our right to promote to healthcare professionals, the ANCHOR clinical trial data and to discuss the current state of the scientific research on the potential of Vascepa to reduce the risk of cardiovascular disease. The court order provided us with a specific set of truthful and non-misleading speech to detail the ANCHOR data and consistent with prior case law confirm the peer-reviewed publication like those outlined in the JELIS results are truthful. As the U.S Supreme Court observed in the [indiscernible] case an important First Amendment president, securing First Amendment rights is in the public interest. And that is especially so in the fields of medical and public health were information can save lives. It only furthers the public interest to ensure that decisions about the use of prescription drugs, including off label usage are intelligent and well informed. A physician courted [ph] by the Supreme Court in that case put it this way. We’ve a saying in medicine. Information is power and the more you know, or anyone knows, that better decisions can be made. These sentiments observed is a daily called arms in armory as we work to educate the medical community on the ANCHOR data and in support of, but not conclusive data relevant to the potential of Vascepa to address the significant residual risk in ANCHOR patients. As Aaron Berg will comment in a moment, physicians have expressed to us appreciation for the expanded data we’re presenting to them and for the thoughtful and balanced manner in which it is presented. Most physicians were not familiar with the data prior to Amarin’s promotion of the ANCHOR results. Our court order was a preliminary ruling. The government decided not to repeal and have carried for appeal expired in October. This leads the preliminary court ruling in place until final disposition of the case. The preliminary ruling was based in part on the judge’s favorable view of our likelihood of success on the merits, if the underlying case were to proceed to litigate the same issues through a longer process. As judge Engelmayer judging our case put it, the balance of equities in the public interest both overwhelmingly favor granting us the relief we saw in his litigation. Rather than have the underlying case proceed, since shortly after the issuance of our preliminary order, we agreed with the government to stay or halt the cases progression. And to work with the government to finalize the lawsuit through settlement terms. We believe strongly our First Amendment right to promote truthful and non-misleading information regarding Vascepa. As we’ve stated in November, our goal has been to make the preliminary order we want final and to continue on our path promoting Vascepa under the First Amendment. We remind you that suite did not seek the change FDA approved labeling for Vascepa. As previously discussed, based upon past communications with the FDA, we continue to expect the positive results with REDUCE-IT outcomes trial and a submission of a supplemental new drug application will be required for expansion of Vascepa’s labeling. Because of the nature of settlement discussions, including the need to continue to foster an open dialogue with FDA, we’re not at liberty to disclose any information about our negotiations. That includes no discussion today of the points of issue in our negotiations or the reasons for the lengthy process or expectations on when we might reach final settlement terms. As we announced last week, a joint request was submitted asking that court proceedings continue to be stayed until March 18, added before the state we will update court and investors. There are, however, four important takeaways that we like you to understand about the case at this point. First, it enables Amarin to promote Vascepa with significantly expanded claims in the context of balanced disclosures. Second, our court authority for expanded promotion continues through settlement discussion as the preliminary ruling remains in effect until final disposition of the case. Third, Amarin’s goal is to make the preliminary order final and to continue on our current promotional pattern. Fourth, if for some unexpected reason we do not come to settlement terms with the government, then we continue the underlying lawsuit, to current court order allowing Vascepa to be promoted under the First Amendment we will continue through the final disposition of the underling case. So taken together, we want you to understand that the length of settlement discussion period has had no negative bearing on our ongoing operations. We look forward to providing you with updates on this matter as event progress. I’ll now turn this call over to Aaron Berg, our Senior Vice President of Marketing and Sales to provide a commercial update. Aaron?

[Aaron Berg:]

Thank you, Joe. As John mentioned, we had strong Vascepa prescription and revenue growth in Q4. The Q4 revenue of $26.4 million which is an increase of 24% quarter-over-quarter, and 60% year-over-year, was driven primarily by an increase in prescription volume. Our year-over-year quarterly growth was strong throughout 2015, starting with 42% in Q1, 40% in Q2, increasing to 51% in Q3 and finally to 60% in Q4 of 2015. The prescription numbers from Symphony Health Solutions and IMS Health, represent growth of approximately 14% and 15% respectively compared to the quarter ended September 31, 2015, an increase of approximately 52% and 55% respectively compared to the same quarter in 2014. We believe the acceleration in prescription growth in Q4 resulted from a number of factors, some of which were building throughout 2015. These include expanded managed care coverage, positive reports of Vascepa patient experience, high level of customer engagement, low turnover and expanded education of our sales team, as well as our Vascepa co-promotion partner, Kowa Pharmaceuticals America. On top of this growing momentum, our growth in Q4 was expanded by beginning to introduce targeted healthcare professionals to the results of the ANCHOR trial and related supporting data as allowed by the August 2015 First Amendment court ruling that Joe discussed. As we detailed in our last quarterly call, there is a wealth of meaningful data that we can now share with physicians. Enrolling this information out, we’ve been mindful and strategic in our thinking about how best to introduce this information for impact and sustain retention, while also ensuring that data we promote is practical, truthful, and non-misleading. The Amarin and Kowa sales forces began by first educating select healthcare professionals on the results of the Phase III ANCHOR trial in which Vascepa, compared to placebo, improved triglyceride levels and various other lipid and lipoprotein biomarkers without increasing LDL cholesterol in statin-treated patients with persistently high triglyceride levels. This education includes promotion of published data from the ANCHOR study together with the disclosures called for by the court declaration. For most physicians, this practical information is completely new and preliminary feedback from these physicians suggest that many are appreciative of this new data and the data speak to a large percentage of patients. They comment that the information is constructive and relevant and should help them make better inform decisions regarding patient care. Many physicians are providing our representatives with additional time for more complete discussions. As we rollout this new information, Amarin sales force remains focused on the approximately 20,000 highest prescribers of prescription omega-3 products representing almost 60% of omega-3 prescriptions, gaining mindshare of this critical prescriber base continues to be a key driver of future growth. We are still early in the launch of this data and look bullishly to 2016 for meaningful effects of continued promotion. As we look to see how this early interest and engagement has impacted prescription trends, we look closely at those physicians that have been presented ANCHOR data through Q4. In this group, productivity per writer increased while Vascepa new prescription share of the prescription omega-3 market exceeded 25%. Nationally, we saw a 35% increase in the number of Vascepa prescribers in Q4 of this year compared to 2014. While our percentage penetration in the overall market for non-statin lipid lowering therapies which includes millions of patients on widely used products such as fenofibrates, is obviously much slower than that of the prescription omega-3 sector were growing with considerable remaining upside opportunity. As part of our promotion of the ANCHOR results, we’re able to educate physicians that fenofibrates are no longer FDA approved for use on top of statin therapy. As you know, fenofibrates like DHA containing omega-3 products, increased LDL cholesterol whereas Vascepa has been demonstrated to not increase LDL. With substantial data supporting that lower is better regarding LDL; we look forward to more physicians becoming familiar with the effect of this competitive therapies on bad cholesterol in the context of appropriate balanced disclosures. In conjunction with the communication efforts evolving ANCHOR, in mid Q4, we began to educate select physicians on additional relevant supporting data. Physicians have consistently been most interested in seeing outcome data related to the impact of lipid agents on cardiovascular events to assist them in making more inform treatment decisions. To address this need, and in the context of disclaimers that take into account FDA’s view and expressed in a regulatory dialogue, the Amarin sales force began educating select physicians on the results of the JELIS study. The JELIS trial was a PROBE design cardiovascular outcomes trial and was conducted in Japanese adults only. This study randomized over 18,000 patients the one of two arms, statin monotherapy or statin plus 1.8 grams of prescription EPA daily. While the product use was not Vascepa, it was a prescription EPA only product and confirmed by the FDA during our regulatory dialogue with them to be highly similar to Vascepa. The overall study achieved its primary endpoint. Statin plus prescription EPA therapy demonstrate a significant relative risk reduction of 19% in major coronary events compared to statin monotherapy. Interestingly, the Japanese consume more than five times the amount of fish and have base blood omega-3 levels significantly higher than Americans. Yet the addition of 1.8 grams of prescription EPA only omega-3 to statin, still further reduced cardiovascular risk versus statin alone in the JELIS study. Analysis of these data support our belief that EPA levels in the blood in a western population should ideally reach levels of those in the JELIS study after EPA administration. That would require daily prescription dosing of 4 grams of Vascepa which is the dose studied in Amarin and ANCHOR trials and the dose being studied in REDUCE-IT. Further, in a sub-analysis of patients in JELIS, similar to the ANCHOR patient population, those with high triglycerides and low HDL, the statin plus prescription EPA in JELIS demonstrated a 53% relative risk reduction in major coronary events versus statin monotherapy. This patient profile is very similar to the patients, our target physicians treat everyday with triglyceride lowering add-on therapies. In discussing the JELIS trial results, we emphasize that the study was conducted in Japan and provide other balanced disclosures that communicate that more study specifically the REDUCE-IT study is needed to determine the true benefit of EPA, if any, in a high risk patient population in U.S., including qualifying reasons for why outcome results could vary in the U.S. We also inform them that no outcome study has been performed in a western population of high dose prescription omega-3 or of the effect of treating patients with high triglycerides. As part of the discussion, we note of course that Amarin is conducting such study in REDUCE-IT. While promotion of the ANCHOR and JELIS trial results is expected to continue to favorably impact prescription growth, it’s far too early to know the full impact of these additional data sets. We anticipate that some physicians, despite learning the positive ANCHOR results will be hesitant to prescribe Vascepa due to perceived and with some payers real reimbursement issues associated with off-label drug use. Amarin is authorized to promote such use in physicians who are able to prescribe it. With that in mind, managed care coverage for Vascepa through Q4 was very strong with 140 million lives covered in Tier 2 and continued enhancements as we headed into 2016. In addition, over 95% of all Medicare Part D lives have unrestricted access to Vascepa. Pharmacy approvals for Vascepa confirm this access with 78% approvals across commercial and Medicare Part D payers in December 2015. This increased coverage is further augmented by our $9 copay card program to assist patients in minimizing out-of-pocket cost for Vascepa, thus further ensuring patients get the benefit of Vascepa therapy once prescribed. As we prepare for further growth and get ready for REDUCE-IT success, we recently hired a new head of managed care. Under his experienced leadership we envision the ability to continue to expand managed care coverage for Vascepa while also considering the most appropriate pricing and reimbursement strategy for Vascepa upon REDUCE-IT success. In the unexpected case that were positively surprised by early stoppage for overwhelming success, we can move quickly to capitalize on the REDUCE-IT results. Overall we’re very confident in our ability to continue to drive Vascepa prescriptions. This is a market with significant unmet need as there remain millions of statin treated patients with persistently high triglyceride and these patients need additional therapy. Our sales team is very enthusiastic. They correctly believe that what they’re doing will lead to improve patient care and its refreshing for many of them to be able to present a drug on a scientific merits and science is on our side, the more physicians gain a better understanding that pure EPA Vascepa is biologically unique and the deeper they appreciate the outstanding patient risk benefit ratio, the more inclined they will be to prescribe it. Of course, the favorable safety profile of Vascepa is part of that science. I will now turn the call over to Steve Ketchum, our President of R&D and Chief Scientific Officer to provide an R&D update. Steve?

[Steven Ketchum:]

Thank you, Aaron. As you can tell from the discussion thus far the continued timely progression of REDUCE-IT is a key priority for Amarin in 2016. So we’re pleased to once again be able to report that REDUCE-IT continues on schedule toward anticipated onset of the predefined target 1612 cumulative primary endpoint event in 2017 and publication of results in 2018. It has been more than six years since REDUCE-IT planning commenced and more than four years since we began enrolling patients in this important study. Throughout the context of this large study, we and our advisors have continued to challenge our trial assumptions. We are reassured that our core assumptions continue to hold up with event rates tracking inline with earlier predictions. This suggests to us that not only is REDUCE-IT well run and well designed, but more importantly that we’re targeting the right high risk patient population, patients who continue to have a residual risk with cardiovascular disease in excess of 60% despite statin therapy and for whom add-on therapy remains a critical mean. As you will recall, the REDUCE-IT study is designed with a composite MACE or major adverse cardiovascular event endpoint comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization or hospitalization for unstable angina caused by myocardial ischemia. The study is 90% powered to detect 15% relative risk reduction, assuming a placebo event rate of 5.2% per year. This doesn’t mean that the study won’t show a greater than 15% decrease in relative risk reduction, or that the trial couldn’t detect relative risk reduction of less than 15%, but it does mean that REDUCE-IT is well powered to detect a level of relative risk reduction with clinicians view to be clinically meaningful. If the REDUCE-IT study is successful, as we believe it will be, Vascepa will be the first in only non-statin therapy to have demonstrated a clinically meaningful cardiovascular risk reduction. Doing so in a broad based real world patient population, as has being evaluated in REDUCE-IT could result in a truly landmark change in medical care for tens of millions of patients in the U.S and internationally. As additional data and research findings become available, we find ourselves not only more confident in achieving a successful result on our primary composite MACE endpoint, but also on multiple secondary endpoints and in subgroup populations. Recent research findings continue to support the potential benefits of the EPA, the active pharmaceutical ingredient in Vascepa. For example, at the American Heart Association Scientific sessions in Orlando, Florida, on November 8, 2015, new early data from the CHERRY study conducted in Japan was presented by Dr. Kaoru Ando. He and his investigator colleagues’ conduct -- concluded from their study that compared to statin therapy alone, additional administration of EPA significantly reduced coronary plaque volume and suggested from their study results that EPA therapy may reduce the residual risk that remains in secondary prevention patients being treated with statin therapy. We look forward to publication of complete results from the CHERRY study to more fully assess the strengths and limitations of the study and the resulting data. Building on the results of higher retrospective case studies, data from two additional retrospective switch studies were presented in November 2015 at the combined annual meeting of the Obesity Society and the American Society for Metabolic and Bariatric Surgery and at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. These studies investigated the real-world effects of switching from either fibrate therapy or from EPA plus DHA therapy to EPA only omega-3 therapy on multiple lipid parameters. Results from those presentations demonstrated a reduction in both triglyceride levels and in low-density lipoprotein cholesterol or LDL-C levels in most of these high risk statin-treated patients. These two presentations add to the growing literature on the effects of EPA treatment on high risk patients with dyslipidemia, and continue to underscore our confidence in the potential benefits of Vascepa in general and in the outcome of our REDUCE-IT study specifically. In addition to the extensive data that I just highlighted, our scientific rationale for the REDUCE-IT study is also supported by mechanistic research on effects of EPA, the active ingredient in Vascepa that have not been demonstrated with other TG lowering agents or with the omega-3 fatty acid DHA. For the benefit of those who are closely tracking our progress toward the preplanned interim efficacy and safety analysis in the REDUCE-IT study, I’d like to take just a moment to provide an overview of how events are tracked and update you on our progress. Throughout the course of the study, all potential cardiovascular events are monitored, recorded and ultimately verified or as we refer to it adjudicated by a blinded review committee through a multiple step process to determine whether such potential events meet the studies pre-specified criteria and are formally considered primary events for the purpose of interim and final analysis. What this means is that over any given period, we may have a 100 or so potential primary events that are working their way through the funnel of being formally adjudicated and confirmed by the blinded clinical event committee or CEC. As you would expect this process of verifying events is time consuming with adjudication of those events often taking multiple months and only a portion of potential events confirmed as primary events. Of course this far into the study, we’ve a fairly good sense for approximately what percentage of potential events eventually get confirmed and believe we can estimate fairly accurately how many events have accrued. Based on historical data, our current estimates suggest we will have accrued approximately 60% or approximately 967 of the target aggregate number of primary cardiovascular events in the first half of 2016. However, we will not have confirmation by way of official adjudication of this event until well after the event has occurred. After that target event has been achieved and adjudicated, additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the independent data monitoring committee or DMC. As its typical for large scale multinational studies, this process is expected to take several months which should allow for the pre-specified interim efficacy and safety required at DMC to occur later this year. By doing all of the preparatory work in support of the DMC’s interim look that is expected later in 2016, we’re making the wrap up of the study at completion more efficient as approximately 60% of the key efficacy endpoint data and available safety data will have been validated and entered into the study database. Also as is typical for outcome studies and based on the design of REDUCE-IT, given the high thresholds of overwhelming efficacy and safety, and the robustness and consistency typically required to be achieved across key secondary endpoints and patient subgroups prior to an independent DMC recommending an early stop to a cardiovascular outcomes trial, we continue to believe that it is most likely that the REDUCE-IT study will run to its completion. We want the results of the study to be clearly overwhelming, before it is stalled. This is the first outcome study ever conducted in this population and we don’t want to achieve the primary endpoint, stop the study early and later learn that some key secondary endpoint was trending positively, but didn’t reach the high statistical standard for success that is associated within interim look, but that might have proven success or have the trial continue to the next year or so to completion. In the REDUCE-IT study, the independent DMC has met in close session to look at and discuss unblinded safety data on an approximately quarterly basis since study initiation in 2011. And we’ve now accumulated approximately 20,000 patient years of experience on REDUCE-IT. After each such safety review meeting to date, the DMC has recommended that the study be continued as planned. Amarin will remain blinded to the interim and ongoing results throughout the REDUCE-IT study. When later this year, the independent DMC performs the pre-specified interim analysis of efficacy and safety data, we anticipate a similar recommendation from the DMC to continue the study as planned. As enrollment of patients in REDUCE-IT is nearly complete, we’ve provided formal advanced notification of the impending closure of further patient screening to all of them more than 400 clinical study sites across the 11 countries participating in REDUCE-IT. We are working to wind down enrollment on a country-by-country basis. I will now turn the call over to Mike Farrell, our Vice President of Finance, to comment on Amarin’s fourth quarter 2015 financial results. Mike?

[Mike Farrell:]

Thank you, Steve. My comments will address Amarin’s recent financial results. You will find a more detailed discussion of these results in our 10-K and press release issued earlier today. In Q4 2015, we recognized $26.4 million in net product revenues, representing an increase of 60% as compared to net product revenues of $16.5 million in Q4 of 2014. As previously described, the timing of shipments to wholesalers may vary from period-to-period. Wholesaler inventory levels remain flat during Q4 of 2015 as compared to a previously described slight increase in wholesaler inventory levels during Q4 of 2014. On a year-to-date basis through December 31, 2015, we’ve recognized $81 million in net product revenues as compared to $54.2 million in 2014, an increase of 49%. The level of inventories held by our wholesale customers as of December 31, 2015 was slightly lower as compared to inventories held as of December 31, 2014 based on days of sales on hand. In addition to Vascepa product revenue, we recognized licensing revenue of approximately $800,000 in the year ended December 31, 2015 related to the Eddingpharm development and commercialization agreement t executed in February 2015. The development process in China through Eddingpharm continues to progress consistent with our expectations. Based on data currently available, we estimate that we will recognize net product revenues of $105 million to $120 million in 2016. This estimate is based on available historical data and trends and any significant changes in such trends could result in net product revenues that are lower or higher than our estimates and maybe variable from quarter-to-quarter. Our revenue guidance range for 2016 is somewhat broad, as we’ve less than five months of experience in 2015 promoting Vascepa, after the August court declaration allowed us to commence promotion of results of the ANCHOR study and it is difficult with such limited experience to predict the degree of impact that will have on future Vascepa prescription levels and resulting revenues. Also recall that each of the past few years, prescription levels for Vascepa and competitive drugs have experienced seasonal volatility, particularly in the first quarter. We are not at this time quantifying guidance on Q1 revenues. Our average net price per capsule sold in Q4 2015 was slightly higher than the average net price in Q3 2015, primarily as a result of lower than anticipated net rebates incurred and the effect of a 6% price increase implemented in mid 2015. Net product pricing in 2016 is expected to approximate the net selling price experienced in the second half of 2015. Cash collections from the sale of Vascepa in the year ended December 31, 2015, were approximately $114.7 million, and all of our customers remain current in their payments. Gross margin on product sales during the quarter ended December 31, 2015 was 68% as compared to 65% in Q4, 2014. Gross margin on net product sales for the year ended December 31, 2015 was 66% as compared to 62% for the same period in 2014. While our gross margin may fluctuate from quarter-to-quarter, overall we continue to expect our gross margin percentage to improve in 2016 and beyond. This anticipated improvement in gross margin reflects our ability to increasingly source slower cost API and increase purchase volumes. In Q3, 2015, we received initial batches of API from our newest supplier, and based on competitive pricing from this supplier, as well as our other suppliers, in Q4 we generated our highest gross margin to date in any quarterly period since the launch of Vascepa. From a cash flow perspective during the year ended December 31, 2015 we paid approximately $20 million more for supplier related purchases compared to the prior year. As a reminder, we began 2014 with an excess of 12 months of inventory on hand such that a portion was classified as long-term inventory on our balance sheet creating a need for minimal supplier purchases in 2014. Similar to the end of 2014, we believe that our inventory levels at the end of 2015 are right-sized to support our anticipated 2016 product revenues. Our SG&A expense in Q4, 2015 was $23.5 million as compared to $18.4 million in Q4, 2014, and was $101 million in the year ended December 31, 2015 as compared to $79.3 million in 2014. The increase in SG&A expenses was primarily driven by an increase in co-promotion expense related to our partnership with Kowa. Higher sales and marketing costs primarily associated with the August, First Amendment litigation decision permitting the Company to promote to healthcare providers, truthful and non-misleading information in regards to our ANCHOR clinical trial results, an increase in non-cash stock based compensation expense and higher legal expenses primarily associated with our New Chemical Entity and First Amendment litigation. Excluding non-cash costs and excluding co-promotion costs, our SG&A expenses were $82.5 million in 2015 and $71.9 million in 2014 with the increase primarily reflecting our expanded promotion of Vascepa. In 2016, excluding non-cash items and co-promotion fees payable to Kowa, associated with increased levels of sales, we anticipate total SG&A expenses to be held relatively flat with 2015 expense levels. Our R&D expenses in Q4, 2015 were $13.3 million as compared to $12.4 million in Q4, 2014, and were $51.1 million in the year ended December 31, 2015 as compared to $50.3 million for the same period in 2014. These expenses were largely consistent year-over-year, but historically have varied from quarter-to-quarter. The variance in R&D expenses in each period is primarily due to the timing of costs incurred in support of progressing the REDUCE-IT trial, including purchases of clinical trial materials. In 2016, we intent to manage our R&D expenses excluding non-cash amounts to a level which is relatively consistent with 2015. Under U.S, GAAP, we reported a net loss of $21.9 million in the fourth quarter of 2015. Our basic and diluted loss per share in the fourth quarter of 2015 was $0.12. This net loss included $3.7 million in non-cash share-based compensation expense, a $700,000 non-cash loss on the change in fair value of derivatives, and a $1.3 million non-cash gain on extinguishment of debt. For the year ended December 31, 2015, we reported a net loss of $149.1 million, our basic and diluted loss per share of $0.83. This net loss included $13.9 million in non-cash share-based compensation expense, a $1.1 million non-cash loss on the change in fair value of derivatives, a $1.3 million non-cash gain on extinguishment of debt, and $33.9 million in charges for non-cash deemed dividends for accounting purposes. We reported cash and cash equivalents of $107 million at December 31, 2015 representing a net decrease of $12.5 million from reported cash and cash equivalents of $119.5 million as of December 31, 2014. The net change in cash reflects a $15 million upfront payment received in March upon execution of our initial ex-US licensing agreement for Vascepa, as well as net proceeds from convertible preferred stock issuances of $57.7 million offset by cash used in operating activities. The cash balance also reflects net proceeds of $27.5 million from the issuance of exchangeable senior notes in November 2015, partially offset by the concurrent repayment of $16.2 million in existing exchangeable senior notes and related transaction fees resulting in net proceeds of $11 million. The notes that were repaid could have become due in January 2017, and were repaid at discount to the original purchase price. The earliest that the new notes can be put to the company as in January 2019 after expected completion and publication of REDUCE-IT results. Net cash outflows from operations for the year ended December 31, 2015 were $84.8 million as compared to $72.3 million in 2014. The $12.5 million increase in net cash outflow was primarily related to the previously described approximately $20 million in added supplier purchases in 2015 as compared to 2014. The cash outflows for 2015 and 2014 include approximately $41.5 million and $33.4 million respectively for R&D expenditures associated with clinical programs including REDUCE-IT and other R&D costs that do not support our existing and commercial business. It is anticipated that the company will enter 2017 cash flow positive from commercial operations excluding the R&D costs previously discussed that do not support our current commercial operations. As a result of the timing of certain items, including interest payments, supplier purchases, legal costs and REDUCE-IT expenses, we expect continued quarterly variability in cash outflows from operations. I will now turn the call back to, John Thero, for closing remarks. John?

[John Thero:]

Thank you, Mike. As I hope it’s clear by our discussion this morning, all of us remain focused on the success of Vascepa, and in turn Amarin. We have been aggressive and opportunistic in seeking the means by which to grow the company and advance the science of lipid management and cardiovascular health. This diligence was the cornerstone of our success in 2015, and will continue to guide us in 2016. We believe there is a significant opportunity in our existing indication that the full effect of our expanded marketing has yet to be realized, and that with the ever increasing body of scientific literature supporting the benefits of pure-EPA, the commercial opportunity for Vascepa in 2016 looks promising. We believe that the relentless pursuit of these opportunities will be critical drivers of our commercial business and contribute to our goal of entering 2017 cash flow positive from commercial operations excluding REDUCE-IT expenses. While this is not a small exclusion, the return on our investment in REDUCE-IT clearly has the potential to be transformative. This study is progressing well and we are excited by the prospect of becoming the first and only non-statin therapy to have demonstrated a clinically meaningful cardiovascular risk reduction. While our base case continues to be the data from REDUCE-IT will not be available until 2018. We are taking several steps now to ensure that we not only continued to be successful in our pre REDUCE-IT efforts, but that we’re also prepared to hit the ground running once the study concludes. To that end, we have made several key hires in the last several months and have another in the works. Most notably among these is the addition of Dr. Craig Granowitz, as our new Chief Medical Officer. As it’s evidenced by his successful tenure at Merck, Craig brings extensive experience managing a multinational medical affairs organization for a portfolio of leading products. Prior to joining Amarin, Craig was Senior Vice President and Head of Global Medical Affairs, Global Human Health at Merck. Not only will Craig’s extensive experience supporting and building a successful cardiovascular franchise be a tremendous asset to Amarin, it will also free Steve up to focus on the significant clinical and regulatory work that lays ahead for REDUCE-IT. We’ve also recently hired a new Head of Managed Care, who we believe can help identify new opportunities and provide critical support to our growing commercial business. In addition, as most of you already know, we recently brought Kate in full-time to lead an expanded investor relations effort for the Company. Separately, we recently initiated a search for Chief Financial Officer. While it is expected that this individual fill many needs for the company, one of these will be filling the shoes of our current Vice President to Finance, Mike Farrell who will be moving on to a new position outside the pharmaceutical industry. Mike has recently identified a unique opportunity that will allow him to apply his talents well beyond the world of public company corporate finance. While Mike isn’t leaving immediately, we wish him the best in his new endeavor and thank him for his years of dedicated service to, Amarin. All of our discussion in the call thus far seemed to have focused on the tremendous U.S. opportunity for Vascepa. As a reminder, in 2015 we started on a path to sell Vascepa in Greater China through a strategic collaboration with a leading local pharmaceutical company. Our partner, Eddingpharm, is working through the regulatory process in China, while we access partnering opportunities in other world markets and whether it is best to commence relationships there properly or weak or potentially stronger economic terms after REDUCE-IT results. Now, before we open the call to questions, I would like to thank our investors for your support. We recognize BioPharma has gotten off to a difficult start this year on Wall Street and Amarin has not been immune to this pressure. In the phase of this market weakness, we continue to be active in our outreach to current and potential investors to highlight the opportunities we see ahead in 2016 and beyond. As the turbulence in the market persists, we believe that Amarin is an attractive opportunity for investors seeking the value of a healthy and growing commercial business, combined with the significant upside potential typically associated with development stage companies. At this time, we would like to take questions from analysts and investors. Operator?

[Operator:]

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions]

[Kathryn McNeil:]

While we wait for our first question to be queued up from the operator, let’s take a question that was submitted via email. Our first question relates to the First Amendment settlement discussion and is as follows. Why is it taking so long to settle the First Amendment free speech case? Please assess any relationships or issues pertaining to REDUCE-IT interim results and TE Ando cases or other updates or other problems in dealing with the FDA?

[John Thero:]

We did cover some of that in our opening remarks, but let me turn things over to Joe Kennedy, for just a little bit of further comment.

[Joseph Kennedy:]

Okay, thank you, John. As we mentioned in our prepared remarks, we can't get into the detail on the scope and the content of our settlement discussions with respect to the First Amendment other than to reiterate that our goal is to make the preliminary order final. I can't confirm however that the settlement discussions are about the issues that were raised in the First Amendment, the lawsuit itself and not that, that other regulatory matters. For example, it’s not about a way to look at interim data on REDUCE-IT. We are committed to REDUCE-IT separately, because we think it’s the right drug in the right patient population in the right study. Its First Amendment settlement is not about a label change, the only REDUCE-IT for that based on our passed dialogue with FDA. And the First Amendment settlement is not about NCE, which is diminishing importance over time particularly in light of our patents and also because we essentially enjoy a lot of the benefits from NCE in light of some progress separately made with the FDA and through the court system such as the recent dismissal of our Ando litigation. I’ll remind you to make sure that you got the message there that we are -- we continually are able to promote under the First Amendment during and through the settlement negotiation. Thanks.

[Kathryn McNeil:]

Okay. Operator, do we have any questions that have queued up?

[Operator:]

Thank you. [Operator Instructions] Our first question from the phone comes from the line of John Boris with SunTrust Robinson Humphrey. Please proceed with your question.

[John Boris:]

Thanks for taking the questions and congratulations on the results. First question for our John and Aaron. If you look at new patient starts and switches that occurred through 2015, can you maybe just help quantify the number of new patient starts and how many of those were switches from Lovaza or Fibrate? A couple of P&L related questions, on the gross margin, you indicated it would be up but if we look sequentially at the pattern it certainly improved, you have a new supplier coming in with more favorable economics. Can you help maybe guide us towards where you think gross margins may come out? Also on tax, what are your current NOLs that you have? And then I have just one more question for, Joe Kennedy.

[John Thero:]

So, thanks John for the questions. Let me start in the middle on the gross margin one and then we’ll move on from there. So, you’re right, our gross margin product sales has been improving and then successful quarters this past year we started that -- when we started our launch, we were in the 40’s remember. Last year we started around 60 -- this -- I’d say especially in 2014 we started around 60, we moved to about 64 at the beginning in 2015 and we ended the last quarter around 68. We believe we will get into the set 70s, depending upon revenues, they all point to the mid 70s during 2016. A lot of that depends upon revenues. Some of that depends upon exchange rates as well. But the predominant factor relative to the improvement in gross margins is the competition amongst our suppliers and adding on additional suppliers. So all of our -- the cost from all of our suppliers has been decreasing. With respect to NOLs, our NOLs are about $565 million as of the end of December 2005. So clearly a significant number there which we look forward to getting profitable and being able to utilize. With regard to your first question, [indiscernible] Aaron in a moment, first person comments, but throughout 2015 we saw a strong NRx growth and we’ve just been continuing to see such strong NRx growth. We believe that a lot of this is our new patient starts, the data isn’t always clear because patients who may have been in monotherapy for wild [ph] and dropped off of therapy, you can sometimes show up as a new patient start. We’re also aware of a variety of doctors who are switching patients from existing therapy to the Vascepa. The record keeping in this area isn’t exact relative to the data we see. So some of its anecdotal, some of its static data based, but what's most important to us is that we’re seeing the NRx. Aaron, I don’t know if you have anything to add to that?

[Aaron Berg:]

No, overall around 15% from the switches, they’re switching in chronic asymptomatic diseases is a little slower. So we’re getting a lot of new patient starts, and in the new patient starts we’re getting a lot of add-ons. So the data is a little convoluted in this area but we get a lot of add-ons for statins and even add-on to other lipid agents. So, I think John, characterized it pretty well overall though.

[John Boris:]

And then, just a follow-up for Joe Kennedy related to the March 18, deadline. So you’ve been down this path with Judge Engelmayer four times, and when I read his last pre-study published and put out there on pacer it clearly indicated that this was going to be the last time. You’ve kind of soft peddled around saying that your promotion of JELIS was a select promotion on JELIS. It seems like you’re soft peddling on that promotion. It seems like it potentially could be a point of contention with the FDA since it’s the study conducted in Japanese patients. Can you maybe give some clarity as to whether that’s the point of contention that you’re trying to work through with the FDA and what would you anticipate procedurally would happen, should you not resolve this with the FDA. What would happen with Judge Engelmayer?

[Aaron Berg:]

So, JELIS promotion, I’ll just -- I’ll refer back to the opinion itself. So the opinion itself was based upon the President in Caronia. And with Judge Engelmayer observed in his opinion reasoning is that, Caronia committed off-label promotion of any FDA approved drug for any use. There was no restrictions in, Caronia. That was the reasoning he used in order to get to what was a broad growing in the final order of that case. So when we look at that and we look at the ruling itself and the focus of our litigation, which was focused on promoting to ANCHOR patients, we do use JELIS in promotion now to act as part of the supportive but not conclusive data that shows the connection of Vascepa to cardiovascular risk reduction. We’re not for example promoting JELIS in the United States with respect to its use in Japanese patients or people who have a Japanese type diet and are in Japanese level meds. So that’s the context in which we use JELIS. Okay, I’m not going to get into the back and forth pieces of negotiation, but I hope that does adjust any ambiguity that was left in the air with respect our promotion in JELIS. We are promoting on JELIS in a truthful and non-misleading way. And with respect to the processes to whether we continue -- I think the question, if I recall it correct and you’ll correct me if I didn’t, is what happens to -- with regards to process, if we do continue the litigation? It’s really up to the parties, if we could at Amarin move to, not take additional discovery and agree with the government on that, and to just move forward in the litigation based upon which typically sees the summary judgment. We agreed to all the facts, just as a matter of law is it within our rights under the First Amendment to continue the truthful and non-misleading promotion of, Vascepa. The same question that was addressed in the preliminary order, the preliminary order was the result of expedited proceedings that essentially is a system within the court that where you get down to the net ingredient short order. The underlying cases is a system where you could end up in discovery. FDA can take discovery of us with respect to matters, a hand relative to the suite. We could take discovery of FDA with respect to matters at hand relative to the suite. And so when -- shortly after the preliminary order was issued, the parties got together and thought that the rational thing to do here is to move to discuss settlement terms. I think we have to take a step back and recognize that this has been -- recognize it’s a pretty important case for FDA and they want to do things right and obviously its important case for Amarin. We want to do things right, and without getting a detail that has taken time.

[John Thero:]

Just to add on add on, I know John, you’re interested in the JELIS data. In our comments we talked a lot about how we work. We’ve taken a very thoughtful approach ensuring that the data we’re presenting is truthful and non-misleading and we do believe that the JELIS data is supportive to the ANCHOR results with that population. But just for context, at the end of the year or the end of 2015, our sales force had called on our top targets. About 25% of them wants, some of them too go ties, but we’re relatively early in the communication of that information to our targets. We have wanted to make sure that they understood the ANCHOR information first before we’re adding the JELIS information on to that. Our co-promotion partner, Kowa, as you recall they have a broader reach lower frequency than we have so more time was required to get some of the ANCHOR data out. Their sales team was thoroughly trained here in late January relative to the JELIS data. So they’re just beginning to launch that data in compliment to the ANCHOR data here recently. So, it’s still fairly early in the education of healthcare professionals with regard to that data.

[John Boris:]

That’s great color. Just one last question, I’ll hop back in the queue. On intent to prescribe in your primary market research that you’ve done with high prescribing physicians; when you layout the product concept of 19% relative risk reduction and up to 52% relative risk reduction in the population, what is coming out as far as intent to prescribe from those physicians. Is it high, medium, low? Just any …

[John Thero:]

Very high.

[John Boris:]

Very high?

[John Thero:]

Yes.

[John Boris:]

Okay. Thank you.

[John Thero:]

Anything in double digits is very attractive to clinicians that we’ve had researched through -- from.

[Operator:]

Thank you. [Operator Instructions].

[Kathryn McNeil:]

Wait, let’s turn back to some email questions for a moment while we see if there are any more questions, but I know we’re running tight on time here. We’ve received a few questions via our investor relations webpage related to the 967th event in our REDUCE-IT study. Specifically has this event already been achieved and will the company announce when the event has been achieved?

[John Thero:]

I know that comment came in before our comments here on the -- in the script, we anticipate the onset of the 967th event to occur somewhere here in the first half of 2016. As Steve described, there can be a significant time separation between the time which the event occurs and the time at which it’s formally adjudicated. Guys we have done in this call and we intent to provide regular updates on our REDUCE-IT progress. However there is variability in the adjudication process timing and the time it takes to validate all the data for the independent data monitoring committee to evaluate. And due to this variability, what we’re comfortable at this time in saying is that the 60% interim look will occur in 2016, but for time break [ph] it’s a little too broad at this point for us to be more precise in that regard. For those of you who are following Amarin back at the time we were conduction our Phase III MARINE and ANCHOR studies, you’ll remember there were questions being asked about the timing of the data analysis there. And as you’ll recall, once we have the data, we got it out quickly and we described it robustly. We certainly know that the REDUCE-IT data, it’s important to you, it’s important to us and we intend to get this data out and communicate it as quickly if possible. But relative to the specifics of timing, there’s still a lot of variables at play. And once we have clear picture we’ll try to communicate that to you as well.

[Kathryn McNeil:]

Okay. We’re going to try and hit two more of these before we wrap up, but next up we’ve got a question related to our Eddingpharm agreement, specifically asking for an update on the requirements and procedure for bringing a product to market in China? Where we are in this process, and should we expect the milestone payment in 2016 or ’17?

[John Thero:]

Predicting timing in China can be a bit tricky. Our partner who has a lot of experience there is consulting with China FDA regarding the degree to which clinical trials for Vascepa are required in China. The timeline in those requirements can vary. When we have clarity from China FDA, we’ll let you know what's required and have clearer visibility into the timeline to talk about at that point. While there is some milestones that maybe achieved in 2016 -- in 2017 under agreement. Prior to clarity on what the regulatory path is in China, it’s hard to provide more specifics on that. The milestones that are sort of before the conclusion of the regulatory paths are more modest in dollar amount than certainly than what we had when we initiated the contract. As you maybe aware China is working to shorten its backlog of responses, its response time at this point in time just very tricky to estimate. I would say that in parallel to the Eddingpharm, we are active in talking with potential partners and a variety of other different geographies. As I had commented a bit earlier, there are pros and cons to whether we do something before REDUCE-IT results or after REDUCE-IT results. I’ll take Europe for example. In Europe when -- [indiscernible] which is the name of [indiscernible] over there launch -- it was launched by different companies and different countries and therefore it has different labels, different reimbursement, different dosing. And some of the folks we are talking with would argue, let’s piggyback what's already done there and let’s get the markets quicker based upon the kinds of labels that already exist despite the lower reimbursement. Others would argue, is a much better economics for waiting and going Pan European potentially higher reimbursement rates with outcome study results. We are valuating both approaches and intent to do what we think is in the best interest of overall shareholder value. Some other geography’s aren’t quite as complicated as Europe in terms of that history of existing products in the market place, but we are actively pursuing and there is interest. It’s a matter of finding the right terms for the product, and we believe this product has a huge opportunity and we don’t want to just do a deal to get a deal done. We want to do the right deal.

[Kathryn McNeil:]

Okay. Finally, we have two questions seeking comment around our NCE status and associated Ando litigation. So perhaps, you can give everyone a brief update on this front?

[Steven Ketchum:]

Sure. On the exclusivity ramp we always need to keep in mind of course, it is our patents and not regulatory exclusivity that we see is the most important mean to maintain the exclusivity of, Vascepa. Those patents expire in 2030, and we feel very good about holding them. Some may recall we reached a point in our recently dismissed Ando litigation a while back where generics filers had to handover their alleged [indiscernible]. And we announced around and there were no issues we saw in that art that had not come up in the review, by the patent office after exhausted patent prosecutions. And for those they recall going through that with us, those prosecutions went up to the highest level at USPTO to the now [indiscernible] special application warning system program which are, for I think 0.4% of patent applications because there was a high profile public interest in that, and we will review that multiple examiners, quality assure specialists and supervisors there. And we only need one claim and one patent to get to 2030. So that’s where we look for exclusivity. We are still waiting for FDA to make an NCE determination consistent with our May 2015 winning court. But the significance of that determination has diminished, because the related progress we made with FDA and the courts that have already provided us with a lot of key benefits from NCE even without, even in the absence of an NCE determination from FDA. Specifically after our core win in May and some regulatory dialogue with FDA. FDA took the unprecedented action of unaccepting the Ando that were submitted and accepted back in 2014. And that’s due to the damn lack of an exclusivity determination after the NCE denial was set aside by the courts. The FDA also then stopped reviewing those Ando. Since then -- after that, the generics agreed to save the Ando litigation and in FDA we’re sending our exclusivity determination at unaccepting [indiscernible] that provides us with the legal basis to go back into court and ultimately win dismissal of the Ando litigation. So that dismissal happened last month. There is a notice -- one notice of appeal among the CHERRY filers that was filed before the deadline there and -- but the net result is right now there is no pending Ando litigation [indiscernible] dismissed. And though there were some challenges by generics along the way and they continue to be, what we expect they will continue to be such as watching and seeking to intervene in the NCE matter. We did defeat that effort along side FDA arguing with us in two separate courts. So the big picture is our view is now, that with the Ando litigation dismissed and no more Ando reviews, it’s now let me to resubmit those [indiscernible] after this July, which is four years after our MARINE approval back in 2012, and essentially they need to start over again. And we see those resubmissions is triggering a new 30 month stay that would expire in January 2020, all consistent with an NCE determination and that is, whether we have an actual determination from FDA or not. So we are now enjoying the benefits of NCE without an NCE determination which when that is made could itself be challenged by the generics and we’ll be prepared for that as well. So it’s proven -- all proven to be complex. Its new ground because no one has ever set aside NCE denial in court before. And so, as we work through this, we’re being diligent. We are of course disappointed that FDA didn’t make the call for NCE in the very beginning and the delays that resulted after that delays were extent now after the May court order. But since then we have been successful in [indiscernible] coming obstacles as it presented and we’ll continue to be diligent. We [indiscernible] outline these developments in our 34 filings as they’ve occurred over time and we’ll continue to do that. And there’s some summary of what I just went over today in our 10-Q as it has been in the past -- 10-K as it has been in the past and 10-Q. But again we don’t see an NCE determination as important as it once was due to progress described, and more importantly its really about those 20, 30 patents. Some has acquired I know in emails with respect to the timing for FDA as to whether they’re, when they’ll make a new exclusivity determination? We don’t have clarity from the FDA on that. We have assessed, but we don’t think its productive to go back into court to try to compel FDA to act judiciaries well as we’ve seen in the First Amendment litigation has been to actually impose things like injunctions or orders on a separate branch of government, and we think that would be expensive and time consuming and because we enjoy the benefits now we don’t see great benefit from that often pursuing that. The FDA could ultimately notify us of a new determination by letter or by just notifying that in the orange book. But we can't even be sure of which path they’ll take there, because they’ve -- their guidance in the past on this issue has been unreliable. So but we’ll let you know when it happens, and in the interim the Ando case was [indiscernible] dismissed and the associations’ decision of Ando reviews at FDA have enabled us to basically enjoy the benefits of NCE without an NCE determination.

[John Thero:]

With that said, I know we’re running to get a little bit long here and you guys have to get ready for the market to open. So I’ll wrap this call up by saying, thanks for joining us today. Your support is appreciated and we look forward to updating you on our continued progress. Good day.