Q3 2015 Earnings Call Transcript

Published: 4 Nov 2015

[Operator:]

Welcome to Amarin Corporation's Conference Call to discuss its Financial and Operating Results for the Third Quarter of 2015. This conference is being recorded today, November 4, 2015. I’d now like to turn the conference over to Mike Farrell, Vice President of Finance for Amarin.

[Mike 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 plans to protect the exclusivity and commercial potential of our product; and our current expectations regarding our co-promotion agreement and our business generally. These statements are based on information available to us today, November 4, 2015. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially. So, you should not place undue reliance on these statements. We assume no obligation to update these statements if circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreement that we may enter into, amend, or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statement section in today's press release and the risk factor section of our quarterly report on Form 10-Q for the three and nine months ended September 30, 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; Steve Ketchum, our President of R&D; Joe Kennedy, our General Counsel; and Aaron Berg, our Senior Vice President of Marketing and Sales. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

[John Thero:]

Good morning. Thank you for joining us today. Many things have being going well for Amarin in recent months. Hopefully that’s clear from the press release we issued this morning. In this conference call, we will discuss Amarin's recent commercial, operational, and financial performance; provide an update on important Company initiatives and legal matters; and then take questions from analysts and investors. Our priorities for 2015 remain unchanged

[Aaron Berg:]

Thank you, John. As John mentioned, we’re pleased that Vascepa prescriptions and revenues grew meaningfully in Q3. The prescription numbers from Symphony Health Solutions and IMS Health, as cited by John, represent growth of approximately 13% and 12% respectively compared to the quarter ended June 30, 2015, an increase of approximately 51% and 56% respectively compared to the same quarter in 2014. We experienced growth throughout Q3, starting in July. In August 2015 as previously announced the United States District Court granted Amarin’s request under the First Amendment for preliminary release and confirm that Amarin may engage in truthful and non-misleading speech promoting Vascepa to healthcare professionals beyond the use approved by the FDA, with specific reference to patient studies in Amarin successful ANCHOR study of Vascepa and patients with persistently high triglyceride after statin therapy, and that such speech may not form the basis of a misbranding action under the Federal Food and Drug Cosmetic Act. While not the same as a label change, and specifically not an indication for the use of Vascepa in patients with high triglycerides between 200 and 499 mg/dL, the court declaration allows promotion of the FDA reviewed and agreed upon effects of Vascepa demonstrated in the Phase 3 ANCHOR clinical trial and use of peer-reviewed scientific publications that present the current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease. We believe that this Federal Court decision and resulting education about the ANCHOR results, will lead to improved patient care as it opens more direct and effective paths to communicate truthful and non-misleading information. With accurate information readily available, healthcare professionals will be better able to decide for themselves how best to choose among available treatment options for their patients. As a result, beginning in mid August the Amarin and Kowa sales forces began educating select healthcare professionals on the lipid and lipoprotein results of the 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 certain disclosures as described by Amarin at the time of the Court declaration. We intend to begin promotion of additional relevant data regarding effectively treating patients with high and very high triglyceride after targeted healthcare professionals become more aware of the first set of new data. While its too early to assess the impact of educating physicians regarding ANCHOR trial results, preliminary feedback from healthcare professionals suggest that they appreciate the information and as for most of them the information is completely new, while promotion of the ANCHOR trial results, they’ve had some positive impacts on September prescription levels, the level of such impact is believed to be relatively limited. 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. We are bullish regarding the value of this added data that we’re now able to communicate to professionals, but it’s too early in the launch of this new data to accurately quantify the future impact of such expanded promotion on Vascepa prescription growth. For the avoidance of doubt, the information we’re communicating to healthcare professionals under authority of the court’s decision, its truthful information and great care has been taken to communicate the information fairly, so that healthcare professionals are not mislead. For example, FDA has reviewed the efficacy and safety results of our ANCHOR data. And the safety data from ANCHOR is already reflected in our approved label. The FDA confirmed that they’ve no disagreement with the accuracy of the efficacy results reported from this Phase 3 study. FDA has emphasized that they have a higher level of proof required for a label change than it is relied upon by physicians in their daily practice of medicine. We also remind you that FDA has strongly urged us to complete the REDUCE-IT cardiovascular outcome study, pointing to final REDUCE-IT data as a means to potentially settle FDA’s uncertainty on the connection between triglyceride reduction and cardiovascular outcomes in the ANCHOR population, specifically, illustrations with persistently high triglyceride after statin therapy. Remember that these patients are often treated by other therapies, which have unwarranted [ph] side effects not associated with Vascepa. However, very few healthcare providers are aware that we are conducting the REDUCE-IT cardiovascular outcome study. Physicians have been asking for this type of information and we’re now able to share this important information with key target providers. In order to ensure fair balance, all such communication includes disclaimers and other steps to ensure that the scientific information communicated is truthful and non-misleading. Some investors have asked why we are not immediately promoting to physicians all available truthful data covered by the First Amendment court decision? The short answer is that we’re focusing on quality over quantity. We will get to additional information such as [indiscernible]. But first we want to ensure that our target physicians understand the top line ANCHOR trial results. Physicians have a lot to remind, so if we take a short cut approach of communicating too much new scientific information to them all at once, they are less likely to remember the information. Study show that it takes multiple visits with physicians to get them to understand information and to act on it. During Q4, we intend to begin talking to target physicians about the next module of data. Again, we are taking a very thoughtful approach to ensure that physician understand the data we present to them. Of late, there has been increased emphasis on the need to manage LDL cholesterol levels. Vascepa is not a drug intended for LDL management. However, Vascepa data remains unique among key competitive products in demonstration of Vascepa’s ability to lower triglyceride and a host of other lipid measures without increasing LDL cholesterol. PCSK9 inhibitors have been part of the recent discussion on the value of the lowering LDL cholesterol due to their ability to prevent PCSK9 from reducing LDL receptor levels, thereby providing a new means to lower LDL. Few are aware that broadly used with the lowering agents, such as fenofibrates, have been reported in the scientific literature to increase PCSK9 levels. Fenofibrates are generic and are no longer actively promoted, but they are widely used. And fenofibrates like Niacin are no longer labeled for use as add on to the statin therapy as of earlier this year. So while there are new injectable therapies to lower blood PCSK9 levels and subsequently lower LDL-C, clinicians should first make sure to address lifestyle habits and drug therapies that may have an adverse effect on LDL levels. Our experience in the field is that Vascepa works as demonstrated in our trials. We are in the early stages of promoting new and important ANCHOR trial data to select physicians and we will be expanding our messaging as we move forward. Our commercial team looks optimistically at the balance of 2015 and beyond. I'll now turn the call over to Steve Ketchum, our President of R&D to provide an R&D update. Steve?

[Steve Ketchum:]

Thank you, Aaron. REDUCE-IT, the first perspective cardiovascular outcome study to evaluate the effect of a 4-gram dose of a pure-EPA prescription omega-3 in patients who despite statin therapy have elevated triglyceride levels continues on schedule toward anticipated completion in 2017 and publication of results in 2018. To date approximately 7,800 patients have been enrolled representing more than 97% of total targeted patient enrollment. Completion of REDUCE-IT is event driven and depends on attainment of 1,612 cumulative patients with documented primary cardiovascular events. The REDUCE-IT cardiovascular event rate continues to track to our expectations for the protocol pre-specified interim efficacy and safety look by the independent Data Monitoring Committee or DMC, to occur in 2016 upon reaching 60% of the target aggregate number of cardiovascular events. Given the high thresholds of overwhelming efficacy and safety typically required to be achieved prior to an independent DMC recommending an early stop to a large long-term cardiovascular outcomes trial like REDUCE-IT, management continues to believe that it is most likely that the REDUCE-IT study will run to its completion. It is most common for large long-term outcome studies of cardiovascular therapy to not be stopped early. Most cardiovascular outcome studies conducted over the past decade or so have run to completion. These studies included interim looks by independent DMC's for both efficacy and safety, but were not stopped early. If the REDUCE-IT study is not stopped early in 2016, this should not be a surprise to anyone and should in no way be interpreted to suggest that this study is not positioned for success. 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 after each such meeting the independent DMC has recommended that the study be continued as planned. Amarin remains blinded to REDUCE-IT study data. When the independent DMC performs to pre-specified interim look at all available efficacy and safety data in 2016, we anticipate a similar recommendation from the DMC to continue the study as planned. While Amarin is blinded to the ongoing study results, based on comprehensive review of clinical, epidemiological, and genetic data, Amarin continues to believe that REDUCE-IT is well positioned for success. The result of this important trial could lead to improved medical care for tens of millions of patients. Recent research findings continue to support the potential benefits of EPA, the active pharmaceutical ingredient in Vascepa. Building on the result to prior retrospective case studies, data from a retrospective switch study was presented at the American Society for Preventive Cardiology Annual Cardiovascular Disease Prevention Conference, in August. This study investigated the real-world effect of switching from EPA plus DHA therapy to EPA only omega-3 therapy on multiple lipid parameters. Results demonstrated a reduction in both triglyceride and low-density lipoprotein cholesterol or LDL-C levels in most of these high risk statin-treated patients. Data from an ANCHOR trial sub-analysis was presented in August at the current Lipid Conference. This sub-analysis examine the effect of EPA on high-risk statin-treated patients with persistently high triglyceride levels, showing that icosapent ethyl increased EPA in plasma and red blood cells in a linear, dose-dependent fashion consistent with its triglyceride-lowering effect. These two presentations add to the growing literature on the effects of EPA treatment on high-risk patients with dyslipidemia. Additional study has been conducted in the REDUCE-IT cardiovascular outcomes trial is needed to determine the extent to which if any, the effects of EPA shown in these studies would have clinically meaningful benefit. I will encourage investors to review the dozens of clinical epidemiological and genetics study references on our corporate Web site, which support our confidence in REDUCE-IT success. I'll now turn the call over to Mike Farrell, our Vice President of Finance, to comment on Amarin’s third quarter 2015 financial results. Mike?

[Mike Farrell:]

Thank you, Steve. 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 Q3 2015, we recognized $21.3 million in net product revenues, representing an increase of 51% as compared to the net product revenues of $14.1 million in Q3 of 2014. As previously described, the timing of shipments to wholesalers vary from period-to-period. However, wholesaler inventory levels largely remain flat during Q3 of both 2015 and 2014. On a year-to-date basis through September 30, 2015, we’ve recognized $54.6 million in net product revenues as compared to $37.7 million in the same period in 2014, an increase of 45%. Note that our year-to-date net product revenues through nine months of 2015 exceeded our full-year net product revenues for 2014. Based on data currently available, we estimate that we will recognize net product revenues of $22.5 million to $24 million in the fourth quarter of 2015 resulting in net product revenues of $77.1 million to $78.6 million for the year ended December 31, 2015. 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. Vascepa revenue growth remains difficult to predict. We are very early in our promotion following the First Amendment court decision and patients who might benefit from Vascepa treatment typically have physician appointments only once a year. We believe that our product revenues will continue to grow, but that such growth will be variable from quarter-to-quarter. We believe that we can grow an attractive and sustainable business based on the current label and promotion of Vascepa, while we looking forward to significantly greater growth following assumed REDUCE-IT study success. Our average net price per capsule sold in Q3 2015 approximated our average net price in Q2 2015. Cash collections from the sale of Vascepa in the nine months ended September 30, 2015, were approximately $78.2 million, and all of our customers remain current in their payments. In addition to Vascepa product revenue, we recognized licensing revenue of $500,000 in the nine months ended September 30, 2015 related to the Eddingpharm development and commercialization agreement t executed in February 2015. The development process in China continues to progress, consistent with our expectations. Based upon our current estimates, we anticipate approximately $800,000 in licensing revenue will be recognized in aggregate during 2015, including the $500,000 recognized through September of 2015. Gross margin on product sales during the quarter ended September 30, 2015, was 65% as compared to 62% in the third quarter of 2014. Gross margin on net product sales for the nine months ended September 30, 2015 was 64% as compared to 61% for the same period in 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. In Q3, we received initial batches of API from our newest supplier. We anticipate based on competitive pricing from this supplier, as well as our other suppliers, gross margin should continue to improve, particularly, as we progress through 2016. During the nine months ended September 30, 2015 we paid approximately $26 million for supplier related purchases compared to approximately $6 million paid in the same period of the prior year. As a reminder, we began 2014 with an excess of 12 months of inventory on hand, such that a portion is classified as long-term inventory on our balance sheet. Our SG&A expense in Q3, 2015 was $26.7 million as compared to $19.3 million in Q3, 2014 and was $77.5 million in the nine months ended September 30, 2015 as compared to $60.9 million for the same period 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 recent 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 as well as higher legal expenses primarily associated with our new chemical entity and First Amendment litigation. During Q3, 2015 we initiated extended marketing programs in order to communicate broader information about Vascepa to healthcare professionals than we have previously communicated, including information about the results of our ANCHOR trial. Our R&D expenses in Q3, 2015 were $13.1 million as compared to $14.5 million in Q3, 2014 and were $37.7 million in the nine months ended September 30, 2015 as compared to $37.9 million for the same period in 2014. The variance in R&D expenses compared to 2014 was primarily driven by the timing of costs and support of progressing the REDUCE-IT trial including purchases of clinical trial materials. Under U.S GAAP we reported a net loss of $32.3 million in the third quarter of 2015. Our basic and diluted loss per share in the third quarter of 2015 was $0.18. This net loss included $3.9 million in non cash share-based compensation expense and a $200,000 non cash loss on the change in fair value of derivatives, as well as a $1.6 million charge for a non cash deemed dividend for accounting purposes. For the nine months ended September 30, 2015, we reported a net loss of $127.2 million or basic and diluted loss per share of $0.71. This net loss included $10.2 million in non cash share-based compensation expense, a $400,000 non cash loss on the change in fair value of derivatives, and $33.9 million charge for non cash deemed dividends for accounting purposes. We reported cash and cash equivalents of $119 million at September 30, 2015 representing a net decrease of $25 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. Net cash outflows from operations for the nine months ended September 30, 2015 were $60.1 million as compared to $58.7 million in the same period in 2014. Cash used for operating activities in the nine months ended September 30, 2015 included approximately $20 million more for supply purchases than the corresponding period of 2014. As we commence 2014 with higher than needed inventory levels for reasons previously discussed. As a result of the timing of certain items, including interest payments, supply purchases, legal costs and REDUCE-IT expenses, we expect continued quarterly variability in cash outflows from operations. That concludes my comments on Amarin’s Q3, financial results. I’d now like to take the opportunity to introduce Kate McNeil [ph] who joined us this week to head up Investor Relations and certain other important areas of communications for Amarin. Kate brings over 15 years of experience in investor relations and public relations including significant experience in the pharmaceutical industry. We are very excited to have Kate joined the team. She’s coming up to speed quickly and we look forward to having her participate in future calls. I’ll now turn the call back to John Thero, for closing remarks. John?

[John Thero:]

Thank you, Mike. During Q3, we made important progress as it relates to each of our organizational priorities included accelerated revenue growth, on track execution of REDUCE-IT and continued management of costs resulting in a cash balance of $119 million as of September 30, 2015. We remain focused on these priorities and look forward to the continued implementation of its standard marketing programs in conjunction with the First Amendment opportunity to educate physicians on additional truthful non-misleading information in regards to the potential benefits of Vascepa. While we have briefly commented on our continued progress in China with Eddingpharm. I should add that we continue to explore other strategic opportunities, the timing and structure which are difficult to predict. We are talking with a number of companies in a number of regions of the world. When terms are agreed with one or more of these companies, we’ll of course let you know. In the interim, our focus is on what we more directly control such as REDUCE-IT progress and the U.S. revenue growth. With that, we conclude our prepared comments and we move to open the line to some questions. Operator?

[Operator:]

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Shaunak Deepak with Jefferies. Please proceed with your question.

[Shaunak Deepak:]

Hi. Thanks for taking my questions. I want to know, I might have missed this in the call, but are you still on track to complete the enrollment of REDUCE-IT by the end of the year? And also, is it possible to give a little bit more granularity on what you might expect to have the interim update in 2016?

[John Thero:]

Shaunak, thanks for the question, this is John. I’ll take that and Steve Ketchum is here, if I miss up he’ll I’m sure correct me. With respect to the enrollment, we’re about 7,800 of the patients enrolled at this point in time on a -- our target for right around 8,000. Based upon our current trajectory, that enrollment should be completed around the end of the year. It varies from week to week, how many patients are enrolled or is it possible that there could be some spill over into early 2016? Yes, but for the most part we see the enrollment wrapping up here in the relatively near-term. With respect to the timing of the interim look for safety and efficacy in 2016 which I know a number of investors are excited about, because they looked at [indiscernible] data and see that fairly early divide in that study with respect to the trial, but I do remind people as Steve has outlined, it is much more common for trials to run them self to their completion and our guidance is that REDUCE-IT is mostly -- most likely to run itself to completion. The timing of that at this juncture is much more dependant upon how well the data comes together. And by that I mean, and this is not -- this is true for all clinical trials, and pulling that data together and throughout this process of pulling the data together its blinded to us, but we -- in the REDUCE-IT study you’re operating in [indiscernible] 450 sites, until you pull all the data together you don’t really know if you have all the data and you put it into the tables and then you look at it and there’s sometimes chasing of data around not to provide -- manipulate the data in anyway but to make sure you have a complete dataset. And there is variability into how long that takes. So at this juncture we’re far enough along with the events to be able to say that and a likelihood the interim look will take place in 2016 whether it has the low-end of the time curve or the longer end of the time curve remains to be seen. So I can’t tell you first half or second half at this point in time because there really is a lot of variability in there and again this is common for clinical studies. Jumping forward to the end of the study assuming it goes that far, we will probably have a better sense of the timing for pulling this data together based upon what we see as the interim look. But we’ve talked about the results, the trial being completed in 2017, results in 2018 unlike the interim look where the 60% of the results is likely to occur early enough for us to be able to bandwidth the most likely sort of high and low ranges of timing for pulling the data together and feel comfortable that that’s going to most likely occur in 2016. At the end of the study based upon our current expectations that last event, 1,612 event is likely to occur in 2017 in a timeframe where it would be fairly quick for us to pull all that together in 2017 which is why we’re saying 2018. So hopefully those comments are useful to you. All of that -- in terms of tightening up guidance relative to the interim look its one of those things where you don’t actually know how long its going to take until folks get in there and do it. For our -- both our ANCHOR and MARINE studies we had estimates from our CRO of how long that process would take, and in both cases it went faster than expected but those are much smaller studies. And as you know all the end points were hit and the safety was terrific, but it was a much, much more study with much less data being collected. And while I would love to think that we’ll have three for three in that regard, we really just don’t know and won't know until the data is collected.

[Shaunak Deepak:]

That was helpful. And the other question I had was really on the ANCHOR indication, and I know that it’s too early at this stage to really comment specifically on prescription growth attributable to that indication. But just wondering if you had any early metrics on how physicians or patients might be taking to the potential for using Vascepa in this broader indication?

[John Thero:]

I think your comment about it being too early is [indiscernible]. At this point in time we’d only have the anecdotes. We have the anecdotes physicians expressing to us that they appreciate the information. We’ve anecdotes of physicians, asking us to come back and talk to them further. We have greater attendance at events where we have physicians speaking to their peers. So we’re seeing interest, but it’s -- we haven’t yet started market research as to message retention or affect, we didn’t start doing the sort of outreach on this until second half of August with our co-promotion folks starting slightly after our own team started and we are as Aaron pointed out taking a very staged approach. We’re taking a piece of information and making sure that docs understand that piece and then we’ll move on to another piece. We are spending a lot of time with physicians to ensure that they understand the information and that we’re presenting it in a factual and balanced approach which takes some time to get it right. I will remind folks that this is not an indication. We think that the information that we are communicating is valuable and powerful and we’re optimistic that is going to have a positive effect in patient treatment as well as on our script levels. But it isn’t quite as direct as marketing a new indication and in particular it doesn’t change anything at the payer level. So you may remember that we have pretty good formulary covered overall, a formulary for over 200 million lives in the U.S. I think the last report was 100 million -- over a 130 million lives on Tier 2 that number has gotten high enough and continues to grow that we haven’t provided quarter-to-quarter updates that I think we’re beyond that at this point in time. Similar to predecessor drugs like Lovaza there has been historically pretty good off label health -- payer coverage of off label use a lot of Lovaza use, that’s been off label less so for Vascepa that may increase here -- its likely to increase here as we move forward. But we need to make sure that physicians are comfortable that their patients will be reimbursed here on off label use and some docs get that right away, some docs need more comfort in it, it does vary from health plan to health plan. So there’s a lot of education going on. We’re encouraged, but it’s early and the short answer is it really is too early to provide any quantification at this stage. We have provided some guidance to what we think that Q4 revenues might look like as Mike had articulated but in the fourth quarter we will -- just gotten to the early stages of communicating essentially our second module of information with the idea of additional information rolling out as we get into 2016 as well. So hopefully those comments are useful.

[Operator:]

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

[John Boris:]

Thanks for taking the questions. But first since you are in continued -- still under discussions with the agency which runs through December 17, maybe for Joe Kennedy. Can you maybe just shape the framework of what the key issues and their arguments are? I’m not looking for what your negotiated position is, but what are the key points that you’re negotiating with the FDA or are you asking them to reinstate the SPA for example something to that degree. Second for Aaron, on the promotion of the product, it seems like you’ve taken a very conservative posture with the sales force in terms of your promotion. When do you incorporate not only ANCHOR but also [indiscernible] into the discussion which I think judge Engelmayer allowed you to be able to use both of those points within discussions with physicians. So those are my two questions. Thanks.

[John Thero:]

So I will have Joe comment on both of those. Let’s start with the first amendment piece and then we’ll turn things over to Aaron to talk about the promotional piece. Joe?

[Joseph Kennedy:]

Right. Thank you, John. So the framework for our approach to -- our goal is going into tell in the negotiations were essentially to take the win that we achieved at some of the declaration point and make that final. That’s our primary goal. That ruling was both broad and specific broad in the sense that it allowed us to seek in a truthful non-misleading way which affected the promotion of Vascepa in the ANCHOR patient population, and specific because it declares the ANCHOR data which -- to which there is no contest from in FDA to be truthful and non-misleading in the context of the statements that were part of the litigation ultimately announced on August 7. So our goal is to take that preliminary ruling and to make it final so we can continue along the path of promotion of Vascepa to the ANCHOR -- for using the ANCHOR patient population. And now with respect to the broader aspect of the ruling, you’re right, with regards to the [indiscernible] promotion that broad aspect to the ruling review has enabling us to speak in a truthful non-misleading way to promote Vascepa in a truthful non-misleading way with respect to data that goes beyond the ANCHOR data, so long as that information is truthful and non-misleading. And so with regard to your specific question as to whether we’re looking to re-implement the FDA or to get a label expansion the short answer to that is no. The FDA has taken a lot of regulatory steps to create a leveled playing field in that regard by taking away indications from pirate product. By taking away indications from [indiscernible] product with regard to an add on to statin which in effect gives us a leg up in our ability to now speak to the use of Vascepa on top of statin’s. So I think that answers your question, if not I’m happy to take a follow-up.

[John Boris:]

Thanks.

[John Thero:]

And as part of that, I mean we do talk about this as being a court order of declaration, just for emphasis there was a lot of input from FDA in the process of getting to what is appropriate disclosure of the ANCHOR data? What are appropriate disclosures along with that? Including the FDA asking that we emphasize failed studies of fibrates and niacin, which allows emphasis for and the fact that those drugs are not no long approved on top of statin therapy. And of course FDA is much encouraging us to complete the REDUCE-IT study as the first study in this phase and lots of reasons to be optimistic about the REDUCE-IT study. With that, let me turn things over to Aaron to expand upon our comments about state and thoughtful [ph] launch of the various modules of information under the first amendment.

[Aaron Berg:]

Thanks, John. And thank you John for the question. So as John just mentioned we continue to take a very staged thoughtful approach to rolling out first amendment. We started with ANCHOR, its just two months in. Sales force is very enthusiastic, but as you know its takes time to get the physicians, once not to mention the multiple times it takes to get them to remember a message to change behavior to impact patient care, to get those patients in that are again a chronic disease and it takes time. With that said, we’re very much looking forward to getting [indiscernible] out there later on here in Q4 we’re prepared to roll that out. In the coming weeks we’ll do that in a very balanced truthful non-misleading way as we’ll continue to do. There’s a lot of good information in [indiscernible] that we’re looking forward to getting that out.

[Operator:]

Thank you. Mr. Thero, there are no further questions at this time. I’d like to turn the floor back to you for any final concluding remark.

[John Thero:]

Thank you everybody for joining us today. I know you need to get back to other things, getting ready for the market to open. We look forward to providing you continued updates on the ongoing progress of Amarin in multiple areas. Thanks again. Bye.

[Operator:]

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