Q2 2017 Earnings Call Transcript

Published: 2 Aug 2017

[Operator:]

Welcome to Amarin Corporation’s Conference Call to discuss the Second Quarter 2017 Financial and Operating Results. This conference is being recorded today, August 2, 2017. I would now like to turn the conference over to Elisabeth Schwartz, Senior Director Investor Relations for Amarin.

[Elisabeth Schwartz:]

Thank you all for joining us today. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of Vascepa prescriptions, Vascepa product and licensing revenues, trends and wholesaler inventories, cost and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources, our current expectations regarding our cardiovascular outcome study, such as timing of interim analysis, study completion, regulatory review and likelihood of success, our plans and preparation for expanded promotion of Vascepa and related market positioning potential. Our plan to purchase additional supply of Vascepa, our goals regarding the timing and scope of international expansion and our current expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, August 2, 2017. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially. So you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that we may enter into, amend, or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statement section in today's press release and the risk factors section of our Quarterly Report on Form 10-Q for quarter ended June 30th, 2017. These documents had be filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of Vascepa outside its approved indication. Please note that we are also providing slides to accompany this morning’s call. These slides, which can be found on our website www.amarincorp.com in the Investor Relations section under the sub category of Events and Presentation, summarize some of key updates discussed on today’s call. Finally, an archive of this call will be posted on the Amarin website also in the Investor Relations section. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

[John Thero:]

Good morning. As referenced in our press release, it’s an exciting time in Amarin with record reported revenues in the completion of our landmark, cardiovascular outcome studies getting closer. We appreciate that you are joining us for this call. We recognized that many companies were reporting this morning. We will try to keep this call succinct. As in the past, we will start with prepared remarks regarding Amarin’s recent commercial, operational and financial performance and then open the line to questions. Q2 historically has been a good quarter for Vascepa growth and Q2 2017 was not an exception. We achieved record net product revenues of $44.9 million in Q2 2017 bringing net product revenue for the first half of 2017 to $79.3 million. Unlike in Q2, 2016 revenue growth in Q2 2017 does not appear to have been significantly impacted by changes in Vascepa inventory levels at independent wholesalers. Such inventory levels which we don’t control began and ended Q2 2017 with little change and within a typical industry range based upon day-to-day sales. Vascepa product revenues in Q1 and Q2 2017 exceeded our expectations coming into 2017. We are bullish that we will continue to see meaningful revenue growth for the balance of 2017. Our net product revenue growth has been led by continued productivity improvements by our commercial team in the positive effect of expanded managed care coverage implemented at the start of this year. Accordingly, we are increasing our guidance for full year 2017 Vascepa net product revenues to an estimated range of $165 million to $175 million. Mike Kalb our CFO will provide additional comments regarding our financial performance. I first want to make a few comments regarding our landmark cardiovascular outcome study REDUCE-IT. Recall that this 8,175 patient study started in late 2011. It is a pleasure to have reached proximity to the completion of the study that currently we were able to talk about likely having results from this study approximately year from now. When we started the REDUCE-IT study, industry focus was on lowering LDL known on bad cholesterol and raising HDL known as good cholesterol. Since that time, the increase has increasingly recognized that lower LDL cholesterol is important to lowering cardiovascular risk. But that even with lowering LDL cholesterol many patients still have significant residual risk. During this time period, clinical results have led many to question the benefit that can be achieved by raising HDL or good cholesterol. Clinically, the approach of focusing on raising good cholesterol is being marginalized. Importantly, the need to lower cardiovascular risk after statin therapy has also led many to revisit how improving other biomarkers of cardiovascular risk may help to address the very significant residual cardiovascular risk remaining after statin therapy including lowering persistence, high triglycerides, ApoC-III and other measures of acrogenic particles as well as showing benefit in inflammatory markets in reducing coronary plaque. Vascepa 's current clinical results from the MARINE and ANCHOR studies as well as other supportive data on these parameters have led opinion leaders to consider how Vascepa fits us need and has brought increased attention too and interest in the ongoing REDUCE-IT study. Some of these trends and thought have not yet extended to most general physician practices, but key opinion leaders now are increasingly turning to consider Vascepa. This trend is enhanced in the context of recent cardiovascular outcome studies like CANTOS where the focus was on an inflammation marker and against the backdrop of a large generic studies presented since the start of REDUCE-IT, which just as triglycerides and LDL cholesterol levels are similarly affective as predictors of coronary heart disease. The attention is further supported by evidence of EPA's various potential cardiovascular protective mechanisms beyond triglycerides lowering and of course, the successful JELIS cardiovascular outcomes of EPA in Japan. This evolution of thought is gaining momentum. There is growing recognition that understanding the significance of lipids, lipoproteins and inflammatory markers on cardiovascular disease is a complex undertaking. It is often not just improving a particular biomarker that may matter, but rather what drug affects maybe at play when improvements are consistently shown among relevant biomarkers. That is a main matter of how the markers are improved with what drug and what are the biomarker improvement signaling about potential cardiovascular risk reduction That is the perspective though leaders have applied to Vascepa, which has consistently showing improvements in the classically studied lipids, lipoproteins and inflammatory markers and as other supportive evidence of cardiovascular risk reduction. An obvious example comes from results of the JELIS study in which the effects of EPA were evaluated, but as we have outlined previously the support of evidence which gives us confidence in REDUCE-IT goes well beyond JELIS study. Furthermore, there is great conversion on the needs to manage associated risks of not only cardiovascular disease but also diabetes and obesity which is drawing increased attention of cardiologists, lipodologists, endocrinologists and other thought leaders. In July, a group of physicians independent of Amarin formed and attended a medical conference where the intersection of treating these very disease conditions was the central focus of attention. I believe that the results of the REDUCE-IT study, assuming the results are consistent with our expectations will help accelerate this dialogue and provide physicians with improved pathway for addressing this pressing medical challenge. The incidence of cardiovascular death in the U.S. is increasing and the cost of care is huge. Demonstrating that Vascepa can reduce the occurrence of major cardiovascular events should be a significant advance for preventive medical care and lower the cost of treating such events. In the past couple of years, including recently, we have seen reports of other therapies that have been advanced a potential add-on therapies to statin treatment. These therapies highlight the importance of residual risk to be addressed beyond LDL Cholesterol lowering with statin therapy. Thus far, none of these studies have reported the level of relative risk reduction as reported in JELIS study. The study in Japan of the outcomes benefit driver from adding EPA to statin therapy. And while none of these other studies have evaluated the effects of therapies in the patient population being studied in REDUCE-IT. It is notable that Vascepa is unique from the therapies being studied by others not only in its mechanisms of action, but also with regard to such practical factors as product affordability, route of administration meaning oral versus injectible, safety profile and tolerability. We are seeing an interest in greater importance being placed on pragmatic treatment. Pragmatic treatment has five key elements. Efficacy, safety, ease-of-use including tolerability, low cost and fit for the treatment paradigm. Vascepa already has existing clinical data in years of [indiscernible] approval market experience that support its favorable efficacy, safety and tolerability profile. It also has a convenient oral dose form and affordable price and broad managed care coverage. These attributes have positioned Vascepa favorably in its current market. We believe the fact that Vascepa is today a currently available and pragmatic treatment will help Vascepa potentially become a standard-of-care therapy following positive REDUCE-IT results. Collectively these recent studies by other companies provide us with added confidence in the potential opportunities for Vascepa. Individually, results suggested by top-line reporting of the CANTOS study provides us with added encouragement regarding the potential for positive results in the REDUCE-IT study. The CANTOS study suggested that there is value to lowering inflammatory markers and statin treated patients and emphasize the high level of cardiovascular risk in secondary prevention patients. Effects of Vascepa in Phase III studies included the Vascepa lowered variant inflammatory markers and secondary prevention will represent an important subgroup of patients in the REDUCE-IT study as it is one of the inclusion criteria for assessing risk for enrollment into the study. A complete list of inclusion criteria for the REDUCE-IT study is available on our website at www.amarincorp.com. Amarin of course remains blinded to the results of the REDUCE-IT study. As expressed previously, we expect that the onset of the target 1612 primary [mase] (Ph) events in the study, which is the target for study completion will be reached in early 2018 with the results of the study reported in Q2 or Q3, 2018. We do not have an update to provide you today regarding the scheduled interim efficacy and safety review by the Independent Data Monitoring Committee based upon approximately 80% of the target events in the study. Except to say that we are informed that we should expect to get a report from the committee this quarter and after which we will provide a public update regarding the committee's recommendation. We emphasize that Amarin will not see the data as part of this review and moreover, for the reasons that we have previously described, we do not anticipate that the independent committee will recommend shortening the duration of this first ever study in this important patient population. We have been conducting the study for over five years, we too want a robust results, which we believe to be in the best interest of patient care, Vascepa's commercial opportunity and of course, our shareholders. At this point, I would like to turn the call over to Mike Kalb, our Senior Vice President and Chief Financial Officer. Mike.

[Michael Kalb:]

Thanks, John. As John mentioned earlier in the call, second quarter of 2017 showed significant product revenue and strip growth over the corresponding quarter in 2016. Our Q2 net product revenue of $44.9 million was $12.1 million or 37% above the $32.8 million reported for the three months ended June 30, 2016. We recorded net product revenue of $79.3 million and $58.3 million during the six months ended June 30, 2017 and 2016 respectively an increase of $21.2 million or 36%. Our rise in Q2 net product revenue was driven primarily by increase in normalized total Vascepa prescriptions led by continued productivity improvements by our commercial team and the effect of expanded managed care coverage implemented at the start of 2017. These positive factors were partially offset by a slightly lower average net selling price for Vascepa during the quarter driven primarily by a higher proportion of revenues derived from Vascepa prescriptions filled by patients covered by Medicare insurance. The rebate levels for which are higher on average in the rebates offered under the commercial managed care insurance plans. Based on data provided by Symphony Health Solutions and IMS Health, estimated normalized total Vascepa prescriptions during Q2, 2017 increased by approximately 114,000 and 127,000 respectively to 344,000 and 372,000 respectively over the three months ended June 30, 2016. This calculates to associated growth of approximately 50% and 52% respectively over Q2, 2016 and 13% and 11% respectively over the first quarter of this year. As reported previously, during Q2, 2016, an increase in the level of inventories held by our distributors calculated based on estimated days of Vascepa sales on hand resulted in the net overall increase in net product revenues of approximately $2.9 million to $3.2 million. During Q2, 2017, the level of inventories held by our distributors increased modestly as compared to inventories held at the beginning of the quarter as calculated on the same basis. Accordingly on a pro forma basis, without the impact of the changes in channel inventory levels, our percentage of net product revenue growth in Q2 2017 was consistent with the Q2 2017 growth in prescriptions. As we have commented previously, prescription levels do not absolutely correlate to product revenue as channel inventory levels on a day sales basis vary based on a number of factors. We also believe based on information available to us, the channel inventory levels at the end of the second quarter 2017 are with an ordinary ranges. As John mentioned, we are increasing our guidance for 2017 Vascepa net product revenues to an estimated range of $165 million to $175 million from the $155 million to $165 million guidance range we provided earlier this year. In addition to product revenue, we recognized licensing revenue of $300,000 in Q2 2017 and $600,000 in the first half of 2017. Such licensing revenue relate to agreements for commercialization of Vascepa outside the United States. Most of this licensing revenue came from the amortization of the initial $15 million we received from our agreement with [indiscernible] China. Gross margin from product revenues was 75% in the second quarter of 2017 as compared to 73% for the second quarter of 2016. this improvement was driven primarily by lower cost, especially reduced API production costs. Selling general and administrative expenses for the six months ended June 30th, 2017 and 2016 were $65.7 million and $54.1 million respectively, an increase of $11.6 million or 22%. The increase is due primarily the increased co-promotion fees resulting from increased sales levels, increased promotional activities and increase legal cost which are subject to quarterly variability. Research and development expenses for the six months ended June 30th, 2017 and 2016 was $24.5 million and $26.3 million respectively, a decrease of $1.8 million or 7%. This decrease is mainly due to timing of REDUCE-IT and related costs. Amarin reported cash and cash equivalents of $85.5 million at June 30th, 2017. Net cash flows from operations excluding the Q1 debt restructuring, interest in royalties and the R&D costs in the three months and six months ended June 30th, 2017 were modestly positive. We are anticipating that net cash flows for 2017 as a whole on this basis will be positive. However we expect continued variability to the timing of certain items including API purchases and payments to our Vascepa co-promotion partner. In particular, we expect our cash outflows to be somewhat higher due to the timing of payments in Q3, 2017 and Q2, 2017. While we are approaching the end of the REDUCE-IT study, we have not yet reached a phase where cost declined meaningfully and savings will realize from no-longer recruiting patients for this study offset cost associated with preparing the study for completion including conducting the upcoming interim look. For the six months ended June 30, 2017 cash outflows related to research and development were approximately $20.8 million and cash paid for interest and royalties in aggregate was approximately $7.5 million. We anticipate that our SG&A expenses excluding non-cash costs in the second half of 2017 will approximate expense levels in the first half of the year. We expect R&D expenses excluding non-cash costs in the second half of 2017 will remain in a range which is consistent with R&D expense levels in the first half of 2017. The majority of these costs are REDUCE-IT related. We expect that our operating expenses levels to continue to vary from quarter-to-quarter. Internationally, our partners in China and the Middle East are making progress. Our partners incurred the vast majority of costs related to developing these markets for Vascepa. We anticipate clinical study of Vascepa in China to be commenced by our partner later this year. We anticipate that late in 2017, or early in 2018, we will receive word from our partner in the Middle East that they have secured the first of what we hope is a series of approvals from countries in the Middle East allowing for promotion of Vascepa in those countries by our partner. As of June 30, 2017 we had $37.5 million in net accounts receivables which are current, and $24.8 million in inventory. As of quarter end, we had accounts payable and accrued expenses of $65.6 million which increased from $43.8 million at December 31, 2016, primarily due to the timing of rebates, co-promotion fees and supplier payments. For those who are modeling our financials, beyond 2017 we want to highlight that under the Kowa agreement, there are differences between expenses and cash flow as they related to pending tail payments. Assuming Kowa continues to effectively co-promote Vascepa for at least the balance of 2017 and 2018 as planned, Kowa is entitled to a tail payment based off a levels co-promotion fee they earn in 2018. We anticipate recording such tail payments as part of SG&A expense under U.S. GAAP in 2018 despite the payment becoming due from a care perspective and installments over three years beginning in 2019. This anticipate a 2018 accrual of non-cash expense of the tail payments is not part of our 2017 expense levels. This tail payment provisions is not new, we draw more attention to it now because we are getting closer to 2018 and we wanted to highlight this upcoming difference between expense accrual and later cash payment under the agreement. What is new, is that we recently amended the Kowa agreement. The amendment was made to tighten physician targeting by Kowa sales representatives without lowering the overall number of sales calls made by Kowa sales representatives. We do not expect cash outflows to Kowa under the amended agreement to exceed percentages and the teams of gross margin in 2017 or 2018 as the amended co-promotion fee is 18% in 2017 with a modest increase in 2018 partially offset by certain other refunds. As a reminder, our relationship with Kowa is expected to conclude at the end of 2018 after the anticipate reduce good results. As of June 30, 2017, Amarin had approximately 270.8 million American Depository Shares or ADSs and ordinary shares outstanding. 32.8 million share equivalents of Series A convertible preferred shares outstanding and approximately 23.7 million equivalent shares underlying stock options at a weighted average exercise price of $3.25 as well as well as 12.1 million equivalent shares underline restricted or deferred stock units. I will now turn the call back over to John Thero for closing remarks.

[John Thero:]

Thank you Mike. We look forward to continuing to provide you with updates regarding Amarin’s progress. We are scheduled to attend three investor conferences in September including Citi’s Annual Biotech Conference, Rodman & Renshaw’s Global Investment Conference and Canter Fitzgerald’s Healthcare Conference. We will webcast any podium presentation we make at these conferences. As promised, we will provide an update on the recommendations of the DMC based upon their interim look at REDUDE-IT efficacy and safety results. In speaking with investors, it sounds like we appreciate that it’s unlikely that the recommendation of the DMC will differ from the recommendation of continuing to completion. Hopefully Amarin has made it clear that our expectation is that the study will continue to completion. Just as continue to completion recommendation was not a major news issue at the 60% interim look last year, the same will hopefully be a results of the recommendation from the 80% look. Although a key difference is that the study is now a year closer to completion in that in the expected, continue to completion scenario we anticipate it having results from the study to report approximately a year from now. With that, we conclude our prepared remarks, we would like to open the lines for questions. Operator.

[Operator:]

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions]. Our first question is from Louis Chen with Canter Fitzgerald. Please state your question.

[Louis Chen:]

Thank you for taking my questions here and congratulations on the strong quarter. So I had a few questions here, first question I had is in terms of the REDUCE-IT study, when you report the final results in 2018 what type of outcome do you think that you need to see to drive further uptake of the product. And then second question I have is if the REDUCE-IT study is positive, would you increase your marketing to consumers and what type of programs would you pursue and how should we think about the cost for that? And then the last thing is if REDUCE-IT is positive, do you think that you will continue to market this drug on your own or would you seek a primarily care partner, how do you think about the expanded market opportunity ? Thanks.

[John Thero:]

Louis this is John, thanks for the questions. I’m here with the variety of teammates, but let me dive into those responses and I think I can cover but they will jump in if I’m missing anything major. You know with respect to your first question, results of the study and what is meaningful and that’s actually a very interesting question. We had done some market analysis several years ago that suggested that you know anything in the high single-digits rather in terms of relative risk reduction would be meaningful particularly given a product that has the affordable cost and safety profile of Vascepa. Since that time, other studies have reported out that have had in some cases like in improving some repetitive despite even lower risk reductions in that. Other studies have reported out like on PCSK9 that I think also somewhat lower the bar of not outstanding relative risk reduction and that relative risk reduction at a very high clock. So from a commercial perspective, I think in some percent of the bar is lower than what there maybe from a regulatory perspective. From regulatory perspective of course, we need to hit opportunistically significant relative risk reduction. we are in parallel and continuing to look at real world economic data all of which is continuing to support our thesis here that addressing lipid proteins and other markers of risk beyond LDL reduction provides value in that in patients who have high triglycerides that the risk is significantly higher than those without. So this will all become much clear obviously we have REDUCE-IT results, but I think that the need for what described in the calls pragmatic treatment that it's just five characteristics we think - which [indiscernible] Vascepa touches on across the board will position Vascepa uniquely and positively. With regards to the marketing of the product post REDUCE-IT, there are a lot of planning on that. We have intentionally kept this current size of our sales force steady. And we have evaluated and continue to evaluate whether certainly we are [indiscernible] in our analysis show that we would add more sales reps today, we will grow revenues faster. We have harboring our cash to as we said in our 10-Q our current resources on a cash side get us through the REDUCE-IT results. We think that the right spending of our cash is to continuing to invest that in the completion of the REDUCE-IT study. Coming out of the REDUCE-IT we think that the right size for our U.S. based sales team is between 400 and 500 sales representatives. That would be not necessarily initially, but hopefully shortly thereafter. We also are begin to evolve into consumer marketing, we have historically been predominantly directed-to-physician in our promotion of this product. But given the nature of the product and the number of people effected and with outcomes results, we think we should become a consumer story. We have recently added a experienced consumer in marketing person and we are doing analysis to as to what the right messaging would be, what the right timing would be and we actually begun some further market analysis, we will have better answers internally at least really need to see REDUCE-IT results before pulling the trigger on it, as to what scope of consumer and marketing should be executed on. But expanded sales force in that range would also have consumer feeds that details will be better illuminated after we see the REDUCE-IT results. In terms of the last question about do this on our own, we continue to go forward with our existing [indiscernible] partner or do we do something with somebody else. The piece that we can control here is our own execution, so you know we think that this is an opportunity that should be measured in the vision in terms of dollars, we have progressed to this point and have terrific support amongst KOL, terrific managed care coverage, good strong supply, we have got five years now of positive history in the market. We think we are positioned at you know - we can do this ourselves, but we work for our shareholders so we are always looking for how can you maximize value but we are not relying on others, we can’t control that piece, we are making sure that we can do it on our own and we think we can. I hope that answered your questions.

[Louis Chen:]

Yes, thank you very much.

[Operator:]

Our next question is from Joel Beatty with Citi. Please state your question.

[Sean Lavin:]

Good morning, this is Sean calling in for Joel. Thank you for taking my questions. So with REDUCE-IT outcomes getting close, can you talk to us a little bit about key secondary endpoints and individual maybe sub components that you think could be meaningful for your message in marketing strategy? And could you frame that answer and the CapEx of CANTOS and how that read-out may have changed the way that you are approaching this?

[John Thero:]

Good morning Sean. I will jump in a bit on the first piece of it, and then I will ask our Chief Medical Officer Craig Granowitz to talk a little bit about CANTOS. With regard to secondary endpoints, for our ANCHOR study in our MARINE study, as you have probably seen we have a strong series of publications over extended period of time. The science in lipid management is deep and evolving, pretty complex actually. And the signs behind [maintenance fee] (Ph) is equally deep and complex. We think that there has been value because different key opinion leaders look at different lipid measures in different ways to having broad data for people who want to dig deeper. That being said, what really matters here is the primary endpoint of this study and on the primary endpoint we think we are off to the races relative to the commercial marketing as its really getting to that primary endpoint that is key. While we look at the underlying data, from the start, absolutely, because we want to make sure that we are not conveying information which is in anyway misleading, but what matters most is the primary endpoint, ROE across the [indiscernible] endpoint reduced in residual risk in a significant way versus placebo and statin therapy and I think that’s really where the primary focus should be. Relative to CANTOS, Craig if you want to jump in on that.

[Craig Granowitz:]

Sure Sean thank you for your question and we are very excited by the results of CANTOS and that they are going to be presented at the European Society of Cardiology meeting later this month. We believe that it’s an important study for a number of reasons. The first and most importantly it highlights again the residual reaction and need for treatment beyond just lowering in the LDL. And that significant risk remains despite managing patients with statin. And in that regard it continues to highlight that the number of steps to the cardiovascular disease in the United States actually is reverse that negative trend is actually increasing again and remains the number one cause of death in the United States. The second issue around CANTOS study is it validate that there are new mechanism of actions that are out there and that new mechanisms of action can have a clinical effect on top of all the existing treatments that are available. Specifically to Vascepa, many of the same markers that are important in the CANTOS trial are also positively affected by Vascepa particularly CRP. And as you know CRP is a entry criteria for the CANTOS study and we have demonstrated a number of our trials and published that CRP levels are affected by the Vascepa. So we believe one of the mechanisms of action of one of the many mechanisms of actions of Vascepa is related to the its anti-inflammatory effect. The nature of which are exactly has not yet been characterized, but certainly it's another positive indication on the connection of inflammation and outcomes and we know that Vascepa is an important anti-inflammatory. I think the last area of that is important and John touched on it in his comments is the importance of having a pragmatic therapy. And I think there has been quite a bit written about the cost and administration of [Alaris] (Ph) which is the drug study did in CANTOS in a very high per dose cost and in injectable route of administration, I think will make that product far more difficult to be use across the tens of millions of people that are at risk. And in that regard, we also see the [indiscernible] validation of Vascepa, our lower acquisition costs, our great tolerability profile and over 150,000 patients on treatment today and the ease with providing a oral dosage form into the current modes of care today. So I think in that regard we see CANTOS is close to [indiscernible] in and off its own right, but further validating the Vascepa in REDUCE-IT hypothesis.

[Sean Lavin:]

Great. Thank you for that answer. And as a quick follow-up, are there any co-indications currently in the patients in the 500 plus indication that clinicians are using Vascepa more in and do you think those trends could forecast that how the market could play out after REDUCE-IT?

[John Thero:]

The broad spectrum of benefit provided by Vascepa has been published and is available to those clinicians who are paying attention. as a reminder, we are only calling on with our sales force very small sliver of the population of physicians who prescribe lipid modifying therapies. We don't have the resources to go beyond that. And of those knowledgeable physicians, there is a range as to what those physicians view to be the benefits coming from Vascepa and some of them are on the triglycerides side of things, some are on more some specific [indiscernible] majors like APO CIII, or APO B all these are on the reduction in inflammation there is some use that's non-cardiovascular that's going on. But predominantly particularly in the population of patients with very high triglycerides, the risk there is pancreas pancreatitis in particular and whether the physicians key focus is on information reduction or they [indiscernible] reduction or the inflammation reduction they are all pointing towards the view that there is risk reduction coming from the product. I think our opportunity continues to be significant relative to treatment of patients who have triglycerides in 500 in some ways they are not as recognizable in the system sometimes s patients with triglyceride between 150 and 500 many of whom are already on statin therapy for example as we get down below the 500, diversity of use and the value as to what different clinicians particularly are looking, all of the cardiologists, GPs and Endos look at can vary and the broad spectrum of benefits that Vascepa provides is interesting in that respect. Everybody is looking for outcomes data. So moving from biomarkers to outcomes based results we believe will be dramatic and probably provide a very different answer to this question of what we have today.

[Sean Lavin:]

Great. Thank you so much.

[Operator:]

Our next question is from Matthew Andrews with Jefferies. Please state your question.

[Matthew Andrews:]

Hey, good morning, Mike a couple for you. Gross net appears to be variable quarter-to-quarter and looks to be roughly 50 to 55% in Q2. So is that reasonable moving forward through the back half of 2017. Second, can you discuss the expectations on cash levels in the runway and I had a couple clinical after that?

[Michael Kalb:]

Yes, as we mentioned on the call the rebates are greater on the med part-D and I think given where we are with the assets collaged probably a good indication of where we will be in the segment for the year. Expectations on cash, as we have said and continue to say we believe we have enough cash to get through REDUCE-IT results, which complete will be Q2, Q3 and 2018. As mentioned we are cash flow positive when you back out the R&D, Q1 debt restructuring and then interest royalties and various financing instructions and I think that trend will continue.

[Matthew Andrews:]

Okay. Thank you. And then at what point do you consider resuming clinical development of the statin combo AMR-102? And then do you have any sense how broadly Vascepa is being used in the mix with [lipid] (Ph) market and switches from generic Vascepa. And that’s it, thank you.

[Craig Granowitz:]

I think in this question you mean generic [indiscernible] at the end here.

[Matthew Andrews:]

Oh, yes sorry I apologize, you are right [indiscernible].

[Craig Granowitz:]

The generic Vascepa and will not expand the generic growth, Vascepa for a while.

[Matthew Andrews:]

Yes, apologies there. my mistake.

[Craig Granowitz:]

In terms of the combo therapy for those maybe haven’t focused on and thought about that opportunity for a while, we had before the FDA reverse its position upon results from other therapies relative to approval of the [indiscernible] indication coming out of our successful and FDA agreed successful results of the ANCHOR study. We had done feasibility work with regard to combo products. Looking at the combination of Vascepa with Statin therapy actually RESUME statin which is we - as a model for that why, because technically actually that was more difficult statin to work with relative to combinations out flow could prove feasibility with that particular statin if you wanted to do something like [indiscernible] statin that would be technically easier. We reached the stage of proving technical feasibility and then after the FDA’s surprise now four years ago, we have put that product project on hold. it continues to be on hold after we see the REDUCE-IT results, we anticipate that we will have R&D expenditures coming down dramatically versus where they are today. And we will be reviewing a host of different potential development and the opportunities including the potential advancement of the combination product with statin therapy. We wanted to of course, do market analysis at that point in time as to the convenient advantage of having sort of key therapies delivered to - but where we are going to hold off on that position to after we see the REDUCE-IT results. In terms of second question, sorry who is using Vascepa today? And are they above or below 500 specifically in terms of their triglycerides levels? And are we getting those new starts versus switches from the thing that vibrates or from [indiscernible] we have got the right interpretation question. So a few things, one remembering that until about two years ago, we were the only marketing to or only promoting to use of about 500. Following the agreement that we reached with the FDA about a year and half ago, we have been promoting - has allowed the results of the ANCHOR study. Lipids in parallel, the FDA had removed data from label of - as well its effect on patients in the 200 to 500 range is the label of the same guards and also the questioner language and removed from the labels of [indiscernible] matter of use of those therapies. On top of statin that’s in their view of those risk out way they demanded based upon those available clinical evidence. I think in general trying to put everybody on the same footing with respect to labeling for what is known. Is there a difficult to quantify patients who are at various lipid levels and where they start from. We are trying to figure out where the baseline lipids are is tricky in part because yes these patients are often on a prior therapy whether it be [indiscernible] which is predominantly generic these days or vibrates which is predominantly generic these days. And switches occur, we have better anecdotes that got published with the anecdotes of seven patients, 10 patients, 12 patients published over the years by various clinicians showing that patients switch from these other therapies to Vascepa predominantly showed improvement to their lipid profile. But these are not broad, well controlled highs in number strategy, we do remind people that labels for these earlier generation products were all arrived at based upon legislation studies done in the free statin - meaning I would say were studied without any stains in the study. We think that the more real world study of Vascepa has been appropriate and valuable and the fact that Vascepa has been shown to work well both on and off of statin therapy. We think this is a benefit of the safety profile of our growth and benefit as well. Most of our starts, most of our interacts and new starts some of those are patients that probably were on [indiscernible] six months or eight months to go, it’s not uncommon to roll off of prior products. But most of our patient starts are new starts, we are increasingly getting switches, but it’s still predominantly that we are getting patients who are new start then it tends to be the riskier patients and physician practices that you are getting Vascepa as the treatment. So I don’t have specific quantification for you, but I’m hoping that some of those comments are useful.

[Matthew Andrews:]

Yes, they are. Thank you.

[Operator:]

We will take one more call and that would be John Borris with SunTrust. Please state your question.

[John Borris:]

Thanks for taking the questions and congratulations on the result. First question for Mike, just the number of selling days in the quarter versus 2Q of 2016 and then the number of selling days you will have in 3Q versus the year-over-year comparable Mike, that’s the first question.

[Michael Kalb:]

Yes, thanks John. So first I will say that we think we were and continue to be within our normal industry raises based on our calculation we are probably in around the two week range now at the end of Q2 2016 were probably in or around three to four weeks based on days sales on hand. I think the second part of that question where do we think that will go, for the rest of the year, we don’t control obviously all the wholesalers, but if we head around two weeks right now I don’t think it’s a whole lot room to go down.

[John Borris:]

Thanks for that. Secondly on the Kowa agreement, how the agreement actually change, are they are just focusing with the same level of detail effort on more high docile positions, but how would you qualify the changes that were made to that agreement. And then I have one last question that’s clinically driven.

[Unidentified Company Representative:]

Hey John good morning, this is [indiscernible]. With regard to the Kowa, we have been working with them now for three years, they have been contributing positively, we and they have accumulated a lot of experience together. And as looked at targeting and we sought this out that tightening of targeting would be valuable. So they are going to continue to make the same number of sales calls, but we think that rather than calling on a large number of physicians that only get into some of them once per year that tightening it up and going up higher value of physicians makes the most sense. There were some economic changes made to reflect realities of where we are today and relative to basics of that, the key change in terms of driving revenues we believe will be the heightened focus on key targets. And that should drive increased frequencies to those targets and we hope increased subscriptions based upon that targeting.

[John Borris:]

So they are concentrating on more high docile, higher prescribing physicians with the same level of detailed effort.

[Unidentified Company Representative:]

That's correct.

[John Borris:]

Great. And then last question for Steve, one think that Merck clearly indicated was that one of the findings out of the IMPROVE-IT study was the that the longer that it went the data clearly at the tail end of the curve matured and separated clearly from the active statin arm. They used that finding to allow REVEAL to go completion, but again it was at the tail end. Although the results haven't been presented, but it was more at the tail end where there was separation that led to a statistically significant effect. Just your thoughts about the read through from those two studies and most notably REVEAL which is just recently outlined to that of the IMPROVE-IT study?

[Steve Ketchum:]

Yes well I think once not only you are speaking to is ensuring that you have sufficient patient follow up. And as you know from our study design, it was designed to have a median follow-up of about four to five years and as published in our design paper that will be some patients follow for as long as 6.5 years. So and then of course, each molecule is going to have its own potential timeframe across which it might separate from the placebo arm. And of course we are have the JELIS results, which at least in that study the exact same active ingredient separated early and continue to maintain its separation. So these things can vary depending on the mechanism of action obviously for the REVEAL study. You are talking about [indiscernible] inhibition, and in the IMPROVE-IT study you are talking about different class of agent being added on to a statin therapy [indiscernible]. So we feel confident in our study design in terms of our follow-up and in terms of the other design parameters. And I hope that addresses your question.

[John Borris:]

Thanks, Steve. It does.

[Operator:]

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