Amarin Corporation PLC (NASDAQ:AMRN)
Q4 2016 Earnings Conference Call
February 28, 2017, 07:30 AM ET
Elisabeth Schwartz - Investor Relations and Corporate Communications
John Thero - President and Chief Executive Officer
Michael Kalb - Chief Financial Officer
Craig Granowitz - Chief Medical Officer
Todd Grisco - Vice President Managed Care
Aaron Berg - Senior Vice President of Marketing and Sales
Steven Ketchum - Senior Vice President of R&D and Chief Scientific Officer
Joseph Kennedy - Executive Vice President of General Counsel and Strategic Initiatives
Joel Beatty - Citigroup
Chiara Russo - Cantor Fitzgerald
Hugo Ong - Jefferies
Welcome to Amarin Corporation’s Conference Call to discuss its financial and operating results for the fourth quarter and full-year of 2016. This conference call is being recorded today February 28, 2017.
I would now like to turn the conference over to Elisabeth Schwartz of Amarin.
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 prescriptions and wholesaler inventories, perceivable product and licensing revenues, costs and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources, our current expectations regarding our cardiovascular outcome study, such as the 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 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, February 28, 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 other 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 Annual Report on Form 10-Q for the year ended December 31, 2016. These documents will be filed with the SEC and will be 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 again in the Investor Relations section.
I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.
Good morning everyone thanks for joining us today, 2016 was a year of substantial achievement for Amarin commercially, operationally and financially. Two obvious highlights for 2016, while record product revenues of $129 million and are moving to within approximately a year of the onset of the final target event in REDUCE-IT our landmark cardiovascular outcome study.
As stated in our press release issued this morning, Vascepa product revenues in 2016 grew 59% over the prior year. Other notable achievement by Amarin in 2016 include improved gross margin on product sales to 73% in 2016 compared to 66% in 2015.
Strengthening our balance sheet through transactions in 2016 and early 2017, which lessened Amarin's burden of exchangeable debt from a face value of 165 million to 30 million with the first foot date update on the remaining debt five years away. Improved our cash flow such that, excluding finance related cost and reducing R&D cost, we were cash flow neutral over the nine months of 2016. We are position to be cash flow positive on a similar basis in 2017.
Enhanced our management team with experienced additions such as Dr. Craig Granowitz, Michael Kalb and Todd Grisco. Our Chief Medical Officer, Chief Financial Officer and Vice President Managed Care respectively.
Expanded our Managed Care coverage for Vascepa, while during 2016 and leading into 2017. Surpass when 100,000 patients currently being treated with Vascepa therapy we see new chemical entity regulatory exclusivity designation for Vascepa. Reached the first of its kind first amendment agreement with the FDA supporting our broaden promotion of Vascepa.
Completed patient enrollment in REDUCE-IT at 8,175 patients with all such patients randomized on a one-for-one basis between Vascepa arm and the placebo arm of this study. In biologic as our commercial partner for Vascepa in the Middle East in North Africa.
With this increased institutional [enrollment shift] (Ph) in Amarin an amended RSPA agreement for the REDUCE-IT study, while in the process of firming FDA support for the study design and increasing the number of pre-specified secondary and tertiary endpoint to over thirty, which pre-specified endpoints should support broader publication assuming the study results are as positive as we believe is possible.
We anticipate continued progress in 2017, our strategic priorities remain firm, they are grow product revenues, advance REDUCE-IT to completion and be prepared to properly leverage successful results of the study and operate cost effectively and opportunistically.
Much as possible through Amarin team of talented and highly motivated employees and with Vascepa, our product that uniquely positioned with a broad effect on levels of lipids, lipoproteins and other important biomarkers together with its demonstrated placebo like safety and tolerability.
More over the need for affordable preventative cardiovascular therapy is large and growing. A recent report by the American Heart Association forecast cost associated with heart disease to double to $555 billion in 2016 into $1.1 trillion within 20 years.
The AHA estimates that 45% of the total U.S. population or approximately 131 million individuals within their lifetime have at least one health problem related to heart disease. 24 million will have coronary artery disease and more than 11 million will experience a stroke.
Comments from the Presidents of AHA warn that the burden of cardiovascular disease is growing faster than our ability to combat it. We at Amarin, believe that Vascepa has the potential to lessen the burden on the healthcare system presented by this disease pathology.
As you are likely aware, we commenced the REDUCE-IT cardiovascular study in late 2011, or slightly over five years ago. This 8,175 patient outcome study is evaluating whether treatment with the Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other risk factors for cardiovascular disease.
The results of this important study if successful could move promotion of Vascepa from the current biomarker data to heart outcomes data, which is what many physicians seek. Currently only a small percentage of the million of patients in the United States with Dyslipidemia that includes persistence in elevated triglyceride levels are treated with prescription therapy beyond LDL cholesterol therapy to help mitigate their cardiovascular risks.
In part, this is because such prior prescription therapies, which might be used on topostatin therapy to treat high triglyceride levels have increased LDL cholesterol or have been associated with other potentially harmful side effects. This large population of potentially at risk patients has never been studies in a global double-blind placebo controlled study such as REDUCE-IT.
We believe that Vascepa is well suited to treat this large population, because of its broad, favorable effect on lipids, its placebo like safety profile demonstrated in Phase III studies and because it is dosed orally in priced at levels which most managed care considers to be priced at parity with their cost for generic products which are our closest competitors.
Thus far, over 26,000 patients years of study experience has been accumulated in REDUCE-IT. We anticipate the onset of the target 1,612 cumulative primary cardiovascular events in REDUCE-IT study, which is the target for study completion to occur near the end of 2017. There is an interim look for safety and efficacy in the study based upon the occurrence of approximately 80% of the target aggregate number of primary cardiovascular events in the study.
We anticipate that that interim look which will be conducted by the study’s independent Data Monitoring Committee or DMC will occur during Q3 2017. Given the high threshold for stopping this study early for overwhelming efficacy, we expect that the study will run to completion with the results reported in mid 2018.
We may be better able to approximate the timing of the end of the study results after we gain an experience from the 80% interim look. This 80% interim look serves as a productive forcing function to get approximately 80% of the events in this study well documented within the study database. It also helps us maintain contact between clinical studies and patients has can be particularly important in long-term studies.
Amarin personnel will remain blind at the study results until after the study is stopped and the database is locked at either the 80% interim look, which will be the second of the two pre-specified interim efficacy reviews by the DMC or at the final analysis. As intended, there have been 18 periodic safety reviews by the DMC stake, after each of which the DMC is recommended to study continuous plan.
We are increasingly preparing Amarin for expanded promotion of Vascepa based upon our anticipated success of this outcome study. This includes planning for sales force expansion, review of potential promotional and public relations campaign and increasing inventory levels.
As Mike Kalb will discuss later. Until we have REDUCE-IT results, we are holding off on most costs associated with its expansion, including the cost of the actual expansion of our sales force, but the planning phase is important, we intend ready to make Vascepa considerably better known and more broadly used after we have such results.
With the size of Amarin sales force relatively unchanged at 135 sales representatives and our targeting relatively unchanged at approximately 20,000 physicians in select geographies in the United States supplemented by co-promotion efforts of our partner Kowa Pharmaceuticals America. We anticipate that we will grow Vascepa product revenues based upon increased productivity in 2017 to between $155 million and $165 million.
We have grown Vascepa revenues substantially in each of the past three years with essentially the same size sales force and we are confident that we will continue to see revenue growth in 2017 driven by further Vascepa prescription growth particularly from the physicians whom we are most educating regarding Vascepa.
In prior conference calls, various members of Amarin’s management team have spoken regarding different aspects of our operations, Including Aaron Berg, who has discussed our commercial growth, Steve Ketchum who has discussed our R&D programs and regulatory matters and Joe Kennedy who has discussed our patent, NCE and first amendment matters. Each of these team members are on this call today.
Before turning the call over to Mike Kalb to discuss financial matters, I have asked Dr. Craig Granowitz our Chief Medical Officer to make a few comments. As you may recall, Craig joined the Amarin approximately year ago. Prior to joining Amarin, Craig was Senior Vice President and Head of Global Medical Affairs at Merck. Craig.
Thank you, John. As referenced, I joined the Amarin approximately year ago after having considerable due diligence regarding Amarin and Vascepa, since my joining of the company my extensive excitement has only increased. Based on the medical need of patients with cardiovascular risk and elevated triglyceride, the quality and dedication of Amarin’s team, support the scientific community and the quality and direction of the science of EPA.
Our understanding of CD risk factor is rapidly evolving, based on publishers vote from a large number genetic, epidemiologic and clinical outcome studies that have been reported in the past one to two years, the role of elevated triglyceride as an independent risk factor compared to low baseline HDL is much stronger in its validation.
Along with elevated baseline LDL, high baseline triglyceride is increasingly associated as a major independent and causal factor for serious cardiac event such as myocardial infarction, stroke and cardiac death is our new and important findings in the fields of Lipidiology, diabetes, preventive and interventional cardiology and these results are currently being reported as you have seen in scientific meaning like the NLA, [ACCA] (Ph) and AHA amongst others.
The science of Omega-3 is remarkable in its scope depth and breath. As we continue to explore the science the role of Omega-3 and particularly the role of EPA is increasingly recognized as a key players in efficient and effective lipoprotein transporter metabolism, improved endothelial function in a number of inflammatory process.
These paleographic effects may play an important role in the manner in which prescription per EPA Vascepa impacts multiple [indiscernible] process in the health of patients with cardiovascular disease.
Many of these findings have been reported in more than 30 scientific publications and posted presentations that Amarin has sponsored or supported during the prior year. This level of collaboration in scientific productivity have been significant achievement for any company.
But considering Amarin’s in size and stage of corporate development, it is truly a remarkable achievement which demonstrated Amarin's commitment to scientific partnership with leading academic medical centers and researchers, asking relevant questions worthy of publication and conducting work that is rigorous and of high quality.
Among many key opinion leader, there is also a high and growing a level of excitement in the REDUCE-IT study itself. With the increased awareness of the importance of high base line triglyceride and the effect that REDUCE-IT is the first study conducted to study this population. The urgency for the results is large and growing. It's gratifying to be a part of a large multi country outcome study that has been run rigorously with the support of Hearing Committee of leading academic researchers.
The size and quality of the study and its supporters and investigators is a further validation of the population, the study hypothesis and the robustness of the ongoing study itself. Many of the researchers with whom I have spoken during the past year, have commented about why this group of patients has never previously been studied in a rigorously prospectively designed CD outcome trial, given the population’s significant residual risk profile.
While I really can't comment on why this has not been previously studied, I am proud that Amarin has taken the challenge to implement the REDUCE-IT study and I look forward to help you ensure the results of this important trail are understood broadly among key opinion leaders and the medical community at large.
In summary the importance of residual risk beyond LDL lowering therapy is becoming well recognized. If Vascepa is shown to less in this risk, this will have a very important advance of patient care, particularly given the cost and Placebo like safety profile of the Vascepa. I am appreciative of all the work that Amarin has done to design a robust study before I came to the company.
I look forward to working with the patient and professional communities to educate patients and providers regarding the importance of identifying and treating patients with elevated base line triglyceride after statin therapy and the results are the REDUCE-IT study.
Until REDUCE-IT is completed, we will continue to work relentlessly to generate additional supportive data and to continue to educate physicians, payers and patients about triglyceride, the benefits of pure EPA Vascepa and the need for healthcare providers to consider Vascepa for appropriate patients.
We envision multitude of clinical papers based on the results of the REDUCE-IT study. A paper describing the design of the REDUCE-IT study itself is anticipated to be published soon. The lead author for this paper is Dr. DeCock Bod, of Brigham and Women's Hospital in Boston. Dr. Bod is the principal investigator and chair of the steering committee for the REDUCE-IT study.
This design paper help educate the medical community regarding the criteria for the population enrolled in the study an endpoints for the study. For those of you who have followed Amarin, investor communication have mainly limited new information of paper.
But for other audiences this published paper could provide additional useful information with roughly one in four adults in the United States currently living with elevated levels of triglyceride and with millions of these patients also diabetic. A large medical need for the REDUCE-IT study of statin treated patients and the elevated risk has ever been clear.
I would now like to turn the call over to Michael Kalb, our Chief Financial Officer to review our financial results.
Thanks Craig. All four quarters of 2016 resulted in strong growth over the corresponding quarters of the prior year. During the fourth quarter and full-year 2016, Amarin’s net product revenue increased to $38.4 million and $129.0 million respectively representing increases of 45% and 59% over the prior fourth quarter and full-year 2015.
The core driver of our year-over-year increases in net product revenue was continued growth in new and recurrent Vascepa prescriptions. Net pricing in 2016 was relatively flat with net pricing in 2015. As we have stated previously, we believe that our U.S. product revenue growth will come from increased prescriptions of Vascepa, primarily generated from physicians educated by our sales team.
We anticipate net pricing in 2017 to also remain relatively flat, thus continuing to achieve approximate net pricing parity with the generic earlier generation for prescription Omega-3 product. We continue to believe that measurement of Vascepa growth compared to corresponding periods of the prior year is a better measure of our progress in evaluating consecutive quarter growth, although our Q4 2016 growth was substantial from both measures.
We emphasize comparison to prior years because we continue to experience and anticipate seasonal effects such as typical slower prescription levels in Q1 of each year as patients were slow to fill prescriptions when they encounter large, annual deductible amounts under their medical insurance plans. During 2016, whole purchasing patterns were inconsistent between quarters as they likely try to adjust to our overall growth, seasonal factors and other considerations.
Overall, we estimated that for 2016 changes in channel inventory increased net product revenue by approximately $3 million to $6 million calculated based on estimated days of inventory on hand. Most of this occurred in Q2 2016 with other quarters including Q4 2016 experiencing some decline of channel inventory levels.
These changes by wholesalers appear to be made in ordinary course as overall inventory levels at wholesalers are within industry norms. We think they are looking at inventory levels on days of inventory on hand basis makes the most sense as it incorporates some growth in inventory levels to reflect Vascepa’s overall prescription growth.
On an absolute dollar basis, the change in inventory levels is more pronounced. We comment here on this wholesalers stocking effect those who are interested reconcile our reported revenues from Vascepa prescription growth. Overtime, we believe that these quarterly fluctuations will flatten out to generally match prescription growth
In Q4 2016, normalized prescriptions for Vascepa as reported by Symphony Health were 286,000 compared to 191,000 in the same quarter of 2015. For the full-year 2016, normalized prescriptions for Vascepa were 976,000 compared to 638,000 in 2015 an increase of 53%.
As previously guided, we anticipate 2017 Vascepa product revenues of $155 million to $165 million and we anticipate seasonal factors to continue to make our growth variable from quarter-to-quarter. This guidance for 2017 product revenues assumes that to REDUCE-IT cardiovascular outcome study continues to completion and is not stopped in Q3 for overall efficacy as really stoppage of that study is unexpected.
In addition to product revenue, we recognized the licensing revenue of $0.3 million in Q4 2016 and $1.1 million for full-year 2016. Such licensing revenue relate to agreements for the commercialization of Vascepa outside the United States most of this licensing revenue came from amortization of the initial $50 million v received upon entering into our agreement with Eddingpharm from China.
During 2017, our partners in China anticipates receiving feedback from regulatory authorities on the regulatory path forward in China. We also anticipate at least one country in the Middle East to allow commencement of Vascepa sales before the end of 2017, although we do not anticipate this impact to be substantial top line growth during 2017.
Gross margin from product revenues , improved to 73% overall for 2016, this compares favorably to the 66% for 2015, this improvement was driven primarily by lower costs particularly lower cost for producing our active pharmaceutical ingredient. Other cost savings is also contributed to the gross margin improvement.
While we may see some slight improvement gross margin in 2017, for the most part, we anticipate our gross margin from product revenues to remain little changed until sales volumes get much higher at which point gross margins could approach 80% or more likely remain in the 70%.
Selling, general and administrative or SG&A expenses for Q4 2016 and 2015 were $31.3 million and $23.5 million respectively. SG&A expenses for full-years 2016 and 2015 were $111.4 million and $101.0 million respectively. The increase in SG&A expenses primarily reflects an increase in sales and marketing expenses and co-promotion fees payable to Kowa Pharmaceuticals America, Inc.
We intensely kept the sides of our sales team relatively flat in 2016 and grew based on improvements and productivity as supported by experience, broader promotion and improved managed care coverage.
In 2017 excluding commercial spending for an anticipated expansion posts successful REDUCE-IT results, SG&A expenses excluding non-cash costs are anticipated to increase by less than 10% compared with 2016 with the exceptions of increased co-promotion fees anticipated to be paid to Kowa associated primarily with the anticipated increased revenue growth.
Our intention is to significantly expand promotion of Vascepa upon positive results from REDUCE-IT. We anticipate that preparation related activities will cost $3 million to $5 million in 2017. In addition, we anticipate increasing purchases of supply for Vascepa in 2017, also support anticipated revenue growth in 2017 and to prepare for REDUCE-IT success.
Research and development expenses for Q4 2015 and 2015 were $10.2 million and $13.3 million respectively. Research and development expenses for full-year 2016 and 2015 were $50.0 million and $51.1 million respectively. This slight decrease was primarily driven by decrease in overhead costs and non-cash stock based compensation.
While we look forward to R&D cost dropping after we complete the REDUCE-IT study. Our R&D cost will remain relatively high in 2017. We anticipate that R&D expenses in 2017 excluding non-cash costs will be approximately $50 million to $60 million with the majority of such spending devoted to the ongoing REDUCE-IT trial.
We incurred past expense for 2016 of $10 million, the majority of which is noncash. Despite consolidated operations operating any loss, previsions at the subsidiary level in 2016 resulted in tax expense compared to tax benefit in 2015 of $3 million, which was largely noncash as well.
Amarin reported cash and cash equivalents of $98.3 million as of December 31, 2016. This cash balance includes net proceeds of $64.6 million from an equity financing completed in August. As of December 31, 2016 the company also had $20.0 million in net accounts receivable or $24.1 million in growth accounts receivable before allowances and reserves and $20.5 million in inventory.
Accounts receivable are current with wholesalers during 2016, typically paying Amarin in 30 days or less. We anticipate similar high quality accounts receivable in 2017, although some customers as part of an overall industry trend are seeking increased this accounts and fees which this far we have relented to pay. However, without providing these additional - accounts, their payment terms are anticipated to move closer to 60 days.
In January 2017, Amarin issued $30 million in aggregate principal amount of 3.5% exchangeable senior notes due to 2047 or the 2017 notes. And purchased approximately $15 million in aggregate principal amount of 3.5% exchangeable senior notes that were issued in 2012 [indiscernible] . The earliest at the 2017 notes can be put through us is 2022. In conjunction with this debt restructuring investors are offered to purchase considerably more debt than we deem necessary to offer.
Pursuant to this January 2017 debt restructuring on a pro forma basis at December 31, 2016 Amarin had approximately $112 million in cash and cash equivalents and $30 million in face amount of exchangeable debt outstanding. Over the last nine months of 2016, Amarin’s operations were cash flow neutral excluding cost for REDUCE-IT, financing costs, interest and royalty.
On a similar basis, we anticipate being cash flow positive in 2017 although we anticipate from quarter-to-quarter variability and our 2017 net cash trending as we for example increase supply purchases during early 2017 and navigated the aforementioned payment term matters with certain customers.
For avoiding some doubt, we appreciate that our longer term goals need to include substantially positive cash flow from consolidated operations including R&D cost. But nonetheless, we view our achievement over the last nine months of 2016 to be an important milestone reflecting our robust revenue growth and cost management.
As of December 31st, 2016 Amarin had approximately 269.4 million American depository shares or ADS and ordinary shares outstanding. 32.8 million shares equivalent Series A convertible preferred shares outstanding and approximately 21.2 million equivalent shares underlying stock options at a weighted average exercise price of $3.37 as well as 10.1 million equivalent shares underlying restricted or deferred stock units.
I will now turn the call back over to John for closing remarks. John.
Thank you Mike. Before closing, I want to thank our employees and collaborators for their tremendous contributions during 2016. I also want to thank our shareholders for your support. 2017 should be an exciting year for Amarin as we continue to grow revenues and as we prepare for the results of REDUCE-IT cardiovascular outcome study.
The excitement is strong within Amarin for these results and we sense this excitement building amongst KOLs for this landmark study. We intend to be prepared to act quickly to broadly disseminate the study results once they are known to us.
With that, we conclude our prepared comments and we would like to open the line for some questions. Operator.
Thank you. At this time, we will be conducting the question-and-answer session. [Operator Instructions]. Thank you. Our first question comes from the line of Joel Beatty with Citigroup. Please proceed with your question.
Hi good morning and thanks for taking my questions. I have two questions, the first is could you tell us a little bit about any feedbacks from physicians that might help add the perspective to the sales growth you have been seeing with Vascepa. And then the second question is could you tell us a little bit more about the timing of the primary outcomes analysis, the final outcome analysis and the timing that between when you have data in-house and when you will be able to share whether the trials succeeded or not with investors. Thanks.
Joel good morning, good to hear from you. Sure, I’ll make a couple of quick comments and then I’ll actually ask Aaron Berg and Steve Ketchum to weigh in a little bit. So with regard to physician response, I remind people, because as I’m talking with investors they often hear this these might doesn’t know much about Vascepa. So our comments about physicians come in two categories those we are actually promoting to and those that we are not promoting to.
As a reminder, we have sales force sales of about a 135 sales representatives that’s a specialty sales model and as there at parts of the country where we have good coverage, we have primarily a targeted physicians who are higher prescribers of earlier generation therapy, but this leaves a huge chunks of the country where we don’t have sales representation. Post REUDCE-IT results is our aim to expand our sales representation to cover that white space while increasing our sales promotion in the areas where we are currently calling.
So my comments are going to be limited to the docs that we call on which is a universe of about 20,000 physicians and one of the nice thing about Vascepa is that I don’t go to sleep at night worrying about being woken up with a call about adverse event. It’s a safe drug, I’m yet to find a doctor who has anything negative to say about the drug, the challenge that is with any drug is that we are new or the incumbent drugs have been out there for a while and wherein we are changing behavior.
And I think we are increasingly getting a share particularly of [indiscernible] from these physicians, there continues to be at first reaction from doctors about [indiscernible] it’s not true, but that’s the first reaction, if they get more experience with it not possibly in the Medicaid side, but in the Medicare Part B side or on the commercial side they continue to gain comfort or confidence in the product.
I’ll turn things to Aaron in a moment just to talk about that but let me just briefly on your other comment, there you are going to go straight to Steve and that is the timing of the analysis so there is multiple steps to that which Steve will go through. We did go through some of this discuss when we moved from the 60% interim look last year to the final data for that and some of that was laid out in our press release I think at the end of March of late last year.
And just a reminder we moved from the 50% of the advance to the actual read out of that by the Independent Committee that occurred somewhere in late September timeframe. So roughly a six month period, but Steve can cover that in more detail. Aaron do you want to add?
I’ll just build on what you said around the physician feedback. Hi Joel how are you? So first of it comes down to product itself, the clinical profile, physicians recognize that as being unique, they appreciate the jealous and anchor data increasingly and their experience also plays in as they use it the more they have good results the more they want to use it. And then the access, we have had good access for a long time, managed care access and that access continues to improve. So the fact that the product is different, physicians are getting good experience and they are able to get the product are what we are hearing and that should lead the future growth.
Okay, thanks Aaron and thanks Joel for questions. So to elaborate on John’s comments regarding the first interim analysis, we clearly have that experience in hand and we will have a much better idea at the timing for the final analysis following our experience with the second pre-specified interim look by the independent Data Monitoring Committee which is we are sharing today, we expect to be completed within Q3 of this year.
So to describe the process in a little bit more detail, once we get to the point where we are signaling attainment of a 100% of the pre-specified events, all patients will have to be brought back to the clinical sites for a verity of clinical laboratory and vital status measurements.
And then that information has to be entered into the database, they to be have collected, cleaned, adjudicated, summarized and then progressed following a series of internal and independent, review committee reviews to the state of being deemed appropriate for final database lock.
And then obviously after unbinding, we need to do further scrutiny through our independent review committees and operational team and our network of vendors, just to ensure that we are releasing complete and fair results.
Just to add may be obvious [indiscernible] out, we just think that there is some efficiency by having gone through this process at the same time locked in. we will see to what extent that has impact, but at the same time just as a monumental study, we are now a little over five years into it, we want to get it right. As much as we want to get that data, and we really want to get to that data, we also want to make sure we get it right, so there are a number of very important quality control steps along the way to make sure that that data is complied correctly, complied independently, remains blinded to Amarin. So we want the data, but it’s got to be done in a way that’s unquestionable.
Very good. Thank you.
Thank you. Our next question comes from the line of Chiara Russo with Cantor Fitzgerald. Please proceed with your question.
Hey guys, good morning. So a couple of question, first of all when we do get a peak at the top line data, are we just going to get the top line data or do we get to see some of those secondary and tertiary endpoint in some of the sub populations. What sort of that do we get to see there?
So I'll let Steven Ketchum weigh in on that Chiara. Good morning by the way.
So we will present top line data, this possibly done we want to preserve our very detailed findings for publication presentation and major medical congress or simultaneous publication in a major medical journal. But we will be sure to touch on the high level points that summarizes our key findings.
Yes. And both our Phase III study, MARINE and ANCHOR, I think we stroke appropriate balance there of having data that would, meaningful to investors, but also preserving what has been a very significant stream of subsequent publications. And we will be approaching it from the same prospective. We recognize that Vascepa and its study is very important to Amarin and its shareholders since that will be included in the balance.
But undoubtedly with 30 pre-specified secondary and tertiary endpoints, we are not going to get to all that from the start, but hope it’s on the primary endpoint in other base line statistics and things I think will be important towards swinging the picture of the results and then working on a broader publication from there.
Okay, that makes sense. And just a couple of additional housekeeping questions, I have noticed sort of in the revenue ramps that there is a little bit of seasonality as such stated with first half versus the second half. Do you kind of expect that to continue for 2017 as well?
We expect variability to continue yes, the first quarter in each of our years of selling has been relatively slow that’s because we believe and it’s not unique to Vascepa, deductibles for patients are beginning to get high and for drugs that are treating conditions that are asymptomatic, patients are making choices with their wallets [indiscernible] conceding not to fill certain prescriptions.
So Q1 has typically been a quarter where prescriptions picks back up in the March timeframe, but it will sort of start slowly and that often ends up getting exaggerated by wholesalers looking at the slowdowns that typically occur early in the quarter and then adjusting their ordering patterns based upon that trend and then it often rebounds the opposite way that begin to pick back up in the second quarter and wholesaler move the patterns around the opposite direction.
We don’t control all that but in terms of predicting quarter-to-quarter variability I would imagine that a lot of that probably [indiscernible] which is we encourage that folks looking at us to think of us more as year-to-year comparison as appose to consecutive quarter comparison as we think is the year-to-year comparison there are more meaningful.
Okay, I mean seasonality doesn’t exist, so it seems like it applies to you guys very well. And then the last couple of question, again a little bit more housekeeping. Does the SG&A spend have a little bit of a backend ramp, does the R&D have a little bit of a frontend weight to it and in terms of income tax expense, how should we think about that going for in 2017.
Mike correct me on some of this, but I’ll just jump into it. So, SG&A expense our size of our sales force is flat and has remained flat. There are some periodic clocks that we start new promotional campaigns, periodically there are different costs to that. We have had a variety of different legal projects over the year including matters related to first amendments, NCEs and those have had some sort of periodic sights.
We are doing some further planning for preparations for REDUCE-IT success on the commercial side and there are some project related costs there, although we have talked about the aggregate of that for 2017 being somewhere in the $3 to $6 million range. Obviously after we have success with REDUCE-IT which we believe we will have, there will be significant bump-up in SG&A related cost.
The other piece of SG&A cost that is variable by quarter is that there is a full promotion to be in there for Kowa and as our revenue grow therefore our gross margin grows and we are - Kowa 8% of our gross margin represented with 19% last year, it’s in the low 20s for this year. So the percentage doesn’t have much of an impact, but as revenues grow and as revenues might be variable from quarter-to-quarter that could have an effect quarter-to-quarter on SG&A spending.
Our R&D, our predominant spending on R&D is for REDUCE-IT and during periods of time when we are having patients coming back into the sites for vital data as Steve was describing that tends to be more cost in those periods, but we are not enrolling patients any further, but there are activities in the study, which create certain spikes, there are some cost around that analysis and at the end of the study there will be continued cost around our publication.
On the income tax side that’s largely non-cash, as a reminder our parent company is domiciled, our IP is developed out of Ireland initially while we were in the U.S. commercially we have got certain operations in the U.S. which are taxed by the U.S. tax authorities and we had an overall company that has tax loss carry forward now of over $570 million, which we look forward to utilizing here at some point in the future.
But back and forth between those various entities there are tax amounts that some get capitalized, some of it don’t, so some gets offset with various allowances and we could take offline more details of that if you are interested, but it’s all non-cash and sometimes it popped up as a provision, and sometimes it popped up as a [counter fit] (Ph) but where taxes really become important is when we get to profitable on a consolidated basis.
Okay all right. Great, guys. Thank you.
Thank you. Our next question comes from the line of Hugo Ong with Jefferies. Please proceed with your question.
Hey, guys. Thanks for taking the question and congrats on all the progress. My first question is I was curious if you have any thoughts on potential read-through from [indiscernible] trial that reported positive top line data. So I understand that it’s targeted different lipid parameter, but just curious on your thoughts if they had any to read-through to REDUCE-IT or maybe impact to visit the prescription chain? Thanks.
Good morning Hugo. I’ll ask Craig Granowitz to comment in a second, but I’ll just remind that the audience that [indiscernible] are not directly competitive, so different population, different clinical facts, certainly different co-ops and administration. And generally we think that [indiscernible] brings attention to lipid management and the importance of lipid management is a positive for us, but beyond that yes let me turn things over to Craig for further comments.
Thank you, John and thank you Hugo I think the important thing to recognize always is that LDL represents part of the risk profile that even after a management of LDL there is going to be considerable residual even under studies like IMPROVE-IT and others at lower LDL, the very low level, there is at least 70% of the residual risk remains after lowering the LDL to that level. So we expect that LDL will manage part of the issue, but that there will be considerable residual risk post LDL management.
I think the other aspect to really keep in mind with some of the outcomes studies that have come out around elevating HDL is that HDL is clearly not the answer. And I think the field is moving back to triglyceride and elevated base line triglyceride as the key driver of residual risk in addition to LDL. So we feel even more confident that the study population and we are looking at and REDUCE-IT is the right one. It is a population that has not been looked at before and we believe that a significant portion of the remaining residual risk after LDL management is driven by this high base non [TG] (Ph) group.
And as a reminder, in REDUCE-IT we are managing LDL at very low levels as the base line, and that these stations has significantly elevated base line triglyceride and as Steve as mentioned with the timing of the interim analysis, these patients are proving events at significant rates. So that we know we are dealing with the population that has considerable risk despite having LDL managed to very low levels with optimal management on a statin.
So we don’t think that PCS-K9 studies actually impact that, we are excited to see results, we are focused on improving the overall outcomes of cardiovascular patients and we believe independently managing both elevated base line triglyceride and elevating base line LDL are important for achieving results of lowering cardiovascular disease.
Got it. Okay great thank you, and my second question is, I'm just curious on how the uptake of the smaller half gram pill has been, have there been any noticeable trends here?
Hugo, still relatively early on that, we had commented on last call, I mean someone had asked the question about why you introduce that, there are certainly some patients where that’s important. It is not a product that we ever see being our dominant product, but with us moving towards hopefully both REDUCE-IT populations measured in the multiple millions or tens of millions of patients.
A small percentages can add up to an important value and I think based upon data that we have looked at somewhere in one in one in 30-ish kind of patients have potentially swallowing issues with the one gram capsule. Most do not, I take a sip every day, one gram is fine for me, but we are seeing its used, but it is not likely to be a major driver of prescription growth, but it can help some added patients along the way, so much the better.
Okay, great. Thanks for taking the questions.
Thank you. Mr.Thero there are no further questions at this time. I would like to turn the floor back to you for final remarks.
Well thanks everybody for joining us here today. I appreciate your interest and look forward to providing you continued update on the progress Amarin is making. Take care, have a great day. bye.
Thank you, this concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
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