Amarin Corporation PLC (NASDAQ:AMRN)
Q2 2016 Earnings Conference Call
August 04, 2016 07:30 AM ET
Kathryn McNeil - Director of Investor Relations
John Thero - President and Chief Executive Officer
Michael Kalb - Chief Financial Officer
Aaron Berg - Senior Vice President, Marketing and Sales
Craig Granowitz - Chief Medical Officer
John Boris - SunTrust Robinson Humphrey, Inc.
Hugo Ong - Jefferies
Greetings, and welcome to the Amarin Corporation Second Quarter 2016 Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder this conference is being recorded.
I'd now like to turn the conference over to your host, Kate McNeil, Director of Investor Relations for Amarin Corporation. Thank you. You may begin.
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 wholesalers inventories, revenues, costs and other commercial metrics; gross margins, expenditures and the adequacy of our financial resources; our current expectations regarding litigation; regulatory reviews and government agency decisions, our current expectations regarding our cardiovascular outcome study, such as timing of interim looks, study completion, regulatory review and likelihood of success, our plans to protect the exclusivity and commercial potential of Vascepa, our goals regarding international expansion and other business development opportunities, 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 4, 2016. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially. So you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreement that we may enter into, amend, or terminate.
For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statement section in today's press release and the risk factors section of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. These documents have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of Vascepa outside its approved indication. Please note that we also providing slides to accompany this morning’s call. These slides which can be found on our website www.amarincorp.com under the category Events and Presentation, which is a subsection under the Investor Relations sections of the website. These slides summarize some of key aspects 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. Thank you for joining us for an early start. We appreciate that today is a busy day with numerous companies reporting this morning, so we’re going to keep our remarks and focus and concise, first highlighting Amarin’s recent commercial, operational and financial performance and then taking questions from analysts and investors.
Similar to Q1, operating results for Q2 again exceed our expectations. The dedication focused execution of our team have resulted in our tenth consecutive quarter of greater than 50% growth in normalized prescriptions compared to the corresponding quarter of the prior year.
As a result of this positive performance and associated increases in revenue for the first half of the year, we are raising our guidance on estimated full year 2016 net product revenues through a range of $112 to $125 million. Underlying our growth in product revenue to $32.8 million in Q2 is enhanced sales and marketing productivity as we continue to control our spending, intentionally keeping spending relatively flat for the quarter. This combination of continued revenue growth and expense control allowed us to lower our aggregate net cash burn in the quarter to approximately $9 million. We remain on track to achieve our previously expressed goal of becoming cash flow positive from commercial operations going into 2017, excluding REDUCE-IT and other R&D costs not essential to our current commercial operations.
We of course are striving to ultimately become meaningfully cash flow positive covered all expenses including REDUCE-IT interest and royalties. However, we believe getting our commercial business to cash flow positive is an important milestone in our growth and we are pleased to be getting close to this milestone.
In Q2, normalized total prescriptions achieved all time high levels and continued to outpace the growth of our competitors. Total normalized Vascepa prescriptions for the quarter has reported by Symphony Health Solutions and IMS totaled 230,000 and 248,000 respectively. These levels represent increases of approximately 55% and 58% respectively over the corresponding quarter in 2015 and represent growth of 14% and 16% from the first quarter of this year.
Vascepa growth continues to be generated primarily from targeted high file physicians through focused message delivery, compelling supportive data and improved managed care coverage. This focused execution from both Amarin sales team and our co-promotion partner Kowa has resulted in growth across of broader array of metrics. Number of Vascepa prescribers later prescribing NRx, TRx switches including increased switches of patients to Vascepa from earlier generation triglyceride lowering therapies represented by omega-3 mixtures and fenofibrate products.
Drilling deeper into the data also highlight two of the reasons we remained bullish on the market opportunity afforded to us by our current indication and by our expanded first amendment marketing initiatives based upon the strong efficacy, safety and tolerability profile of Vascepa.
First, despite steady growing Vascepa market share of the overall existing prescription omega-3 in non-statin lipid therapy markets, we believe there remain millions of patients who are under treated and could benefit from Vascepa.
Second, we continue to witness as the market is sensitive to the promotional messaging of Vascepa. We are seeing accelerated share growth among those top Vascepa targeted physicians hold on by our sales team. We’ve remained relatively early on the path to educating these physicians regarding the results of the ANCHOR and JELIS studies and continue to find physicians to be interested in this information. Of course this all are build up the fact that Vascepa has been shown to work and to be well tolerated.
These trends are supported by recent market research we conducted showing that among our target top Vascepa prescribers are prescription omega-3 product, physician awareness is high and perceptions are highly favorable on key differentiating points of our product profile including efficacy and lowering triglyceride levels, lack of LDL-C increase, benefits on other lipid markers and favorable side effect and tolerability profile.
Our Vascepa related messages are strong, compelling and gaining traction. Also compelling of course is the potential blockbuster opportunity associated with our cardiovascular outcomes study REDUCE-IT.
As we’ve laid out to you before, there is significant scientific data and growing support for our confidence in the REDUCE-IT hypothesis that treatment with pure EPA Vascepa will reduce cardiovascular events in patients who have persistently elevated triglyceride levels despite stabilized statin therapy.
As I was reminding our employees recently, it is easy over the four and a half year since we began and rolling REDUCE-IT to lose site of the magnitude of what we are seeking to accomplish for the study. If this study is successful, I believe it could represent the most significant breakthrough in the treatment residual cardiovascular risk since the advent of statin therapy. Cardiovascular disease is a number one cause of death in the United States. Hundreds of billions of dollars are spent each year treating patients for stroke, MIs and other cardiovascular events.
Statins and other therapy for lower LDL are terrific. However, significant residual risk remains. Headlines coming out of the American College of Cardiology Annual Scientific Session earlier this year emphasis that part effort to addressing this residual risk by focusing on HDL therapy have been flawed and that the next frontier is triglyceride management. Amarin is at the forefront of that frontier with REDUCE-IT. We have earned this position through extensive data analysis and by having a drug that review as a unique and ideal add-on to statin therapy such as Vascepa does not increase LDL and has a very favorable safety and tolerability profile.
For higher generation therapies, for lowering triglyceride, increase LDL and/or has side effects that have limited their use. We believe that we not closing internet [indiscernible] with the right drug in the right patient population. We’ve remained confident that REDUCE-IT disposition for success, we remind you that this is a study that the FDA has purged us to complete as the patient population is larger and is never been respectively studied.
Today, we also announced having reached agreement with the FDA on an amendment to the REDUCE-IT special protocol assessment for FDA. This amendment does not change the primary end point or the overall size of the REDUCE-IT study or the company’s prior guidance on timing. However, the amendment is helpful in various ways.
As REDUCE-IT has been conducted over the past four and a half years, outcome studies of other therapies in other areas have been completed in undergone regulatory review. In evaluating those results, we remained confidence in the robust design of REDUCE-IT. Prior to the first pre-specified interim efficacy analysis, we wanted to incorporate modifications within the protocol and to confirm that the FDA remains in agreement with critical components of the REDUCE-IT protocol and analysis plans.
As disclosed, key changes include finalized details of this critical analysis plan covering both the final and interim efficacy analysis. The addition of a second pre-specified interim efficacy analysis had approximately 80% of the 1,612 primary cardiovascular events targeted for completion of the study and the addition of select new pre-specified endpoint expanding to over 30 the number of pre-specified secondary and tertiary endpoints now included in the trial to more full capture the broad potential benefits of Vascepa across the diverse nature of the patient population being studied.
Despite the addition of a second interim efficacy analysis and the potential second opportunity for earlier readout of the trial, we reiterate the most likely course in the course that we expect is the data monitoring committee to recommend continuation of the study through its plan completion of 1,612 cardiovascular events.
The addition of the 80% interim work does two things. First, it allows for a second formal unblinded interim efficacy and safety analysis by the DMC between now and the anticipated completion of the trial. While we don’t expect say to stop early, it would to be unfortunate to miss the potential opportunity to have data earlier if the results in favor of Vascepa are overwhelming at 80% of the events. Second, the 80% interim look is also expected to ensure that 80% of the final dataset is locked before study completion potentially accelerating the time to final data separation and publication. So in two ways this modification potential releases to earlier study results.
In addition to the publication opportunities related to the primary endpoint of composite MACE, we believe there is significant potential value to having a broad array of pre-specified endpoints to support publication and communication with healthcare professionals.
Amarin continues to be prolific in publication of results of our clinical trials and other research. Last year, we supported over 20 scientific publications and postures. We are in track to exceed that total this year. For example, we are pleased to support Dr. Lori Mosca and her presentation of data from a subgroup analysis from our MARINE study that further characterize the favorable efficacy and safety profile of Vascepa in women. We look forward to continuing to support her work and hope to have a related analysis from the ANCHOR study before the end of the year.
Likewise, we are pleased to support Dr. Eliot Brinton’s presentation of his analysis ANCHOR data, showing Vascepa’s reduction of concentrations of potentially atherogenic lipoproteins in patients with Type 2 diabetes and persistent high triglyceride levels despite statin therapy. This data was presented at the Annual Meeting of the American Diabetes Association.
As a reminder, 73 presentations in ANCHOR had diabetes at baseline. We anticipate that a substantial portion of the patients enroll and reduce it will have also diabetes.
While the onset of the 1,612 cardiovascular event in REDUCE-IT isn’t anticipated until next year. We are increasingly planning for anticipated expansion following REDUCE-IT success. These plans are evolving. However, shareholders often ask about our vision to capture this large opportunity. Our comments that while we need to REDUCE-IT results before committing to significant expansion. If REDUCE-IT is positive, we would expect a sizable increase in our sales team, this will facilitate us feeling in much of a white space in the country where we don’t current have coverage and other wide expand the targeting and frequency of our sales cost for Vascepa.
Currently our Vascepa promotion doesn’t not include a broad base direct to consumer or DDC program. We will plan to embark upon a DDC program after we have REDUCE-IT results in the appropriate regulatory feedback.
While planning on one hand, focuses ensuring that Amarin controlled its own destiny and can be successful on its own. On the other hand, out plans included valuation of whether Amarin’s growth and value would be best achieved in coordination with others. Intentionally, our co-promotion relationship with Kowa is scheduled to end after 2018. I say this intentionally not because of any concern about Kowa but rather to express that we’ve constructed considerable flexibility in our agreement with Kowa. We will continue to plan and evaluated our alternatives.
We already have an established high quality supply chain, good managed care coverage and tremendous support from Kowa [ph]. I am sure that we will talk further about our plans beyond REDUCE-IT success as we are closer to completion of the study.
For now, our primary focus remains on revenue growth with our current indication, completing REDUCE-IT, opportunistically expanding and pervasively controlling costs.
Before I turn the call over to Michael Kalb, our recently hired Chief Financial Officer to review our financial results, I would like a take a moment to welcome Mike to Amarin. He brings over 20 years of experience having previously served as Chief Financial Officer of Taro Pharmaceutical. He is already contributing and with no doubt be an asset as we execute on our strategy. Mike?
Thanks John. I am very pleased to be part of the Amarin and look forward to working with the team to help build upon the company’s progress and positive momentum. As Kate mentioned at the start of the call both our most recent 10-Q and today press release can be found on our website. In them you can find more detailed discussion of our second quarter and year-to-date financial results and the highlights I’ll cover in this morning’s call.
Overall the second quarter was a strong quarter for the company and both our quarterly and year-to-date results underscore the tremendous growth the company has experienced since last year. Further, as our increase in full year guidance suggest, we see the underlying trends in the business providing the backbone for continued growth in our existing commercial business.
During the second quarter, Amarin’s net product revenue increased to $32.8 million and 85% improvement over the $17.7 million reported for the second quarter of 2015. This brings net product revenue for the first six months of the year to$58.1 million compared to $33.3 million for the first half of 2015, an increase of 75%.
The core driver of our year-over-year increase as a net product revenue was continued growth in new and recurring Vascepa prescriptions. As John mentioned, this market our tenth consecutive quarter of greater than 50% prescription growth over prior year periods. In addition to our robust organic growth, our business like others is impacted by variability and the level of inventories of our product held by wholesalers.
Inventory levels at wholesalers and to fluctuate based on prescription trends and seasonal and other factors.
During the first quarter of this year, we saw a decrease in wholesaler inventory levels compared to year-end 2015. In the second quarter, this trend was reversed and wholesaler inventory levels increased. The wholesalers made these two purchases from us on the same terms and as a same pricing as they did in Q2. This upward trends occur throughout Q2 and was not driven by any individual large orders at quarter end.
For the six months period ended June 30, 2016, we estimate that the impact on product revenue on the net overall increase in wholesaler inventory was approximately $1.5 million to $1.8 million. On a quarterly basis, we estimate that in Q2 2016, the net overall increase in wholesaler inventory levels compared to Q1 2016 added approximately $2.9 million to $3.2 million to our reported revenues for the quarter. In contrast, we estimate that Q1 2016 revenues were approximately $1.2 million to $1.5 million lower due to a net overall decrease in wholesaler inventory levels during Q1 compared to year-end 2015.
During the same six month period last year, the impact of fluctuations in wholesaler inventory levels was more modest with lowering net wholesaler inventory levels decreasing revenues by less than $1million. Of course, our overall TRx levels are now larger which magnifies the dollar amounts as changes.
As you can appreciate, wholesalers purchase decisions independent of Amarin. History suggests that their inventory levels will vary from period to period. While overall wholesaler inventory levels at the end of June were not side of typical ranges, they were at the higher end of these typical ranges. If these wholesalers deceases the inventory levels in Q3 or Q4, it could have a dampening effect on reported revenue growth for such periods. While we can’t predict the timing of quarter to quarter variations in wholesaler inventory, we have including consideration for the level of overall wholesaler inventory at June 30th and our updated increase 2016 product revenue guidance.
As John mentioned, our current guidance since that total 2016 net product revenue will be between $112 million and $125 million. This is an increase from prior guidance which was from net revenue in a range of $105 million to $120 million. We reiterate our guidance that we are on track into 2017 cash flow positive from commercial operations excluding R&D expenses not required to sustain current commercial operations, interest and royalties.
In addition to product revenue, you will note we recognized licensing revenue of $0.5 million in the six months ended June 30, 2016 related to agreements for the commercialization of Vascepa outside the United States. Most of this licensing revenue came from amortization of the initial %50 million we received upon entering into our agreement with adding it.
Also included as amortization of small differed revenue amounts due to document filings with regulatory authorities and for entering within distributor for Vascepa in the Middle East and North Africa. We continue to be active in discussions with potential partners regarding opportunities Vascepa in other areas of the world.
In China we have been notified by the China Food and Drug Administration that our clinical trial application was accepted and we now wait their determination on additional clinical trial requirements to support approval. Based upon our current agreements, we anticipate approximately $1.1 million in licensing revenue will be recognized in aggregate during 2016 including the $0.5 million already recognized in 2016.
We maintained the 73% gross margin on product sales reported last quarter. This compares favorably to the 64% gross margin reported for the three and six months ended June 30, 2015. This improvement continues to be driven primarily by lower active pharmaceutical ingredient cost.
Overall SG&A expenses in the first half of 2016 were $54.1 million versus $50.8 million reported for the same period for the same period in 2015. The increase was primarily the result of increased co-promotion fees earned by Kowa as well as an increase in non-cash stock based compensation expense partially offset by a decrease in legal fees.
We continue to expect SG&A cost in 2016 to be substantially consistent with 2015 expenses with the exception of non-cash cost and anticipated increase increases in the co-promotion fees associated with our anticipated increases in that product revenues.
R&D expenses for the first half of 2016 increased approximately $1.7 million from the prior year, coming in $26.3 million for the six month period. This increase in expense was primarily driven by the timing of REDUCE-IT expenses.
R&D costs in 2016 excluding non-cash costs are expected to be similar in aggregate to 2015 with quarterly variability due to the timing of REDUCE-IT related costs.
Under GAAP, we’ve reported a net loss applicable to common shareholders of $13.4 million in the second quarter of 2016, or basic and diluted loss per share of $0.07. This included $3.4 million in non-cash share based compensation expense and a $5.8 million non-cash gain on the change in fair value of derivatives. Excluding non-cash charges for share based compensation and non-cash gains to the changes in fair value of derivatives, our non-GAAP adjusted net loss was $15.8 million for the second quarter of 2016, or non-GAAP adjusted basic and diluted loss per share of $0.09 compared to non-GAAP adjusted net loss of $27.7 million from the second quarter of 2015, or a non-GAAP adjusted basis and diluted loss per share of $0.15.
For the six months ended June 30, 2016 under GAAP, we reported a net loss of $43.1 million or basic and diluted loss per share of $0.23. This net included $7 million of non-cash share based compensation expense and $4.6 million non-cash gain on the change in the fair value of derivatives.
Excluding non-cash charges for share based compensation and non-cash gains due to the change in fair value of derivatives, non-GAAP adjusted net loss was $40.7 million for the six months ended June 30, 2016 or non-GAAP adjusted basic and diluted loss per share of $0.22 compared to non-GAAP adjusted net loss of $56.3 million for the six months ended June 30, 2015 or non-GAAP adjusted basic and diluted loss per share of $0.32.
We ended the quarter with cash and cash equivalents of $72.5 million. Net cash used in operating activities for the second quarter of 2016 was $9 million. This is significant decrease compared to $25.6 million in the corresponding quarter of 2015 and as a result of increased collections due to higher revenues which resulted in decrease net loss.
I will now turn the call back to John Thero for closing remarks. John?
Thank you, Mike. Looking ahead, in addition to update on continued commercial progress, the conduct of the 60% interim look by the DMC is vast approaching. Our research support network assures us that the date should be ready for review by the DMC as early of September in that later than October. When the DMC completes its interim review, they will hand us a piece of paper recommending either to continuous plan or to stop the study. Once we know its recommendation box is checked, we will make the information public. Amarin personnel will not receive the underlying data leading to this recommendation.
Everyone involved in the conduct of the study assures me that their confidence in the quality of data REDUCE-IT can generated. We all want to ensure that the trial results is robust. We all agree that the study should only be stopped early if the result with respect to the primary endpoint is robust meeting them remote, challenging statistical hurdle of P less than 0.0076 at the 60% interim look and if this result is supported by robust and consistent data across key secondary endpoint. We remained focused, motivated and confident. I look forward to providing further updates on our progress.
With that, we conclude our prepared comments and we’d like to open the line for some questions. Operator?
Okay, while we wait for our first question to be queued from the operator, let’s take a question that was submitted via e-mail. We received a number of quarries related to the status of REDUCE-IT and the upcoming interim analysis most of which were address directly in the call, if your investors have enquired specifically about the status of database loss for interim analysis, so John perhaps you could just clarify on this point?
Sure. Relative to the database look and the interim look, you know that’s a process that’s being handled independently of Amarin personal. At this point in time, the database is not locked. My understanding is they are going through process of investigating and evaluating data quarries, it’s very common for clinical studies at this stage. Last update I had roughly a 1,000 data enquires that there are still working on, that’s down from about 3,000 a few week ago. When they get to data to the point where they are feeling comfortable with it, there will be codes that get unlocked which then applied to that data and separate the data between those stations which are on placebo versus those patients which are on Vascepa and then the date will be presented to the data monitoring committee to their review.
But at this point in time, they are still going through the date quarry portion, they’ve not separated the date between placebo and Vascepa and the database is not locked. As I said in my earlier comments, we anticipate based upon their feedback that they should be in a position to do this as there are only sometime in September, not later than October. We’re obviously looking forward for that update. We have as a reminder and through this process, multiple times previously for safety and not an efficacy look but for safety and each time this process has worked well and the result has been continued its plan. There is at this interim look a safety review and efficacy review, it will be the first efficacy review, there is not a futility analysis.
Thank you. Our first question comes from the line of John Boris of SunTrust Robinson Humphrey. Please proceed with your question.
Thanks for taking the questions. John, you mentioned on reduced - thanks for the transparency at least on database lock and the timing around that. First question just has to do with the 3,000 quarries you indicated there about two thirds of the way through those are have about 1,000 left. Can you give maybe any color on timing around resolving those additional 1,000 quarries that are still outstanding?
And then secondly on REDUCE-IT, you clearly indicated that the protocol modifications that were made along with the FDA has some beneficial impacts I think you last outlined three things, can you give a little bit more granularity on you know the modifications that have been made here?
I can try all those. Relative to the quarries, we don’t the details of what - in the specific quarries, this is normal, we are conducting this study at 450 sites across the 11 countries. There are language translations, there are following up to ensure that that are appropriately characterized even things like cardiovascular that’s different level of it, it is an immergence there is lots of different details for people to follow up on. We’ve got an experience team working through it, we are intentionally not getting into that level of detail and they are hearing us that they have this ready for the data monitoring committed to take a look at in September or October.
So at this juncture, we feel that everything is on track but we again have very limited visibility into the day-to-day portion of that, a 1,000 seems fairly like big number but actually given this quite magnitude of this study, it is really not.
With respect to the modifications of the SPA, I think the important points here before I talk about the modification. It is that we remain confident that this trial design is robust. We judge that based upon our valuation of our advisors, based on the fact that the advance rate within the study is very much tracking to our original expectations, you’ll often see cardiovascular outcome studies get to laid and companies come up with various reasons for that but often it suggest that the trial design maybe not have been as robust as had been anticipated. Our trial design appears to be robust. We have also then looking reviews of studies that will come out for other drugs and other areas to make sure we are not overlooking anything. And that is also added to our confidence in the study.
So relative to the change, we had an overall statistical approach that statistical approach we wanted to lockdown the details on. Those details included things like what, how do you look at the data at the interim look. There was discussion about say what the primary endpoint is but how do we look at those secondary endpoint. Is there any single secondary endpoint at an interim look which we statistically had to meet in terms of our hurdle to get over just stop the study early. And the conclusion there was no that is there is no individual secondary endpoint that we need to get over, but that the judgment of the data monitoring committee should be employed to look, assuming that in the scenario where the primary endpoint work have achieved that statistical hurdle about 3.0076 something less that is a challenging bar for a lock. But if we were to over that then you start to looking at the composite may 10 points and there was a data to whether we had to have statistical significance on any of those individually. And the answer was that’s not required individually but that’s the data monitoring committee should be looking holistically to ensure that there is that the data supporting the primary endpoint is robust and consistent. We would be this far in this study and stop literally and leave question marks because of inconsistencies in some form of underlying data.
Not suggesting there would be, we aren’t seeing the data but that’s the type of discussion that went on relative to some of the details in the statistical analysis plan. Relative to end points, you have seen we’ve been very prolific in publication endpoints, publication results around MARINE and ANCHOR we’re still publishing on those studies, that data has been terrific and we wanted to ensure that assuming success of reduce it that we have the ability to broad the publish on those results as well. So we added additional endpoints, we also added additional sub-populations you know that would because they are pre-specified we believe better support publications.
Some of those added endpoints get into subgroups of the composite endpoint, some of them get into glucose or diabetes related endpoints, just more detail to ensure that we have data that will allows us to be able to present robust results and to better understand those results.
And of course the added interim look which is I commented on earlier is something that it’s not uncommon for cardiovascular outcomes, they are more than one interim look we think it’s very little alpha hit relative to added that interim look and that’s with the timing of sometimes the middle of next year, we thought that that was work to trade on it having another goal as I say for lot of spend was worked. We still the problem most likely to go completion of about to stop early we think that will be valuable to patient care, valuable to the company. And even if we don’t stop early at that with 80% interim look, is having 80% of that data locked down early helps us at the end of the study. So that’s a little more detail, hopeful those comments were useful.
That’s helpful, John. Just on publication related question on REDUCE-IT, will the - I think you are attempting to get a trail design paper on REDUCE-IT published, any update on the timing and a little bit will the paper include the amendments that were agree to with the FDA upon publication?
And then just a couple of commercial questions. If you look at the FDAs, can you just tell us what the position is from the FDA on the use of Vascepa rate going forward, I think there is about 21 million that have been prescribed for fenofibrate and 2015 that’s down 5% from about 22 million plus. What are you doing commercially to capture some of fenofibrate users and get them to be transferred across to Vascepa because of the label for fenofibrate?
And then just on your sales force, you indicated you would dramatically increase the sales force if it was positive, can you help us understand sizing of the sales force, possible partnering of your sales force with another sales force out that of Kowa that maybe have some cardiovascular expertise, sharing of large pharma’s assets with your assets that co-promote with you, those types of scenarios around a potential partnership post breaking of the co-agreement?
Alright, that’s quite mortgage broader question. Let me see if I can address them. Regarding the publication, we’ve been publishers, we believe that publication and providing information is valuable. We particularly now with the statistical analysis finalized, think that it’s getting the result published. You know the design published of the REDUCE-IT makes sense. That’s entirely within our control, it’s really a publication that the timing of which really is heavily dependent on the principal investigator and the publisher. So we are going to continue to urge if that gets done but we think it’s valuable. We’ll continue to support that and trying to nudge that forward but can’t predict the specific timing, only say that we are trying to get that - trying to get that done. We’d agree that would be helpful.
With respect to fenofibrates, the FDA did cut back on the label of fenofibrates to and removed from that label that they were approved for use some statin therapy, this follows their appealed studies and which was low HDL population. The core study whereby they didn’t hit its primary endpoints and was probably part of the reason why I was setting earlier that there is less confidence in HDL as effective biomarker and more focused on triglyceride here going forward. So that label has been put us back, that product generic at this point in time. Docs been using it for years. We’ve not done head-to-head studies against that particular product but we continued to emphasis our message broad protein benefit not - no LDL increase and certainly fenofibrate have LDL increase. And here we are seeing increasing switches from fenofibrate to Vascepa. And of course the safety profile of Vascepa which is foreseeable like it is in contrast to any of our competitors certainly fenofibrates which have a verity of different complication associated with them that you don’t see with Vascepa.
So we overall think that we will continue to see ourselves taking market share from fenofibrates from the earlier generation omega-3. But I’ll you also remind you that this is an underpenetrated population overall, so that our biggest opportunity is new patient starts in market expansion, we are getting - our greatest role today is coming through new patient starts and with REDUCE-IT success, we view this is an opportunity to certainly continue to take market share from the earlier generation therapies. But more importantly to expand the type, less than 5% of the patients with high triglyceride are treated and be able to expand that type by providing data to medical community and patients which supports the effectiveness in effectiveness of Vascepa really not trying to validate triglyceride in independent.
The effectiveness of Vascepa and improving cardiovascular outcomes, we think will be a real driven in terms of both the expansion of the market share but expansion of the pile overall.
With respect to sales force post REDUCE-IT success, we are doing fair amount of work in terms of that planning at this point in time but I am controlling our costs. We want to see REDUCE-IT results before we’re moving out the paradigm what we are currently are relative to control spending. We think that there is significant addition revenue growth that we can have with our current paradigm prior to the REDUCE-IT results.
The size of that sales force, we need to see the results of REDUCE-IT to fit on to be optimal probably likely somewhere in the 400-500 sales rep range. We certainly can do that on our own, at the same time there is plenty of other companies out there who have existing sales forces in the managed care that we could co-partner with or otherwise leverage to expand our market presence. So we’ll be considering all options I think the most important to us is that we will be ready, we’ll have a nice way to approach as who the targets are, right idea is that where our existing share force can be affective and then we will review our alternatives including doing ourselves but also working with others to get there. I look forward to that challenge.
Thank you. [Operator Instructions] Our next question comes from the line of Hugo Ong with Jefferies. Please proceed with your question.
Hey guys, thanks for taking my question and congratulations on a great quarter. Maybe just a quick one question, if you could discuss maybe which geographic regions you’ve been targeting already and which new territories you’ll be focused on next?
Hey, Hugo, thanks for the question. I’ll turn that one over - here are verity of people from Amarin, I’ll turn it over to Aaron Berg, who runs sales and marketing for us. Aaron?
Thank you, John. So right now with a 130 sales reps as you can imagine, we are focused on major metropolitan areas. We have a lot of voice base in the country but we target the highest deciles omega-3 prescribers are also prescribers of fibrates. So fortunately we have a very efficient structure, very efficient alignment where we can get to a bulk of the prescriptions out there in the market through those physicians. But still be very focused in our geographical alignments.
As we move forward of course and get into to a post REDUCE-IT area, that will changes you can imagine as John commented on earlier, we’ll expand and that will of course reduce our white space to number of areas well beyond some of the major metropolitan areas.
Okay, great, that’s helpful. And just on REDUCE-IT, for the second interim efficacy analysis, can you disclose the efficacy bar for stopping the trial?
This is John. So similar to at 60% interim look, at the 80% interim look, there will be a statistical hurdle relative to the primary endpoint but also if we hit the primary endpoint, the data monitoring committee will look at secondary endpoints into a robustness and consistency. The statistical bar at the interim look relative to the primary endpoint is be less than 0.0 to 0.2.
Okay, got it. And you touched on this already but I just had a follow-up. So on adding you are over 30 pre-specified secondary and tertiary endpoints, can you discuss sort of which endpoints you see as the most important and clinically MACE?
Certainly primary endpoint which is composite made is the most meaningful, but then below that each of those components of MACE, so mortality, total mortality, cardiovascular death, stroke, MI, revascularizations and looking revascularization like type. But beyond that you get into things like total CV events and on test for heart failure and diabetes and hypertension and verity of other lipid and lipoprotein you kind of markers but the composite may definite and it’s individual components it would be the most important.
Got it, okay. And I think you mentioned that you have a subgroup analysis the men and women for you ANCHOR study similar that you did with MARINE, is any good target meeting that we expect the data?
Let me turn that over to Craig Granowitz, who runs medical affairs for us. Greg?
Yeah, thank you. We’re certainly are preparing data for AHA and that’s certainly that’s one of the topics that we are looking at. Again it would in appropriate for us to comment because ultimately AHA makes a decision and send it for us of what they will accept. We are certainly submitting a host of different data to the AHA meeting and hopefully AHA will view those submissions favorably. I think those topics that John mentioned during his prepared remarks are certainly those areas that we continue to explore scientifically and we think that there is a significant appetite in the medical community to accept those kinds of data submissions and have those data available at AHA.
Okay, great. Thanks for taking my questions.
Thank you. Ladies and gentlemen, we had come to the end of our allotted time for questions. I’d like to turn the floor back to Mr. Thero for final concluding remarks.
Many thanks everybody for joining us today. I think Amarin is making a very good progress and we look forward to continue to update you on that progress. Thanks and good day.
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