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Amarin Corporation plc (AMRN)

Q3 2013 Earnings Call· Thu, Nov 7, 2013

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Transcript

Operator

Operator

Greetings and welcome to the Amarin Corporation Third Quarter 2013 Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder this conference is being recorded. It is now my pleasure to introduce your host, Mr. Joe Bruno, Director of Investor Relations for Amarin. Thank you, Mr. Bruno. You may begin.

Joseph Bruno

Management

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 financial performance and plans for commercialization of our approved products, including supply-related activities and levels of expenditures and revenues and the adequacy of our financial resources; our current expectations regarding regulatory filings; our upcoming PDUFA date; government agency decisions and potential indications; our current expectations regarding our cardiovascular outcome study and the potential implications of such study on our regulatory process; plans to protect the commercial potential of our product candidates and approved products through patents; regulatory exclusivity; trade secrets and existing manufacturing barriers to entry; our current expectations regarding potential strategic collaborations; and our expectations for future publication and presentation of our study data. These statements are based on information available to us today, November 7, 2013. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. So you should not place undue reliance on these statements. Actual results or events could differ materially. We assume no obligation to update these statements, as circumstances change. Our forward-looking statements do not reflect the potential impacts 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 statements section in today’s press release and the risk factors section of our most recent Form 10-Q, each of which were filed today with the SEC and are available on our website, amarincorp.com. We encourage everyone to read these documents. This call is intended for investors of Amarin and is not intended to promote the use of Amarin’s Vascepa outside its approved indication. Finally an archive of this call will be posted to the Amarin website in the Investor Relations section. I’ll now turn the call over to Joe Zakrzewski, Chairman and Chief Executive Officer of Amarin.

Joseph Zakrzewski

Management

Thanks, Joe. And thank you to everyone on the line for joining us today. I’m joined on today’s call by John Thero, Amarin’s President; Steve Ketchum, our President of R&D; Joe Kennedy, our General Counsel; Mike Farrell, our Controller; and Joe Bruno, our Director of Investor Relations. Most of our comments on this call will pertain to our commercial growth, financial results and efforts to expand the Vascepa label to cover the ANCHOR indication. Given recent events, I will begin with an overview and update on regulatory matters with the FDA regarding the ANCHOR indication and then provide you with a commercial update, including our Q3 results. Steve Ketchum and Joe Kennedy will then expand on our regulatory position with the FDA regarding ANCHOR sNDA. John Thero will then speak to our reset reorganization and our efforts to grow and expand our sales efforts. Mike Farrell will review Amarin’s financial performance and three and nine months ended September 30. And lastly I will provide some closing comments before fielding questions from analysts and investors as time permits. Before I go into our commercial update I wanted to spend time talking about our FDA interactions. I want to be clear that our intent is to collaborate with the FDA regarding the sNDA for ANCHOR. As you will hear we have taken action to advance interest to seek this expansion of the Vascepa label and have every intention of vigorously pursuing this call as we feel we’re in the right. If we’re unable to convince the FDA of this and these efforts fall short we will not be hesitant to pursue alternative measures and to fight for what we believe is in the best interest of the company and shareholders. Joe Kennedy will go into those alternatives in more detail. Today Amarin…

Steven Ketchum

Management

As Joe mentioned, we clearly have a fundamental difference of opinion with FDA’s view conveyed at the Advisory Committee meeting and confirms in their October 29 letter rescinding our SPA for the ANCHOR trial. The AdCom panel were convened by FDA and the flow of the meeting was directed and controlled by FDA fo0r its review purposes. We believe that the focus of the AdCom should have been on Vascepa’s modification of triglycerides and other lipids in patients who despite optimize statin therapy have triglycerides of 200 milligrams to 500 milligrams per deciliter as demonstrated in the ANCHOR trial. Instead the FDA at its discretion directed the Advisory Committee to evaluate whether Vascepa results in ANCHOR were likely to translate to a reduction in the risk of cardiovascular events in statin treated patients with mixed dyslipidemia. Amarin did not seek an indication for CD risk reduction in the sNDA for ANCHOR. It was never the intent of the ANCHOR trial to address the question posed to the panel, nor do we believe it was fair to ask the panel to try to extrapolate such a CV risk reduction conclusion from the ANCHOR results. Based upon how the question was phrased, the panel essentially had no choice but to vote no in advance of the completion of the REDUCE-IT cardiovascular outcome study. FDA expressed that results from ACCORD-Lipid and AIM-HIGH trials as well as the publicly presented results from the HPS2-THRIVE trial failed to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients. We do not believe this is a completely accurate view of these data. In particular, we do not believe that the three cited studies provide substantially new scientific information with respect to the treatment of patients in the at-risk high-triglyceride…

Joseph Kennedy

Management

Thank you, Steve. As Joe mentioned earlier, we believe that FDA did have a valid basis to rescind the ANCHOR trial. We know that the very reason the Congress enacted SPA provision and the FDA Modernization Act of 97 was to eliminate what was known as the moving target syndrome or repeated changes in FDA’s advice about studies needed to obtain FDA approval. We, of course, do recognize the FDA’s authority, its degree of discretion on scientific matters and its current position. However the question is whether Vascepa is efficacious in reducing CV risk in REDUCE-IT existed at the time the division and Amarin entered into the ANCHOR SPA in July 2009. At that time, FDA’s decision was based on a package that included data specific to Vascepa. The question of whether Vascepa will have a meaningful CV risk reduction benefit on patients remains, in our view, substantially unaffected by recent data. For a highly purified EPA product like Vascepa, that question can only be answered by the REDUCE-IT trial. With the support of a nationally recognized and experienced team of outside legal and regulatory advisors we have formally appealed FDA’s decision to rescind the ANCHOR SPA. We are pursuing this effort vigorously. We plan to continue to pursue this effort until it is clear to us that we’ve exhausted all reasonable paths forward. The appeal process can be lengthy. It involves bringing before FDA that sequential and increasing levels of authority are a case for reconsideration. We have requested a meeting at a high level within FDA. And if that meeting request is not granted, we will adjust our plans accordingly. And according to a new FDA guideline, the documents we filed today include written arguments detailing why we believe FDA was wrong to rescind SPA. Our goal is…

Joseph Zakrzewski

Management

Now I’ll turn the call over to John Thero who will provide you with comments our recent reorganization as well as on efforts to maximize our revenue growth going forward. John.

John Thero

Management

Thank you, Joe. In response to the recommendation of FDAs advisory committee and the challenging pathways for approval of the ANCHOR indication expressed by the FDA in connection with that meeting we announced on October 22 that Amarin would reduce staffing worldwide by approximately half. This has been done. The reduction in force, affected all functions of the company and resulted in the immediate elimination of approximately 200 employees. This decision was not an easy one and created much sorrow amongst the Amarin family, because they have to say goodbye to many good people. While this is not the direction we hope to take. Post AdCom, at the end of the day, we felt that was the wisest decision for the company and its shareholders. Nobody should interpret the reduction in force that announced in October as suggesting in any way that we are not actively and aggressively pursuing approval of the ANCHOR indication. While only about a month ago we retained four times the staff level of a year ago we believe that we are adequately staffed to support Vascepa in the commercialization of the MARINE indication while pursuing an expanded indication for Vascepa. In the event that the ANCHOR indication is proved this year for any time in the future is challenging than it now appears, we would look forward to welcoming many of these employees back into the Amarin team. Amongst this reduction of staffing we are up about half of those supporting the sales effort for Vascepa in the field, leaving us with a field team of about 150 sales professionals including slightly more than 130 sales representatives plus sales management. In determining what the ideal sales force side is moving forward, we put much consideration into what was learned over in the past nine months…

Michael Farrell

Management

Thank you, John. I will now provide some commentary regarding our financial results. You will find a more detailed discussion of our results in our 10-Q and press release issued earlier today. We reported net product revenues for the quarter ended September 30th, 2013 of $8.4 million and year-to-date product revenues for the nine months ended September 30th of 16.2 million. Cash collections from the sale of Vascepa in the quarter ended September 30th, were approximately $9.1 million for a total of $18.5 million quite different wholesalers since the launch of placebo. Cost of goods sold during the quarter ended September 30, 2013 was $3.7 million. Gross margin as a percentage of net revenues improved from 56% in Q3 of 2013 but compared to the 48% in Q2 and 45% in Q1. The majority of the Vascepa capsules including cost of goods sold for the nine months ended September 30, included API that was sourced from a single API supplier. Amarin’s purchase of the API from this supplier in 2012 and early 2013 are at a higher cost per kilogram level than expected future purchases from this supplier. The unusually high cost of goods, as a percentage of revenue, is attributable to a number of things, including the geographic location of our suppliers, exchange rate exposures and lower volume and less favorable economic terms than those with other manufacturers. We expect our steady state gross margin percentage to approach to the high 70%s to low 80%s as we increase purchase volumes and source lower cost API. We also expect gross margins in the 60s based on scheduled API cost savings alone and also anticipate further growth with increased purchase volume. Under U.S. GAAP, we reported a net loss of $48.9 million in the third quarter of 2013 for basic and…

Joseph Zakrzewski

Management

Thanks, Mike. To expand briefly on our financial situation, we feel good about where we currently stand with regard to cash and cash burn. While raising capital in July of this year was not ideal, one thing we made certain to do was to raise an amount of cash that would set us up for success in almost every possible scenario. With the $226 million in cash we have as of September 30 and the recent reductions in staffing and expenditures, we believe we are in a position where, in most scenarios, it is possible that we can get to a cash flow positive position without ever having to raise additional funds. So what’s next? We will continue to drive sales of Vascepa in the MARINE indication. We will continue to expand our managed care access, converting Tier 3 to Tier 2 status. We will continue to explore areas where we can continue to reduce expenditures. We will continue the REDUCE-IT trial, as we await the FDA decision on ANCHOR at which point we will evaluate and determine the best course of action. As we discussed we won’t be in a position to share every detail of our activities to vigorously pursue the ANCHOR indication and we can’t guarantee success but we’re doing all we can. We’ve tried in our comments to be as transparent as possible regarding our plans to vigorously pursue approval for ANCHOR indication. While I expect that you may have additional questions I remind you that this is an ongoing process and we don’t want public communication of our arguments or strategy to undermine our efforts before the FDA and accordingly we will be limited at this time in providing much additional detail. Once again the level of support we’ve received from clinicians and investors in this regard has been expensive and is much appreciated. We will continue in our discussion with the FDA regarding ANCHOR as we move toward a planned type A meeting and the PDUFA data of December 20. Our goals are to successfully appeal the FDA decision and to be granted approval for the ANCHOR indication. We will continue to fight for what we believe is right. We believe in our product and we believe in our people we won’t let the results of AdCom standard growth of Vascepa in the MARINE indication and so we’re not going to ANCHOR this year or any time. In our new structure we are positioned well for the future and we will continue in our efforts to positively impact the lives of the patients with elevated triglycerides. With that I’d like to open the lines to some questions. Operator?

Operator

Operator

(Operator Instructions) Our first question comes from Jonathan Eckard of Citi. Please go ahead. Jonathan Eckard – Citigroup: Thank you very much. I just have a couple of questions. First one is, I believe there’s some new treatment guidelines expected to be released at AAH later this month. Are you aware of any items in these guidelines that could actually help support your position that you’re going with on with the FDA? And then the second question is regard the increase in the prescribers. So if I look at what you had end of the last quarter and what you have at the end of this quarter. You’re increasing prescribers significantly, I think it was up by about 45%. But the actual script per subscriber seems to be fairly steady and then it looks like almost like seven scripts per prescriber per quarter. Is there something that could accelerate the per subscriber usage of Vascepa going forward? Thank you very much.

Joseph Zakrzewski

Management

Yeah. Jon, this is Joe. Let me answer the second question first and then I’ll turn it over to Steve to answer the question about the treatment guidelines. I think what you seeing is natural and normal. As you hit the high prescriber audience earlier you’re getting those doctors write more and more scripts as you continue to grow you expand your base as we’re doing on the physician bases. But you may see "more constant number of amongst physicians". Having said that we think we think that the reorganization we put in place and the refocus on what I’ll call the high decile prescribers gives us an opportunity to shift that upwards, okay. So I think for the most part that’s pretty and not unexpected. John, do you want to add anything to that?

John Thero

Management

I guess there were a couple claims, to agree with all that. One is that we tend to be getting a lot of new patients starts with this and part of this is that we are a new drug, clinicians want to make sure it’s reimbursed, they want to have experience with it and that sort of leads into the second point which is that as they get experience and we getting continued feedback which is positive, we think that that experience is going to translate into increased prescriptions not only of the new starts, but increasingly up conversions from existing therapies as well. So, that’s all I wanted to ask.

Joseph Zakrzewski

Management

Okay. Steve, you want to take the first question?

Steven Ketchum

Management

Yes, certainly. So, Jonathan we will be in attendance at the upcoming AHA Sessions in Dallas. We’ve obviously seen the notification regarding the update on the guidelines. At present we’re not currently aware of anything specifically that may help our case beyond what we already hold against you are field documents to FDA. Jonathan Eckard – Citigroup: Okay. Thank you very much.

Operator

Operator

Thank you. The next question is from Bert Hazlett of ROTH. Please go ahead. Robert Hazlett – ROTH Capital: Thanks for taking the questions. I know it early days, have you had any change in trajectory or any dialogue with managed care regarding additional Tier 2 progress post the discussion with FDA. And then just to check in with regard to gross margins, I know you’ve given the target of high 70s to low 80s, again is that still hold given the consequences of the past several weeks? Thanks.

Joseph Zakrzewski

Management

Bert, hi. It’s Joe. Soon the Tier 2 progress I think the safest way to put it is, it continues on the same trajectory. We haven’t seen the trajectory change, so we’re very delighted and pleased about that. And what we’ve seen, again its only then three weeks, four weeks I think…

John Thero

Management

I think three weeks, seems like an eternity, but three weeks

Joseph Zakrzewski

Management

And the same point on the margins, we still expect to get there. You could – clearly, with the ANCHOR indication, you get there much faster. We’re not prepared to give guidance at this time, except to say you still get there. Because if you think about our other three suppliers, they are all operating, manufacturing, providing product that gets us close to that 79 to 80% margin. It’s the one supplier in Japan that has the higher cost of goods. So as we work that product through the system and bring the other suppliers online, we should still get there, albeit at maybe not as a fast of a rate as we’d like. Robert Hazlett – ROTH Capital: Okay. Thanks for the color.

Joseph Zakrzewski

Management

Thanks, Bert.

Operator

Operator

Thank you. The next question is from Thomas Wei of Jefferies. Please go ahead. Thomas Wei – Jefferies & Co.: Thanks. I was wondering if you could be any more granular on some of the breakdown of expenses. In particular, on the SG&A line, can you give us a sense of how much your base G&A expenses are versus the marketing spend for Vascepa outside of the sales force? And then a separate question – one strategy that’s come up and has been debated among the investment community has been whether or not you can suspend enrollment in REDUCE-IT temporarily. Is that a possibility that would somehow preserve the ultimate integrity of the trial? And I guess I wanted to understand from you – would that actually save very much money since the bulk of patients would still have to be in continuing follow-up? Thanks.

Joseph Zakrzewski

Management

Yeah. Let’s take these in reverse order, again. Let me make the quick comment, Thomas – this is Joe – on the REDUCE-IT. And then I’ll ask Steve to comment on that. And then, on the SG&A, I’ll turn it over to John. We’ve looked at that. We think the suspension is a problem on a couple of fronts. One is what is suspending a trial once you start to suspend you’ve lost all of your loyalty, okay. We also think suspending the study will put us in a very good situation going into the negotiations we’re about to have with FDA. So from a high business level, Steve?

Steven Ketchum

Management

Yeah, no they’re consistent with modules that in which we’ve spent a lot of time, energy and effort within the universe the existing universe up and running and building momentum. And obviously we have certain powering and other considerations for the trial that we don’t want to negatively impact unnecessarily.

Michael Farrell

Management

Regarding your question on SG&A we were to look at our trajectory through the times that was reported it was for this year about $130 million but we hadn’t made any reductions certainly in the fourth quarter. I think if you were to given the nature of what we’ve done in terms of reduction and which has been across the board. On the standing side I think it’s reasonable to assume that that level of expense reduction will be somewhat proportionate to the – due to the reduction in staff. So in terms of certain breakdown of core 15 sales, SG&A and marketing it’s roughly a third, a third, a third against that lower baseline in our medical activities involved in there as well. So hope those comments are helpful. Thomas Wei – Jefferies & Co.: Thanks that’s actually very helpful.

Operator

Operator

Thank you. That does conclude the question-and-answer session. I’ll now turn the floor back over to management for any closing remarks.

Joseph Zakrzewski

Management

Yeah. Again, I just wanted to reach out to everyone and thank everyone for their support under the current circumstances and I’m sure we’ll be talking to a number of folks in the coming days and we will be vigilant here and bringing this to what we hope is a very positive inclusion. Again, I can’t make any guarantees but we think we’ve got the right team in place and at the end of the day light is on our side. So thank you and have a good evening.

Operator

Operator

Thank you. Ladies and gentlemen, this does concludes today’s teleconference. You may disconnect your lines at this time and thank you for your participation.