Amarin Corporation PLC (AMRN) 2010 Q2 法說會逐字稿

Greetings and welcome to the Amarin Corporation PLC second-quarter fiscal 2010 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, John Thero, CFO for Amarin Corporation PLC. Thank you, Mr. Thero, you may now begin.

Thank you, operator. Welcome to Amarin Corporation's second-quarter 2010 conference call. With me today is Dr. Declan Doogan, interim Chief Executive Officer. In a moment, I will turn the call over to Declan for an update on our clinical trial progress. After that, I will discuss our second-quarter 2010 financial results. Then we'll open the call to your questions.

Before getting into these discussions, I remind everyone that today's call will include statements that are not historical and may be characterized as forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing and results of our clinical trials, the anticipated timing of regulatory filings, and the adequacy of our financial resources.

These statements involve various risks and uncertainties that could cause our actual results to differ materially from those expressed in such forward-looking statements. These include the risks and uncertainties under the heading risk factors in our most recent annual report on Form 20F and other periodic reports filed with the SEC. Such reports are available on our website at www.AmarinCorp.com. They're also available on the SEC's website.

These forward-looking statements are only predictions and actual results or plans may vary materially from those projected. The forward-looking statements we make on today's call are based upon our beliefs and expectations as of today, August 10, 2010 only. We do not undertake an obligation to revise or update such forward-looking statements.

With that said, I now turn the call over to Declan.

Thank you, John. I, too, welcome everyone to today's call. The highlights of today's press release is that we believe that Amarin is within six months of being able to review and report results of the MARINE study. As you likely read in our two press releases from earlier today, Amarin has made important progress in the two Phase III clinical trials known as MARINE and ANCHOR we are running with our lead product, AMR101, for lowering elevated triglyceride levels in patients.

In the MARINE trial, we have completed patients enrollment in randomization into the 12-week treatment phase of the trial. In the larger ANCHOR trial, we have completed more than half of the targeted patient enrollment in randomization. For both trials we anticipate reporting the results in 2011 with topline results for the MARINE trial expected in early 2011. This guidance for the timing of MARINE results was updated today and is towards the front end of the guidance range we provided previously.

You may recall that we began this year projecting clinical results in 2012, so this is tremendous progress.

As discussed last quarter, we believe that the clinical program with AMR101 has a good chance of success based on historical clinical work gathered over many years and in many patients that suggest that ethyl-EPA over 96% pure, the primary component of AMR101, is both safe and effective in lowering triglyceride levels.

Lowering triglyceride levels as we believe is evidenced in the historical works such as the 18,000 JELIS study can lead to a reduction in cardiovascular events. In addition, the protocols for both studies have been agreed with the FDA in the form of special protocol assessments in the context of agreements made at the end Phase II meeting.

I am very encouraged by the progress that Amarin has made in advancing the project since fourth quarter last year, when we received financing to fully undertake our clinical programs. Since that time, we have initiated two Phase III trials, completed patient enrollment in randomization in one, and completed more than half of the patient enrollment in randomization in the other. I have great faith in the team and look forward to continuing to update you on our progress as we move forward.

Just briefly, for anyone on the call who is new to Amarin, AMR101 is a prescription grade semi-synthetic form of eicosapentaenoic acid, ethyl-EPA and omega-3 compound and it is being developed so that it can be positioned as a best in class prescription medicine for treating patients with elevated triglyceride level. It is a single active moiety with an excellent safety profile and strong scientific and clinical evidence supporting its efficacy in lowering triglyceride levels.

Elevated triglyceride levels have increasingly been recognized as a significant modifiable risk factor for cardiovascular disease along side LDL-cholesterol. As you have heard already today, AMR101 is in two Phase III clinical trials. The MARINE study evaluates the safety and effectiveness of AMR101 in patients with very high triglycerides, over 500 milligrams per deciliter. Essentially, we believe this trial can support a label similar to GSK's billion-dollar drug, LOVAZA.

The ANCHOR study evaluates the safety and effectiveness of AMR101 in patients with mixed dyslipidemia, that is high triglyceride levels of 200 to 500 milligrams per deciliter who are also on statin therapy.

In the US, no prescription omega-3 product is currently approved for this patient population. There are approximately 10 times more patients with triglyceride levels between 200 and 500 milligrams per deciliter than there are patients with very high triglyceride levels, the market for which LOVAZA is approved.

We believe AMR101 is a potential best in class prescription omega-3 with multiple potential advantages over LOVAZA in that. One such potential advantage is that AMR101 has no DHA. Studies have shown that DHA can contribute to elevations in LDL-cholesterol, the so-called bad cholesterol.

To the extent we can show an absence of an effect on LDL-C, particularly in patients with mixed dyslipidemia on background statin therapy, this could provide an important differentiation between AMR101 and its competition. Other potential advantages of AMR101 include lower pill burden and lack of fishy smell or taste.

In the MARINE study, we enrolled and randomized 229 patients, making this to our knowledge the largest controlled clinical trial ever conducted in this patient population and the first such study conducted in the post-statin era. The MARINE study is a global multicenter placebo-controlled randomized double-blind 12-week study and it is designed to evaluate the efficacy and safety of both 2 grams and 4 gram doses of AMR101 compared with placebo with the primary endpoint being reduction in triglycerides from baseline.

The ANCHOR study is targeting randomization of 650 patients. This too is a multicenter placebo controlled randomized double-blind 12-week study evaluating in a separate patient population the efficacy and safety of 2 gram and 4 gram doses of AMR101 compared to placebo. In both trials, all patients undergo a six- to eight-week washout period. Upon completing this period, patients who qualify for treatment are randomized to the 12-week double-blind treatment phase.

The pace at which MARINE and ANCHOR trials have moved is a tribute to everyone involved in the trials including the clinical sites, our CRO, and our very experienced development team at Amarin. The speed of recruitment in these two studies also reflects the growing interest among the medical community in treating elevated triglycerides. Although there can be no assurance that these enrollments and randomization rates will continue, we are encouraged by our experiences to date in these trials.

We look forward to summarizing the results of these trials in the future and assuming positive results, we anticipate filing an NDA for AMR101 in 2012. 2012 may seem like a long way off, but behind the scenes we are actually preparing for the NDA submission.

Our development group led by Dr. Paresh Soni not only has significant experience in overseeing clinical trials but also has significant experience in leading drugs through the approval process. This experience was evident when Amarin successfully secured SPAs with the FDA for both MARINE and ANCHOR trials. I am confident that with this experience and Dr. Soni's leadership, we will be ready for a robust and timely NDA filing for AMR101, assuming our Phase III results turn out as expected.

As we have previously stated, while we could commercialize the AMR101 ourselves, the profile of this drug makes it an excellent candidate for partnering. We continue to receive considerable interest from a number of global pharmaceutical companies and with the continued advancement of the Phase III trials, we look forward with enthusiasm to continued advancement in this area.

On that note, let me now pass the call back to John to provide an update on the Company's financial position as of June 30.

Thank you, Declan. Amarin's cash balance as of June 30, 2010 was approximately $37.6 million. The Company reiterates its guidance that its current financial resources are sufficient to finance planned operations through the completion of the ongoing MARINE and ANCHOR Phase III clinical trials through the reporting of results for these trials, and assuming clinical success, through submitting an NDA for AMR101.

During the three months ended June 30, 2010, net cash outflows were approximately $6.8 million, including approximately $5.3 million paid in connection with the Company's two Phase III clinical trials. These clinical trial costs include costs related to patient recruitment, enrollment, randomization, and treatment for both the MARINE and ANCHOR trials. With patient enrollment and randomization now complete for the MARINE trial, we anticipate lower spending for MARINE in the second half of this year.

The Company's cash outflows during the quarter were partially offset by approximately $1.5 million of net proceeds received from the exercise of warrants. The warrants were exercised by three investors, the exercises, at prices ranging from $1 to $1.50 per share resulted in the issuance of approximately one million shares during the quarter ended June 30, 2010, increasing the number of shares outstanding to approximately 99.8 million shares.

As of the same date, June 30, 2010, in addition to the shares outstanding, we had 40.2 million warrants outstanding at an average price of $1.76 per share and 8.8 million stock options outstanding at an average price of $2.44 per share.

I now turn the call back to Declan for a summary and questions.

Thank you, John. As I hope you have heard today, we are very pleased with the progress we've made with our Phase III trials. We look forward to reporting results of these trials beginning with the results of the MARINE study, which we currently expect to report early 2011. We at Amarin continue to look forward to the remainder of 2010 with great confidence.

Thank you for your attention today and now I would like to open the call to questions. Operator?

(Operator Instructions) Joseph Schwartz, Leerink Swann.

Good morning and congratulations on all the progress. I understand there is a non-inferiority band of plus or minus 3% in the ANCHOR study for LDL, so these patients have mixed dyslipidemia. What would you expect LDL to do for patients on drug in the MARINE study? Would lowering triglycerides dramatically be expected to result in an increase in LDL?

Joe, thank you for your question. We have designed this program predicated on the notion first of all that pure EPA is sufficient to not only bring down triglycerides but also that translates into presumed benefit for cardiovascular outcomes.

In the process of designing the program, it became apparent that DHA is -- has got real propensity to elevate LDL cholesterol. Now when we looked also under literature for EPA and similar kinds of studies, we could not find that same propensity to elevate. Now, I think it's possible when patients with baseline triglyceride levels of greater than 500 milligrams per deciliter are treated who are not on statins, there may be the possibility of an elevation of LDL.

But on the other hand, we don't know the results yet of this study and there is insufficient data in the literature in this 500 milligram cohort to be able to definitively answer that. But it's a very reasonable question and it is one of the aspects of the MARINE results that will be intriguing.

Great, thank you. I will get back in the queue.

So one other point to make is that the actual study that was conducted to address LDL is on statin therapy the ANCHOR study. What we were trying to show is that you do not get an elevation of greater than 6% in LDL cholesterol in part of the patient population, not 3%.

Duane Nash, Wedbush Securities.

Good morning and thanks for taking the questions. Can you say when you completed randomization in the MARINE study? I would roughly calculate first half of July. Any comments?

No, no, it's only just recently in the last while we have completed it, not that early.

Okay. And any updates on potential partnering of AMR101?

John, would you like to answer that?

We are active in discussion with partners but as you know, the completion of partnership is something that's not totally within our control. So we've not in the past given guidance on timing of partners. We have said in the past that discussions are active and we believe that they continue to be active. Certainly with today's press release and the progress we've made towards getting through the MARINE study and the ANCHOR study, we think we will be positive towards those discussions. But we cannot and have not provided guidance relative to the timing of a partnering.

Understood, thanks very much.

Ritu Baral, Canaccord Adams.

Thanks for taking the question. Have you guys seen any shift in the paradigm for treating high triglycerides in recent months and quarters as the sort of ACORD data filters out and the safety profile of fibrates I guess spreads?

Thank you for your question, Ritu. Well, clearly with the report of the ACORD study, which for those on the call who don't know this, it basically failed to meet the primary endpoint of showing reduction in risk factor modification with fenofibrate. This added to the previous field study does call into question exactly what the risk factor modification that fibrates bring is now current.

Certainly within the academic community and some prescribers that I've spoken with, it is clear that these two studies are starting to elicit some concerns. As for an impact in prescribing patterns at this point, I couldn't quite say, but certainly it is a very dynamic area and one that with the introduction of new therapies that do modify triglycerides without some of these issues, I think it affords a great opportunity.

Great, and one quick follow-up question. Has there been any elucidation as to the role of small dense LDLs and how those levels are changed with omega-3 treatment reverses fibrates?

So there has been quite a lot of literature at a mechanistic level suggesting a shift between small and large dense particles. My view on this is that there is a lot of work to be done to validate that particular position and to show that that shift indeed is not associated with increased risk. So I think it will be a long time before that is indeed established.

Great, thanks. I'll hop back in the queue.

Joseph Schwartz, Leerink Swann.

Thanks for taking the follow-up. I was wondering how you are doing in terms of identifying potential sources of additional drug supply?

I will ask John to answer that on my behalf.

As you know, we have a supplier that we have been using for quite a while. It's a company that was providing drug product to us during the Huntington's disease clinical trials and has continued to provide us a drug product currently. They have (inaudible) on file in both the US and the EU and they are very committed to and would like to provide us all to supply that we need.

At the same time, we think it prudent to have alternative suppliers and we have identified suppliers that we think are capable of being alternative suppliers for us and we are in discussions with those suppliers regarding price, quantity, those types of things.

So it's a bit of the competitive process and it's currently moving along just fine, but until we actually have completed agreements, I don't have anything specific to announce other than that we think it's going along fine.

Great, thanks for the update.

Ian Hunter, Goodbody Stockbrokers.

Good afternoon, gentlemen. Most of my questions have been answered already, but maybe just a quick thought you have. Are you doing any concurrent work on educating the potential markets on the benefits of AMR001 given what's going on in the market at the moment? It's already been alluded to in earlier questions.

Thank you, Ian. I think what we're doing just now is that we are concentrating on executing the Phase III program. We are a small company. We have got 16 people here and we have the support of a CRO to deliver the program.

We do have a scientific advisory board that we use to guide us on the robustness of our positioning and also the scientific position that we have established. I think it's fair to say that in the course of the past year with our investigations of the relative roles of EPA and DHA, it has posed some very interesting situations for academic opinion leaders to ponder.

As for general market education, it is premature at this point and when we then start to prepare the market for the launch of the product, that's when these sort of aspects will be further promulgated.

That's great, thanks very much.

A follow-up from Ritu Baral, Canaccord Adams.

Thanks for taking the follow-up. Can you remind us again if there are any interim DSMB looks either in ANCHOR or MARINE? And if they look at LDL levels or any other sort of cardiovascular biomarkers?

Ritu, no, there are no interim looks. We've agreed just a single analysis at the end of the study and the study is powered appropriate for that and not for interim looks.

As for DSMB safety looks, we also have tremendous vigilance over the safety of the patients in these two studies. We have a safety committee reviewing on a blinded basis any of the adverse events that have been identified. And I am pleased to say that the profile of the blinded medications are very satisfactory.

That's great to hear. You guys are probably sick of me asking this, but any additional clarity or viewpoints or thoughts that you might have on the outcome study that will be initiated once you pursue the 200 to 500 triglyceride filing?

Our position on this, Ritu, is that the outcome study is a component of the program that has been agreed with the FDA and the obligation is that the program be started before the submission of the NDA. At this point in time, we are in the design phase and as you can understand, this is a pretty complex project and we have been securing input from many global lead -- key opinion leaders in cardiovascular epidemiology. And so the protocol is not finalized, but we are progressing that.

Will the data from MARINE help inform the outcome study?

Yes, of course.

Will you need the ANCHOR data to help inform that as well?

I think what we would say is that whatever data are emergent at the time will be used. I can't say that we would wait for ANCHOR data before finalizing the protocol, but it really just depends on the relative timing. But what I can say is that the MARINE data should be an important piece of information before finalizing the protocol.

Great, thanks for taking my questions.

Lee Howard, The Day Publishing Company.

Yes, thanks. Declan, I was just wondering -- maybe I missed this, I came in a little bit late. But are you all proceeding in your efforts to switch over to the US stock market and provide more financial data?

Thank you, Lee. I will ask John Thero to answer that.

So I believe what you are referring to not so much the switching to the stock market, but rather reporting under US GAAP and under forms that would be more analogous to a domestic filer in the US. And we are working down that path. It's a bit of a nontraditional path as we found out with our discussion with regulatory authorities of trying to switch midyear. Those regulatory authorities have viewed it as sort of an intriguing question. And we are trying to figure out how we can do that on a voluntary basis as soon as possible -- if -- without having filed a 10-K for last year, which is typically the basis for that sort of quarterly filing.

So if we're not able to file a report because of regulations this year, we will find ways to increase the level of information that we report. But we are working through that at this point in time and it is our commitment to continue to provide broader information.

Okay, and you will not become a fully American company until that process is completed?

We have -- substantially our operation is in the states right now. Having said that, our intellectual property is in Ireland and we are planning to remain incorporated in Europe and certain of those assets and other aspects of our operations will remain over there. But our core development team and the majority of our corporate activities are here in the states.

Okay, thank you.

Thank you. There are no further questions at this time. I would now like to turn the floor back to management for closing comments.

I would just like to say to everyone, thanks very much for joining this call. We appreciate your continued interest and support of Amarin as we continue into the late phase of the Phase III program and wait with anticipation on the results of the studies. Thank you very much indeed.

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