Amarin Corporation PLC (AMRN) 2011 Q2 法說會逐字稿

Greetings and welcome to the Amarin second-quarter results conference call. (Operator Instructions). As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Steve Schultz, Director of Investor Relations for Amarin Corporation. Thank you, Mr. Schultz. You may begin.

Welcome and thank you for joining us today.

Before we comment on our financial and operating results, 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 results of our clinical trials and the potential efficacy and safety of our product candidates; the timing of our planned announcement and publication of these results; our current expectations regarding regulatory filings and potential indication for our product candidate, if approved; our current expectations regarding a cardiovascular outcomes study and the potential implications of any such study on our regulatory work process; the potential market opportunity for our product candidates; our current expectations regarding potential strategic collaborations; and our costs 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. And these include the risks and uncertainties under the heading risk factors in our most recent annual report on Form 10-K and our most recent quarterly report on Form 10-Q, and other periodic reports filed with the SEC, which reports are available on our website at AmarinCorp.com. They are also available on the SEC's website.

These forward-looking statements are only predictions. Actual results or plans may vary materially from those projected. The forward-looking statements we make on today's call are based on our beliefs and expectations as of today, August 10, 2011, only. We do not undertake any obligation to revise or update such forward-looking statements.

In addition, please note that the comments on this conference call regarding the efficacy, safety, and competitive positioning of AMR101 are made for consideration of investors and not to promote the use of AMR101, which is not approved for sale or use outside of approved clinical trials.

An archive of this call will be posted on the Amarin website in the investor relations section.

I'll now turn the call over to Joe Zakrzewski, Executive Chairman and Chief Executive Officer of Amarin.

Thank you, Steve, and welcome to everyone who is joining us today. During this call, we will provide you with a brief review of our recent accomplishments, give you an update on Amarin's financial performance in the second quarter of 2011, and review our corporate objectives as we move through the second half of 2011.

I am joined on today's call by John Thero, Amarin's President; and Paresh Soni, Senior Vice President and Head of Development; and Fred Ahlholm, Amarin's VP of Finance and Principal Accounting Officer.

Overall, we are pleased with the tremendous progress the Company has made over the last year. Since our last quarterly update, we achieved a number of key objectives, including completion of the ANCHOR trial, a pivotal Phase III study of AMR101 in patients with high triglycerides and mixed dyslipidemia in which all primary and secondary endpoints were achieved; completion of all other preclinical and clinical studies needed for our planned NDA filing this quarter; expansion and strengthening of our supply chain with the addition of new suppliers to supplement our existing suppliers; as announced today, secured a special protocol assessment agreement, or SPA, from the FDA for our cardiovascular outcomes study.

Grew our patent application estate with multiple additional patent applications filed based on positive, but unexpected, findings from the ANCHOR trial; received acceptance to present data from each of our two pivotal Phase III studies, the ANCHOR trial and the MARINE trial, in two separate podium presentations at the American Heart Association's scientific sessions 2011 in November; completed dosing of all patients in the 40-week extension period for the MARINE study; financially ended the second quarter with cash -- with a slight increase in cash compared with the first quarter; and added another experienced Board member with the election of David Feigal.

I will explain briefly some of these accomplishments, and then turn the discussion over to Paresh Soni to discuss our planned cardiovascular outcomes study and related SPA.

I note, however, that this is the third SPA for Amarin, which is remarkable. SPAs are not easy to obtain and not common for outcome studies. I commend Paresh and his team for both the SPA and, as he will discuss, constructing the cost of the trial such that we can afford to launch it promptly, both in support of the indications studied in the ANCHOR trial and in pursuit of an expanded indication for prevention of cardiovascular events.

We believe this expanded indication could position AMR101 towards our patient populations of more than 70 million in the U.S. alone, including the potential to more than double the market potential beyond the indications studied in the MARINE and ANCHOR trials.

We are very pleased to have all the preclinical and clinical work finished and we believe that we are well positioned to submit an NDA for AMR101 this quarter. We believe that the clinical and preclinical results of our studies of AMR101, the fact that our two pivotal Phase III studies were conducted under SPAs, and the overall safety profile of AMR101 position this cardiovascular drug candidate for approval following NDA review.

In both these pivotal trials, the primary endpoint of triglyceride reduction was achieved with very high statistical significance. Also demonstrated were significant reductions in secondary and exploratory endpoints for various lipid and inflammatory markers such as, Apo B, Lp-PLA2, VLDL-C and HSCRP.

Notably, these positive results were achieved without elevation of LDL-C, or bad cholesterol in patients and in the ANCHOR trial at the 4g dose [brought] a statistically significant 6.2% decrease in LDL-C on top of optimized statin therapy.

Current therapies are documented to increase LDL-C by about 40% to 50% in patients with very high triglycerides, and also has been shown to increase LDL-C in patients with high triglycerides on statin therapy.

We estimate that over 100 million people in the top markets of the world have triglyceride levels greater than 200mg per deciliter. In the U.S. alone, we estimate that approximately one in 50 adults have very high triglycerides and approximately one in five adults have high triglycerides.

Clinical treatment guidelines recommend that such patients be treated with diet and triglyceride-lowering therapy. Existing prescription omega-3 and fenofibrate therapies for lowering triglycerides sell over 2 billion annually in the U.S. alone. However, the market penetration is very low as it is estimated that they currently are used in less than 5% of the patients with triglyceride levels greater than 200mg per deciliter.

We believe that AMR101, due to its demonstrated product profile of reducing triglycerides, not increasing LDL-C, and excellent safety profile, will compete effectively with these kind of therapies and, more importantly, support market penetration and expansion well beyond current levels.

Both indications studied in the ANCHOR and MARINE trials represent potential multi-billion dollar opportunities with the possibility for future expansion into additional indications.

The NDA we plan to submit this quarter for AMR101 will include all data from both the ANCHOR and MARINE trials, as well as results of the other preclinical and clinical studies we conducted with AMR101. The initial NDA will formally request approval to market and sell AMR101 for the indications studied in the MARINE trial for patients with very high triglycerides, and we will seek to have the ANCHOR results referenced in the other clinical results section of the initial label.

Based on the success of the ANCHOR trial during Q2, we added two additional API suppliers and an additional encapsulation supplier. The new suppliers add diversity and cost competition to our supply chain. They also strengthen our ability to rapidly expand in order to support our commercial launch. It is important to note that we remain very pleased with the capabilities and performance of our existing suppliers.

We have received a heightened number of questions over the past couple of months regarding patent prosecution as we work to extend our patent position through 2030. Based on the positive and unexpected results of our MARINE and ANCHOR trials, we now have numerous patents in nine patent families filed and in various stages of prosecution with the U.S. Patent and Trademark Office.

We also have numerous patents in multiple patent families being pursued in other major markets. Because of the timing of the majority of these patent applications, which were filed after the MARINE trial which was -- that was complete late last year and after the ANCHOR trial completed in April, the U.S. PTO in the normal course of business is unlikely to respond to most of these applications this year.

On two of the patent applications, we received comments from the patent office and promptly responded to their comments. We will continue to prosecute these patents vigorously as we believe our arguments for patentability are sound.

Additionally, we received -- we recently announced that two oral presentations of AMR101 clinical results have been accepted for presentation at the annual meeting of the American Heart Association in November. One of these presentations, to be presented on November 16, will be the first presentation of ANCHOR trial results in a scientific forum. This abstract, delivered as part of a scientific session titled novel lipid-modifying therapies and other atheropreventive treatments, will be presented by Dr. Christie M. Ballantyne, principal investigator of the ANCHOR trial.

The other oral presentation, scheduled for November 15, will be on the MARINE trial results. Scheduled as part of a scientific session titled new frontiers in lipid management, it will be presented by Dr. Harold Bays, principal investigator of the MARINE study.

This presentation on MARINE trial results is anticipated to include information on particle size and related results not previously presented.

Before that, on August 29, clinical results of the MARINE study will be orally presented by Dr. Bays at the annual meeting of the European Society of Cardiology in Paris. Additionally in September, the American Journal of Cardiology is scheduled to publish the MARINE trial results.

We intend to remain active in seeking additional opportunities to present and publish our clinical trial results in the coming months.

I now ask Paresh, our Senior Vice President and head of Development, to discuss outcomes -- our outcomes study plans further with you.

Thank you, Joe. As announced earlier today, we are delighted to have reached a special protocol assessment agreement with the FDA for a cardiovascular outcome study.

This SPA was achieved after considerable input from our internal team, from multiple thought leaders, and various other interested parties. The trial design and SPA position us to move forward aggressively with the outcome study, not only in support of the indications studied in the ANCHOR trial, but also for pursuit of a potential label expansion for AMR101.

As many of you know, Amarin is planning to have a cardiovascular outcome study substantially underway, but not completed, in order to pursue the indications studied in the ANCHOR trial. No outcome study is required to be pursued for the indications studied in the MARINE trial. We refer to our outcome study as REDUCE-IT, which stands for reduction of cardiovascular events with EPA intervention trials. The trial is designed to assess whether AMR101 is able to reduce the residual cardiovascular risks that remain after statin therapy.

In REDUCE-IT, we will evaluate the effectiveness of AMR101 in reducing the first major cardiovascular event in an actual patient population. The control arm of the study will be patient on optimized statin therapy, and the active arm of the study will be patients on optimized statin therapy plus AMR101. All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease.

The study will be conducted in the U.S. and internationally. Amarin is responsible for the study. We will use an experienced CRO to help manage the study and we are in the late stages of contract negotiation with a leading CRO for that purpose.

We estimate that the study will require approximately 8,000 patients and involve several hundred clinical sites. We also estimate that the study will require approximately six years for completion with outcome study activity anticipated to commence in 2011 with our goal of achieving approximately 50% enrollment sometime during 2012.

Based on quotes from CROs, we anticipate the cost to conduct REDUCE-it to be approximately $100 million to $125 million over a six-year period with less than $25 million to be paid before the end of 2012. It is also important to note that getting started with the outcome study is completely manageable within our current budget as the cost of this study will be distributed over the duration of the study.

Upon completion of the outcome study and assuming a successful result, we anticipate being able to pursue a cardiovascular event prevention label, the potential population for which is considerably larger than the population for the indications studied in the ANCHOR and MARINE trials.

We also anticipate that, similar to ANCHOR, a significant number of patients in the study will have diabetes mellitus. Even beyond control of LDL cholesterol with statin, there is a high unmet medical need for the reduction of cardiovascular risk in this patient population.

We look forward to getting REDUCE-IT underway, and it will become our priority as soon as the NDA is submitted.

Separately, Joe mentioned the 40-week extension to the MARINE study that has completed dosing. I want to remind you that the data from that optional extension phase of the MARINE study is not required for the NDA submission. Once we receive and evaluate the data from the study extension, we will provide an update on the results. We anticipate that the study will confirm that AMR101 lowered triglyceride levels beyond the 12-week study period of the MARINE trial.

I now ask Fred Ahlholm, Amarin's Vice President of Finance, to comment on Amarin's second-quarter 2011 financial results. Fred.

Thank you, Paresh.

Yesterday, Amarin filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2011, Amarin's second quarter. While I'll provide some comments here regarding our financial results, you will find a more detailed discussion of our results in our 10-Q as filed with the SEC.

Amarin's cash and cash equivalents as of June 30, 2011, totaled $131.4 million. This cash balance is up from $129.5 million at March 31, 2011. This increase in the Company's cash and cash equivalents resulted from the proceeds from warrant and option exercises, partially offset by payments for operating activities.

In Q2, approximately $8.5 million was received from warrant exercises, resulting in the issuance of 5.8 million American Depositary Shares, ADSs, where each ADS represents one ordinary share.

Also in Q2, proceeds of approximately $3.2 million were received from the exercise of stock options for 1.2 million shares or ADSs. Amarin had approximately 133 million ADSs and an additional 378,000 shares outstanding at June 30, 2011. In addition, the Company has stock options outstanding for the purchase of 10.2 million ADSs and warrants outstanding for the purchase of 23.7 million ADSs.

For the three months ended June 30, 2011, the Company's total operating expenses were $15.2 million, compared to $10.6 million in the same period of the prior year. The increase is due primarily to non-cash charges for compensation expense related to warrants and options. Excluding non-cash costs associated with warrants and options, operating expenses were $8.4 million in Q2 2011, compared to $9.2 million in the same quarter of last year.

The largest single line item on the Company's operating statement is a non-cash loss from the change in fair value of warrant derivative liability. In conjunction with the private placement of ADSs completed in October 2009, the Company issued warrants that contained a pricing variability feature whereby the exercise price of the warrants could increase if the exchange rate between the U.S. dollar and the British pound changes we find it -- beyond a defined threshold.

Although the number of shares eligible to be issued under the warrant does not change under any circumstance, in accordance with U.S. GAAP this pricing variability feature requires the warrants to be classified for accounting purposes as a derivative liability. The fair value of this derivative liability is re-measured each reporting period with changes in the fair value recognized in Amarin's results of operations.

This warrant derivative liability represents a non-cash item. Upon exercise of the underlying warrant, the fair value of the warrants exercised is reclassified from liabilities to equity.

As of June 30, 2011, the warrant derivative liability was $286 million, a net increase of $111.2 million from March 31, 2011. This increase in the fair value of the warrant derivative liability was due primarily to the increase in the market price of our ADSs since March 31, 2011. The closing price of our ADSs has a significant impact on the value of the derivative liability, and therefore the value of the derivative liability can shift significantly from quarter to quarter.

Again, I would like to reiterate that the warrant derivative liability and the corresponding change in value of the warrant derivative are non-cash items.

During the quarter ended June 30, 2011, the Company reported a loss from the change in value of the warrant derivative liability of 184 -- $185.4 million versus a loss of $29.9 million in the prior-year period. As a result, during the quarter ended June 30, 2011, the Company reported a total net loss of $202.1 million, or $1.58 per share, both basic and diluted, versus a net loss of $41.4 million, or $0.42 per share, both basic and diluted, in the prior-year period.

Excluding the warrant derivative liability, the Company's reported liabilities as of June 30, 2011, totaled approximately $4.3 million.

As of June 30, 2011, we estimate that we have approximately $3 million remaining to pay to our CRO in connection with the completion of the ANCHOR and MARINE trials, including the 40-week extension period for the MARINE trial. This remaining amount will be paid this year and represents a significant reduction in R&D spending associated with these clinical studies.

Offsetting this reduction in R&D spending for these clinical studies will be spending in connection with the new REDUCE-IT outcomes study. We will likely incur some modest staffing and other internal R&D costs to support the CRO and the conduct of this outcomes study.

In addition to these R&D costs, we expect to continue to incur costs to support our third-party suppliers, including inventory purchases and other payments which we outlined in connection with entering into those supply agreements.

Our marketing, selling, and general expenses for Q2 were approximately $3.4 million, excluding non-cash costs associated with stock and warrant-based compensation. We anticipate that these costs will increase during the balance of 2011 as we expand our market preparation activity and take other steps to support multiple potential paths to the commercialization of AMR101.

That concludes my prepared comments, and I would like to hand the call back to Joe Zakrzewski. Joe?

Thanks, Fred.

We believe that AMR101 is well positioned to be a catalyst in an emerging paradigm shift that has started toward broad lipid management, as cholesterol management alone is not enough.

We believe there is a large unmet need for new therapies that target the broader set of lipids, including triglycerides, and that AMR101 has the potential to redefine lipid management therapy.

Our objectives for the remainder of 2011 include submission of an NDA for AMR101 by the end of September; presentation of further results in both MARINE and ANCHOR studies, including the 40-week MARINE extension study; complete contractual negotiations with our CRO on the outcomes study and take other steps to begin initiating clinical studies for the REDUCE-IT cardiovascular outcomes study; continue progress with preparation for commercialization of AMR101, on our own or with a strategic partner.

Thank you for your interest in Amarin. I would now like to open the call for questions.

(Operator Instructions). Bill Tanner, Lazard Capital Markets.

Thanks for taking the question. Maybe a couple of them for Paresh. I'm wondering if you could provide any more detail on the outcomes trial, specifically entry criteria related to triglycerides or other risk factors, and if you could comment on how you sort of thread the needle, I guess, in terms of having a trial that is broadly applicable to the population, but also having a successful trial?

And then, any comment on what substantially underway means, and is it possible to hit whatever that percentage enrollment is sometime around the end of the MARINE review? Thanks very much.

Paresh, you want to take that?

Sure, I'll take that, Joe. Hi, Bill. Thanks for your questions.

Just to let you know that we do intend to publish the full protocol for the outcomes study sometime next year, after we have started enrollment and we are well on our way with enrolling patients into the study.

We have tried to [enrich] the study as much as possible with risk factors, and we have patients in the study that have either had a previous event like a stroke or an MI, or have documented cardiovascular disease based on angiographies or (technical difficulties). So it's quite a high-risk population.

We are also looking at diabetic patients with at least one other risk factor in addition to having diabetes and an elevated triglyceride level.

We selected patients with triglycerides above 150mg per deciliter, and that gives us quite an [enriched] population for a high-event rate. And that is why we think that the study is likely to be successful in terms of giving us event rates and being able to demonstrate the efficacy of the drug in that population.

In terms of what we think is substantially underway, the most conservative definition we've used is approximately 50% enrollment that we need to have underway by the time we submit the ANCHOR (technical difficulties) the indication for [mixed] dyslipidemia, which comes off the ANCHOR study, efficacy and safety data, and we think that from the time we start the study, it will be roughly three to four quarters by the time we reach what is about 50% enrollment. That is our current projection.

And then, we're going to work on more details for the CRO as we get into more details of the study.

But is that 50%, is that in the predefined substantially underway agreement with the FDA, or I know you guys have talked consistently about it being conservative. Possible that substantially underway, the definition thereof, is something less?

I would say we don't know the official answer to that. I think Paresh's point is the most conservative approach is the 50%. We're hoping it is less than that.

And to your other question, we also hope that as we submit all the data in September, by the time we actually have the so-quote substantial enrollment, the FDA will be impacted positively to say, ah, you have met the criteria. We'll give you both indications simultaneously.

Again, there can be no guarantee of that, but that is our goal. Submit all the data, enroll as fast as possible, gain the FDA's trust. They have helped us design the study. This is our third SPA, and then, hopefully, simultaneously get both indications approved.

Perfect. Thanks very much.

Joseph Schwartz, Leerink Swann.

Good morning and congratulations on the continued progress. I was wondering if you could talk about some of your powering assumptions, Paresh? How do you get to these sample-size estimates? What kind of a background event rate do you assume? And improvement events, where do you think these events will be racked up? And separation generated.

It strikes me that the effect size would have to be pretty significant on such a small number of patients on optimized background therapy. So if you could address any of those issues, that would be appreciated.

Paresh.

Sure. Again, we intend to publish all this information when we publish the third part next year.

We have looked at several studies that have been conducted especially in the recent past that use the same endpoints as we do in our study. We have a composite end point that has different components to it, and we look at the event rate for each of the components and use the power calculations based on that. And we looked at that and applied that to the placebo group.

We're looking for about a 15% reduction from that event rate in the placebo group. So we're looking for a delta of about 15%.

And the composite endpoint is quite a broad endpoint, so we are expecting quite a high event rate. We haven't -- we've gotten broader-than-typical outcome studies, and again, we'll be publishing details of that.

Great.

Hey, Joe, just one other point there. Remember that the outcomes study that was done in Japan with the 18,650 patients, and we're doing 8,000, but of that 18,650 patients, only 1,000 had triglycerides over 150. So we're going to have 8,000 patients over 150. So that may be also part of the reconciliation there as well.

Right, and I remember they had a much higher event rate reduction. Isn't that correct?

Yes. 53% in that sub-population with a high triglyceride and low HDL. So, remember, the [Jella] study was pretty much a low-risk population. We're studying a high-risk population, and a Western population typically has greater events, more events than a Japanese population. And also, the Japanese population have high background EPA levels because of their high dietary fish intake.

In addition, the Jella study had lots of patients with primary prevention, whereas we are looking at mainly a higher-risk population, most of whom will have secondary prevention.

And then as a follow-up, what kind of interim looks do you expect to take, and how you ensure that the SBA doesn't unduly impact your ability to be flexible if you learn anything underway and need to increase size or anything like that?

Paresh.

So we are taking one interim look for -- to see if we achieve superiority.

And that's -- after a certain number of events have been observed, we'll take a look. With that built into the protocol and the FDA has approved that, because it doesn't affect the specific -- it's a very small effect. It doesn't really change our powering assumptions a lot. We've built that in.

So, in terms of the power calculation, we actually do the event rate using one patient level database and multiple publications. And then, we actually came to a smaller number than the current 8,000, and we bumped it up to 8,000.

So we think we're pretty good for the -- even if the event rate is lower than what we projected, we should still have a buffer in there that will give us enough events to complete the study.

As a last-course resort, of course, some outcomes studies do end up extending the duration of observation if they don't have enough events. That's still an option open to us. So we're hoping, of course, we don't end up having to do that. We could extend the observation period by an extra six months or so, if we needed to.

Great. Thank you.

Thomas Wei, Jefferies & Company.

Just wanted to drill down a little bit more on the last question. What is the annual event rate that you're expecting in the control arm?

Paresh?

Again, understand, we will be publishing that information, Thomas, and we will provide more details of how we came to that when we publish the paper on that.

And it is quite common today to publish the protocols to outcomes studies because we have to -- it basically -- it's a designed publication, and we will explain how we did that.

We think we have a very good event rate [listing]. Very much the event rate is also related to the risk of the population and the composite endpoint, and we've chosen quite a broad composite endpoint and a very high-risk population.

And in the SPA process, how many rounds did you go through with the FDA, and what were some of the points of contention or are there major revisions that the FDA wanted you to incorporate into the trial design?

Actually, we only needed to do two rounds, and after the first round most of the comments from the FDA were very supportive and more giving us guidance rather than objecting to anything.

For example, they didn't want us to use the highest dose of simvastatins. They wanted us to do the study more globally and make sure that we include Western and non-Western countries.

You know, they wanted us to use the same -- the same three statins that we used in the ANCHOR study, and we argued that it shouldn't matter for the outcomes study. As long as the patients are at goal for LDL, it doesn't matter what statin they are on.

So in fact, there were only two rounds, and we had one [telefon] in between to discuss all the outstanding comments, and when we finally submitted the protocol for an agreement, they accepted it as is because we had agreed on everything in advance prior to that.

And Tom, don't forget the other benefit we had was because of the great work of Paresh and his team on the first two SPAs. By the time we got to the third SPA, and again, these things are fairly uncommon, I think there was a very strong collaborative approach here, and my hat is off to Paresh and his team for that.

And maybe just two quick ones. The geographic mix, as long as you've mentioned that that was one of the things that the FDA was looking for. What should we think is where this trial is going to enroll, and then, also -- well, maybe I'll just leave it at that.

In terms of the geographic mix, what we've agreed to do is we'll have about half the patients enrolled in the U.S. and countries with similar standards of care as the U.S.

And we've defined that as countries in western Europe, North America, Australia, South Africa. And then the other 50% will come from non-western countries, including countries in eastern Europe, maybe India. And we're still going to work out the details as to exactly which countries to go to.

But roughly 50%, we have told the FDA, will be Western countries and countries of similar standards of care. And they were very comfortable with that.

Thanks.

Ritu Baral, Canaccord.

Thanks for taking the question. Can I ask what sort of background meds you are allowing or not allowing in the outcomes trial? And that would include diabetes meds as well.

Paresh?

Sure. Hi, Ritu. Generally, we are allowing, obviously, statins. Everybody has to be on a statin and at LDL [goal].

In addition to that, as long as the background therapies are stable, they can be on any diabetic therapy and the diabetes needs to be controlled.

The ones that we are not allowing specifically are things like fibrate therapy, [Niaspan] and any other omega-3, above a very small dose of about 200 mg per day. Everything else is allowed.

We're trying to make this as real world a study as possible and not to have -- apply too many restrictions. Obviously, we cannot have other drugs that significantly lower triglycerides. So those are our exclusion criteria.

But we want [these] patients with diabetes to be on their background meds with whatever they are taking, whether it's insulin or metformin or, for example, [ligitizone], and we anticipate there will be a large number of diabetics in the study because it's a similar population to ANCHOR where we had 73% of the population had diabetes, and really it wouldn't surprise me if it ends up being an outcomes study in patients with diabetic dyslipidemia.

So, we have been quite broad with that. Only a few drugs are excluded. As long as they are on stable and -- a chronic set of (inaudible) stable dose before the trial and during the trial.

Great. And could you go over what remaining activities you have planned for 2011 as far as getting the outcomes study up and going? Do you plan on having all the sites up within a certain quarter, screening patients, enrolling patients within a certain quarter at this point?

And also, if you could just briefly touch on any hard timelines you have for some of the patents in prosecution, whether they're response deadlines by the PTO or response deadlines on Amarin's part?

Yes, let me start there and we can go, if we need to, deeper.

On the patents, we have got a number of families. I think we filed an additional nine families on the results of ANCHOR and on MARINE. Again, most of those we'll hear from the agency probably next year, from the patent agency.

We have been in dialogue on two patents with them this year so far. And we expect that -- to have further news by the end of the year on those two.

Regarding where we are at with the outcomes, we are still in the heat and the throes of the design, but again we're in the commencement mode as we speak, and we really intend to be heavily into that between now and the end of the year, the final five months.

In terms of real specifics, I don't think we're prepared to give any of those now, except to say that we expect to be 50% enrolled before the end of 2012.

Great. Thanks for taking the question, guys.

I'll now turn the conference back over to management for closing remarks.

Well, look, this is Joe Zakrzewski again. Again, it has been another great quarter for the Company. We continue to progress and execute with a sense of urgency, and again we thank everyone for their interest in our Company and in this potentially revolutionary drug that we're developing. So thank you and good day, on behalf of our team.

Thank you. This concludes today's conference. All parties may now disconnect, and have a great day.