Amarin Corporation PLC (AMRN) 2010 Q3 法說會逐字稿

Greetings. And welcome to the Amarin Corporation third quarter fiscal 2010 conference call. (Operator Instructions). It is now my pleasure to introduce your host, Mr. Joe Zakrzewski, Chairman and Chief Executive Officer. Thank you. Mr. Zakrzewski, you may now begin.

Thank you Rob. Good morning, good afternoon, good day to everyone and welcome to Amarin's third quarter 2010 conference call. I'm delighted to be here as Chairman and in my new role as CEO and to have been a part of Amarin for over a year now. The progress here has been tremendous, as you have read some of the updates from the press releases today. And I look forward to playing an even broader role in advancing Amarin as a Chief Executive. With me today are John Thero, the Company's new President, and Dr. Declan Doogan our Chief Medical Officer.

As an agenda for today, after some legal comments that I will turn the call over to John for in a minute, I would like to cover three broad topics. One, the clinical trial update that I will ask Dr. Doogan to cover. Number two, comments on my role and the Executive changes at the Company that I will cover and number three, comments from John Thero on our financial status and Q3 results. We will then open the call to questions. With that let me turn it over to John for the appropriate disclaimers.

Hi, everyone, I, too, welcome you to today's call. I remind everyone that today's call will include statements that are not historical and need to 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 timing of our planned announcement and publication of these results, our current expectations regarding regulatory filings and the potential indications of our product candidates if approved, the potential market opportunity for our product candidates, our current expectations regarding potential strategic operations, and the adequacy of our financial resources. These statements involve risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements and these risks include risks and uncertainties described under the heading Risk Factors in our most current annual report on form 20 F and our other periodic filings with the SEC which filings are available on our website at www.amarincorp.com. They are also, of course, available on the SEC's website.

These forward-looking statements are only predictive of actual results and plans may vary materially from these projections. Forward-looking statements are made only as of today's date and are based our belief and expectations as of today, November 10, 2010. We do not undertake any obligation to revise or update these forward-looking statements. Now, following the outline that Joe has provided, let me turn things over to Declan for a clinical update.

Thank you, John. I'm delighted to speak with everyone today as we continue to make tremendous progress in our Phase III trials. As highlighted in today's press release before 2010 is over we expect to reach two key milestones,one for each of our two Phase III clinical trials known as MARINE and ANCHOR.

Under separate Special Protocol Assessment agreements with the FDA these two pivotal Phase III trials are being conducted to evaluate our lead product AMR101 for lowering elevated triglycerides for two separate indications. In the MARINE trial, the patient treatment phase is nearing completion, and we now expect to report top line results before the end of 2010, ahead of previously stated guidance of such a report in early 2011. The clinical sites in this trial worked (inaudible) diligently and we believe we will be able to collect all necessary data and evaluate the data faster than previously expected.

In the ANCHOR trial we have now screened a sufficient number of patients to complete the trial. Furthermore, while most of the patients screened have been randomized through the twelve week double blind treatment period, we have a substantial number of additional patients screened and progressing through the six to eight week run-in period prior to randomization. Based on this progress we now expect to complete randomization of the 650 patients targeted for the ANCHOR trial before the end of 2010, well ahead of our previous guidance of completing randomization in 2011. Furthermore, we anticipate reviewing and reporting top line results for ANCHOR in mid 2011.

Our team has been working diligently to progress these trials. Clinical investigators have been enthusiastic in their support and we have been experiencing a favorable patient dropout rate, a rate much lower than expected. These factors have contributed to the progress we have made thus far in the execution of these trials. You may recall we began this year projecting clinical trial results in 2012. It is very encouraging we're in a position to report results of both trials by mid 2011 including report of MARINE result before the end of 2010.

Our confidence in the success of these trials is based on extensive historical clinical experience gathered over many years and many patients which suggests that over 96% pure ethyl-EPA, which is the active component of AMR101, is both safe and effective in lowering triglyceride levels.

Once the trials are completed it is our aim to promptly report on the top line results and to follow up with further communication via presentations at major scientific meetings and published papers. The timing, location and content of such presentations will be communicated when final.

Briefly, for anyone on the call new to Amarin, AMR101 is a prescription grade semi synthetic form of eicosapentaenoic acid, or ethyl-EPA, an Omega-3 compound being developed and positioned as a best in class prescription medicine for treating patients with elevated triglyceride levels. It as single active moiety with a promising safety profile and strong scientific and clinical evidence supporting its efficacy in lowering triglyceride levels.

Elevated triglyceride levels are increasingly being recognized as a significant modifiable risk factor for cardiovascular disease, alongside LDL cholesterol. For example, in a clinical trial in Japan, the JELIS study, the Japanese EPA Lipid Intervention Study, the treatment of patients with statin therapy plus 96% EPA resulted in a 53% reduction in cardiac events compared to patients treated by statins alone in patients both with elevated triglycerides above 150 milligrams per deciliter and low HDL cholesterol. Among all (inaudible) patients the trial, a majority of which did not have elevated triglycerides, there was still an impressive 19% reduction in coronary events. Both of these results were both statistically and clinically significant.

As you 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, that is over 500 milligrams per deciliter. (inaudible) this trial can support a label similar to the billion dollar drug Lovaza, or Omacor, which is also a prescription Omega-3 marketed by GSK in the US and Abbott in Europe. The MARINE study is the largest ever study conducted in this population and the first study with Omega-3 fatty acids in what we refer to as the post statin era.

The ANCHOR study valuates the safety and effectiveness of AMR101 in patients with mixed dyslipidemia who have high triglyceride levels of 200 to 500 milligrams per deciliter, and who are also on statin therapy. In the US, no prescription Omega-3 product is approved for this population. This study will also evaluate whether AMR101 is devoid of the LDL elevating effects commonly seen in patients with mixed dyslipidemia on statin therapy who take concomitant prescription Omega-3 therapies.

It is important to understand that the patients in the MARINE and ANCHOR trials are metabolically different populations. For example, the causality of very high triglycerides may be different to that of high triglycerides. Also, LDLC is not the primary lipid of clinical concern in our MARINE patients while it is the primary clinical lipid of concern for an ANCHOR patient. As a result, it is important to understand that the patient populations are using different background therapies. The ANCHOR population is starting from an already modified lipid baseline that controls the LDLC and lowers triglycerides as compared to the MARINE patients. As such, when the MARINE data are reported we should not extrapolate [the likely] to the ANCHOR patient population as these studies are truly two different patient populations and Amarin is pursuing two separate labeled indications.

While we have reason to be optimistic about the results of both trials if the MARINE results do not meet the primary endpoint Amarin will still pursue an indication for ANCHOR and vice versa. I will be available at the end of the call for questions you may have regarding our clinical trial progress. And in accordance with the agenda that Joe laid out, I will now pass back the call to Joe.

Thank you, Declan. In my introduction today. as many of you saw in this morning's press release, the Company announced some management changes. In addition to my current role as Chairman and becoming CEO, we also announced that John Thero has been promoted to President. He and I look forward to working very closely together in these roles and being supported by Paresh, Declan and all of the members of Team Amarin. Colin is no longer with Amarin as he resigned to address personal matters. He was our former CEO.

As you know, I joined Amarin as Executive Chairman at the beginning of 2010. The progress has been phenomenal. The investors who put the dollars into the Company in October couldn't have asked for any better results. We are now within a month to two months of seeing top line results from MARINE. And ANCHOR following quickly in the middle of 2011.

This progress has occurred, really due to the dedication of the team, faster than we originally expected and really due to the team's focus on execution and a sense of urgency. My role going forward will be critical towards maximizing shareholder value by aggressively looking at all opportunities and aggressively pursuing all challenges in terms of resolution.

Assuming we receive positive clinical results, we will continue to focus expeditiously towards pursuing regulatory approval, rapidly and aggressively sorting through commercial alternatives, and that we take care of operational matters along the way. The Amarin R&D team is a distinguishable strength of the Company and a real focus and again I compliment them all on the success in getting us to this very important point today. I look forward to building on that foundation as Amarin becomes increasingly commercially focused.

In that sense we can be a best in Class relative to the other therapies on the market and particularly what Lovaza provides today. Among the attributes to distinguish us, AMR101, from Lovaza is a potential for a lower pill burden, two grams a day, two pills versus four per day for Lovaza, and the potential for mixed dyslipidemia indication with much greater market opportunity. I note that Lovaza is not approved for this and that the mixed dyslipidemia confers incurs a high risk for cardiovascular morbidity.

Elevated triglycerides have been increasingly recognized as an independent risk factor from cardiovascular disease, so while statins form the traditional backbone of lipid lowering cholesterol a high residual risk of cardiovascular events remains. As Declan noted, our MARINE and ANCHOR trials are studying two separate patient populations with elevated trigs. We believe that both populations are larger and under served. US clinical treatment guidelines recommend that all people with triglyceride levels of greater than 200 mgs per deciliter be treated with triglyceride lowering therapies. However, the ultimate result is that less than 4% of such patients currently receive treatment. We believe that AMR101 can overcome limitations of currently approved therapies and provide a real benefit to patients and caregivers alike.

There are approximately 3.8 million patients, people in the US, with very high triglyceride levels greater than 500, theindication for which Lovaza is currently approved. Lovaza, which is selling approximately $1 billion a year based on this indication alone, has been growing revenues rapidly and we believe there is considerable room for further growth. Separately, there are nearly ten times this number of people with triglyceride levels between 200 and 500 milligrams per deciliter. A large portion of the patients in this category are on statin therapy for the treatment of elevated LDLC.

As Declan commented, no prescription Omega-3 based drug is approved for the treatment of triglycerides for such patients. If, we as expect, AMR101 is shown to not increase LDLC we believe that this will be a tremendous opportunity for us. The results of MARINE and ANCHOR trials will prove just how good AMR101 is at reducing triglycerides. Noting however, that we already know that AMR101 has promising efficacy and safety profiles supported by experience with Epadel, a pure-EPA product marketed in Japan since the early to mid 1990s. Epadel has been shown in multiple clinical studies to reduce elevated triglyceride levels. Further, Epadel and AMR101 have separately demonstrated in clinical trials that pure EPA has a promising safety profile.

In addition, the JELIS study in 18,500 Japanese patients, referenced by Declan, remains the only study of any drug to show statistically significant improvement in CV outcomes incremental to statin therapy.

Assuming positive Phase III results we will be moving forward in parallel with an NDA filing, the path for which is made clear by the FPAs we already have in place and commercial preparations. As we said before, the path to commercialization of AMR101 is most likely with a large commercial partner. Our aim is to evaluate multiple opportunities for commercialization and to select a choice which provides the greater shareholder value. This is an area in which I have considerable experience and which I look forward to playing a particularly active role.

On the partnering front Amarin is already active in partnering discussions with multiple potential partners for commercializationWe see this as an opportunity and a good strategic fit for many potential partners. In addition to outright partnering, we are also considering other possibilities that could go as far as co-promotion and from there other targeted audiences that Amarin could participate with themselves. But again the overall goal is find a partner and we think there are a number of them out there that this drug would fit right into their portfolios. I'll be available at the end of the call if you have any questions. Before we get there, I will turn the call over to John for comment.

Thanks, Joe. Like Joe, I'm very optimistic about Amarin's future and look forward to working with the Amarin team to maximize shareholder value.

Consistent with the intent of this call my focus on these comments will be on Amarin's Q3 financial results. Amarin's cash balance at the end of September was approximately $31.4 million, a reduction of approximately $6.2 million versus our cash balance at the end of June.

The Company reiterates its guidance that its current financial resources are sufficient to finance planned operations through completion of the ongoing MARINE and ANCHOR Phase III clinical trials including the reporting of results from these trials and, assuming clinical success, through a submission of an NDA for AMR101. The $6.2 million net cash outflows during the three months ended September 30, 2010, included approximately $5.5 million paid in connection with the Company's two Phase III clinical trials. This $5.5 million inclinical trial costs does not include our own internal staffing costs but does include costs for the MARINE and ANCHOR trials related to patient screening, randomization and treatment.

While we have not provided guidance regarding quarterly cash spending levels it is reasonable to assume that clinical trial spending for MARINE is beginning to slow as patient screening and randomization are complete and the dosing period is near the ending.

The Company's cash outflows during the quarter were partially offset by $2 million in net proceeds received from the exercise of warrants. The warrant exercises, at exercised prices from $1.00 to $1.50 per share, resulted in issuance of approximately 1.5 million shares during the quarter ended September 30, 2010, increasing the number of outstanding shares to approximately 1.2 million (sic - see press release)shares.

As of September 30, 2010, in addition to the shares outstanding, we had 38.7 million warrants outstanding at an average price of $1.77 per share and 12.3 million stock options outstanding at an average price of $2.47 per share.

As you may have noticed, Amarin recently filed two registration statements. Please note that under SEC rules, Amarin was not eligible to file short form registration statements until recently. One of these registration statements is a replacement for the long form resale registration statement we filed late last year in order to register for resale securities sold by Amarin prior to that registration statement. There are no new shares being sold by Amarin under this registration statement.

The second short form registration statement we filed is often referred to as a Universal Shelf Registration Statement. This registration statement would allow us from time to time to issue registered securities for capital raising purposes. We are filing this registration statement because we are now eligible to do so and because we believe that having a Universal Shelf available to us is consistent with good corporate governance, because it helps to facilitate our access to capital. We do not currently have any plans for financing.

Neither registration statement has been declared effective by the SEC, which we expect to occur following a customary review process. Additionally, as you may be aware, Amarin has had an agreement with a group called Scarista Limited, under which agreement Amarin was obligated to pay a royalty of 7% on certain sales. This royalty originated with Amarin's prior acquisition of certain neuroscience assets. Amarin recently entered into an agreement with Scarista Limited, whereby in exchange for Amarin licensing certain neuroscience assets back to Scarista Limited, the 7% royalty is eliminated, thereby removing any risk that such could be claimed on cardiovascular related sales of AMR101.

Lastly, as part of the recently awarded grant under the Qualified Therapeutic Discovery Project tax credit program, Amarin recently was awarded and paid approximately $244,000.

With that said, I thank you for your attention today. I know we have covered quite a bit, we would now like to turn things over to questions. Operator?

Thank you. (Operator Instructions). Our first question is coming from the line of David Moskowitz of Madison Williams. Please state your question.

Yes, good morning, everyone. I have a question. I guess these are a couple of questions for Declan. First, can you explain to us how these trials end up accelerating faster than your expectations? I mean congratulations on that, that is great news. And I'm sure there is different reasons for the two different trials moving faster. Can you go over those reasons for us?

Basically the acceleration of the trials is due to a number of factors. It is really all about execution and over my many years of experience in clinical trials it tends to be the other way whereby you tend to announce delays rather than accelerations. I put this down to, one, the partnership between the clinical operations team led by Rene Braeckman, under Paresh Soni's guidance, and the relationship between the CRO Medpace and therefore also the clinical trial sites. It is probably also an indication of the enthusiasm that the clinical trial investigators on the staff have for such an approach, i.e., Omega-3 use in triglyceride reduction and the fact it is a very well accepted therapy by the patients in terms of tolerability.

So I think that what we would say is that we realize there are large patient populations out there. We didn't quite know how it was going to play out in the final analysis but I think we were reasonably conservative in our estimations of the trial timelines and we were pleasantly surprised but not overwhelmed by the fact that when all the elements come together, the patient availability, the clinical trial partnerships, then the trials can come in ahead of schedule. And the MARINE -- sorry , the ANCHOR study is, indeed, on schedule.

Excellent. And could you also in conjunction with that go over your view of the margin of confidence you have in the clinical studies, particularly the MARINE trial offering a potentially favorable result?

So we draw on evidence from the literature. And using that as a basis, first of all, for assessing the likelihood of success, I am confident that EPA alone will, indeed, reduce triglycerides and we have reviewed the literature and we have come to the conclusion that there is a likelihood of this triglyceride lowering. In addition, we have seen from analysis of AMR101 and Epadel, which is the product in Japan, that triglyceride lowering does, indeed, occur. Now, with regard to MARINE, MARINE includes patients at levels above 500 milligrams per deciliter And we have seen robust decreases in triglycerides in patients treated with Lovaza and I believe that we will see that AMR101 is equi-effective with Lovaza.

Okay. And I mean Lovaza is a different product, it has two component ingredients. Can you speak to the comparability of EPA relative to DHA in terms of triglyceride lowering?

What we are seeing is that EPA and DHA independently can lower triglycerides. What we haven't really been able to sort of tease apart is the synergy or antagonistic relationship between EPA when combined together in triglyceride lowering. What I am pleased to say is that we believe that the magnitude of the triglyceride effect should be similar to that of Lovaza.

Okay. And last question which is more on strategy, you guys mentioned that you are in discussions with a number of strategic -- potential strategic partners. Could you give us a little bit more on that? For example, perhaps a rough idea of the number of companies you are talking to and the type of pharmaceutical partners you are talking to?

Yeah, hi, this is Joe Zakrzewski, thanks for the question. I would just say we are talking to in some level or shape or form greater than five, less than ten. And they are the top of the class that you would expect it to be for an opportunity of this type. And we are delighted with the progress so far. But like everything else, it is a question of the value proposition and we believe that this is really second to none so what is out there is a very, very limited opportunity in late stage assets and see where we end up going. This is one of the things that I'm going to spend a good, good portion of my time doing and working with John and Declan and Stuart Sedlack, who is our business development head, but we are very optimistic.

Again, I think the nice thing for us is we really control our own destiny. And by that I mean we have a multitude of options ourself, with partners, et cetera. And again, the key thing here is to do it with a partner, okay, in some way, shape or form. But this is an asset, and I will go back to my Reliant experience where we have the ability to really, really do something clearly better off with a partner. But if not -- if not, then we will deal with that.

Okay. Thanks for taking my questions. Appreciate it.

Thank you. Our next question is from the line of Ritu Baral of Canaccord Genuity. Please proceed with the question.

Hi guys, congratulations on the accelerated timeline. Question for Declan, From the MARINE data what can we expect as part of the data that is a released along with the triglyceride data? Will we see LDL mean and outlier data as part of that? And sort of to go along with that, which conferences are the likely suspects or appropriate venues for full presentation coming up?

Thank you, Ritu. We will provide investors with information on a top line basis sufficient to allow the likes of yourselves and our investigators the information to judge the results of the trial. We are working out these details but probably fair to assume we will report P values and some characterization of triglyceride levels and change.

We are focusing on the (inaudible) part of the trial but also seek to provide reasonable perspective to the extent possible based on top line review and limited time of the data. Of course, we want to provide further detail throughout subsequent presentation at industry forums, the usual kind of academic cardiology conferences and through publication. And it is also important to note that we will present the full results in a peer reviewed journal, make presentations at such meetings and so therefore we have got o be very cautious not to have any release of results compromise such publications, but at the same time are sufficiently informative when we produce the top line data so you guys can make a decision in the trials.

Okay.

We haven't actually determined which symposia we are going to present the results at yet.

Okay. And then following up to David's question. You mentioned that you expect equal triglyceride lowering efficacy. Do you expect to see this at the high dose or would you see this at the low dose as well given the potential potency of EPA?

I think that we're saying we always considered AMR101 with pure EPA as able to provide effective triglyceride lowering therapy and that we are not predicting superiority in triglyceride lowering over Lovaza. We would suggest that it would be in the same range. Now, what we are not going to do is say and we are going to line up the MARINE data with another trial of Lovaza because of differences in the selection criteria, et cetera. But I think across the board we believe we would offer in the same ballpark of effect on triglycerides as Lovaza.

Okay. And then the efficiencies that you have seen in the MARINE trial that have led to the accelerated pace, in addition to enrollment you mentioned that crunching the numbers essentially will take less time than you thought. Will this translate to ANCHOR as well?

So we believe that the same model will apply in terms of our ability to access the clinical [patient record] forms, the cleaning up of the data and reporting. So I would think the same efficiencies will have actually been garnered for both and the team will have to a certain extent learned from working with MARINE as to how to do at least as well with ANCHOR.

Okay. And you did mention that the dropout rates look good. Do they differ between the trials?

We are not going into that level of detail at this point.

Okay. And then any updates on the outcomes trial that is planned as well as your current IP position?

We don't have any updates on this practice for this call today, Ritu.

Okay, great. Thanks. I'll hop back in the queue.

Thank you.

Thank you. Our next question is coming from the line of Duane Nash of Wedbush Securities. Please state your question.

Good morning and thanks for taking the questions. Who, if any one in the company, has had access to the MARINE data? For example, one question I have been getting is, is there any possibility that actual results of the MARINE trial played any role in Colin Stewart's departure?

I will answer that from the medical perspective. The trials are [unblinded] and there is no one in the Company with access to any results.

Okay.

On the other side.

Joe?

This is Joe and I'll ask John to comment. Colin is dealing with a personal matter and we respect his privacy. And I would tell you that it had absolutely nothing to do with that. Again, there was no data. We wish Colin well, but based on the discussions with him this was the path we decided to take forward with the new executive team.

Understand. Thanks for the clarity. And then the follow-up question. I was impressed to see that the trials are moving ahead of expectations and is this purely due to execution or is there any way that actual results being either better or worse than expected could cause these trials to move ahead of prior expectations?

I will take that, Duane. No, it is simply an execution story. It is not a results contingent performance because the trials are still double blind and we have not had access to the data at all.

Great. Thanks very much and congratulations on the quarter.

Thank you.

Thank you. Our next question is coming from the line of Joseph Schwartz of Leerink Swann. Please state your question.

Good morning and congratulations on all the fantastic execution. Wondering if you could give us your sense of what you would expect the geographical distribution of patients in both studies to be?

Declan Doogan here. During the ANCHOR trial this was conducted in the US. In the MARINE trial we conducted it both in the US, western Europe, and other territories such as Russia. The actual distribution of those we are not describing at this point in time but I think it is safe to say it is genuine global multi-center study.

Okay. Would you expect the baseline triglyceride entry level to be any different from -- in either -- in any of these territories or very much different than the Lovaza studies?

So our selection criteria were unique to MARINE in that sense because we [targeted] for what we thought would provide the best signal of benefit in the MARINE trial. Having said that, the level we set was a minimum of 500 milligrams per deciliter, and it matters little whether it is in Russia or the US because we are talking about a biochemical level. Having said that, it would be a logical question to say well, the mean results in Russia are different from the mean results in other regions and that is something we will look at. But we have no information on this at present.

Okay. And I saw that you renegotiated your supply agreement, which can go out for another ten years and there are contractual minimums until NDA submission. I'm wondering what is the maximum capacity that is possible out of there and how are you doing on finding additional suppliers?

This is John. I'll take that one. So this is an agreement with the supplier that has been very supportive of us for quite a while, over a decade. As many of you know they (inaudible) on file in the EU and in the US. Key parts of this agreement with them was in fact establishing that there would not be a conflict with our going to additional suppliers. We are in the process of qualifying additional suppliers. The supplier that we do have is -- they are responsible for expanding their capacity. They would very much like to provide us with all of our capacity requirements. We think it is good practical business risk mitigation to have multiple suppliers. The time frame for scaleup of these kinds of suppliers tends to be in about the12 month or so range and we are currently working with them. And capacity levels support hundreds of millions of dollars in revenues but with plans for substantial expansion beyond that.

Great. Thanks very much.

Thank you. Ladies and gentlemen, we have time for one more question. Coming from the line of Bill Tanner of Lazard Capital Markets.

Thanks for taking the question. Declan, you did mention that the dropout rate was lower in the trials. And I'm wondering if there was anything to read into that just in terms of tolerability. If it was benchmarked, the anticipated rate on maybe the dropouts for Lovaza. So is there something that one could read into that this is providing some kind of a differential tolerability advantage?

Thanks, Bill, for the question. I would say that we always wanted to be conservative in our estimate so it wouldn't be disappointing down the line when we were managing this study and projecting the study results. First of all, I think you would just say it is a general descriptor of how well the drug is tolerated in the clinic. It is also fair to say that the patients and the investigational staff worked together very well to maintain patients in the trial and I wouldn't look into any further to say that therefore it is better tolerated than Lovaza. That has not really been the thesis of where the program -- I think that the Omega-3 fatty acid platform is actually a very well tolerated and safe approach to treating patients and I'm pleased that the dropout rates actually underpin that.

And then maybe just a question for Joe. It is probably unfair since you are new on the job, but when smaller companies think about co-promotes it is obviously , or not obviously often times, with an eye towards expanding the pipeline or backfilling the pipeline if you will in licensing things that are complementary. Any thoughts on that now and specific areas, presumably cardiovascular?

Well, no, I would just say our focus right now is getting the MARINE data and getting the ANCHOR data and driving towards the submission as rapidly as possible and putting a partnership in place. And we had some offline discussions historically about how broad could you make this, how big could it get, how wonderful could it be but I think those are premature at this point.

Okay. Thanks very much.

Thank you. I would now like to turn the floor back to management for further and closing comments.

Thanks, everybody, for joining us today. We appreciate it. We look forward, of course, to moving forward and to seeing data and reporting that to you here in the next month or two. In the interim, if you have follow-up questions, please don't hesitate to contact us. We are also appearing next week at the Lazard Healthcare Conference in New York and we look forward to seeing some of you there. Thanks much. Good day. Bye.

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