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Amarin Corporation plc (AMRN)

Q1 2013 Earnings Call· Thu, May 9, 2013

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Transcript

Operator

Operator

Welcome to Amarin Corporations Conference Call to discuss its first quarter 2013 financial and operating results. This conference is being recorded to May 9th, 2013. I would now like to turn the conference over to Mr. Joe Bruno, Director of Investor Relations and Communications for Amarin.

Joe Bruno

Management

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 the Private Securities Litigation Reform Act. The example of such statements include but are not limited to our current expectations regarding financial performance and plan for commercialization of our approved products and product candidates including supply related activities and level of expenditures and revenues and the adequacy of our financial resources. Our current expectations regarding regulatory filings, government agency decisions, potential indications and commercial success for our product and product candidates. Our current expectations regarding our cardiovascular outcome study and the potential implications of such studies on our regulatory process plan to protect the commercial potential of our product candidate and approved products through patents, regulatory exclusivity, trade secrets and 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, May 9, 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 impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreement that we may enter into 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-K, 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 in Amarin and is not intended to promote the use of Amarin's Vascepa outside of its approved indication. In addition, please note these remarks will contain non-GAAP financial measures, as defined by SEC Regulation G. The GAAP financial measure most directly comparable to each non-GAAP financial measure used or discussed and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure can be found within our Q1 financial results press release. 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.

Joe Zakrzewski

Chairman

Thank you Joe and welcome to all those who are available to be with us today. During this call we will review our recently accomplishments and milestones, update you on the (inaudible) and other operational activities and speak to Amarin’s financial performance in the first quarter of 2013. We will also take few questions from those on the call. 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, Fred Ahlholm, our VP of Finance; and Joe Bruno our Director of Investor Relations. As our 2012 year end call we have advanced key objectives in a number of areas including recognized Q1 revenue from Vascepa sales of 2.34 million and this is part of the 5.2 million in sales for wholesales. The (inaudible) access for Vascepa was over 190 million lives and are now covered by payors including earlier than expected Tier-2 preference for 40 million of these lives to getting in April and May of this year. To see FDA acceptance for review of our supplemental NDA seeking approval for the marketing and sale of Vascepa capsules for the larger ANCHOR indication for use as an adjunct to diet and the treatment of adult patients with high triglyceride with Mixed Dyslipidemia. This is the group of 200 to 499 triglyceride (inaudible). We seek FDA approval for two additional active pharmaceutical ingredient manufacturers or API compilers both Chemport and BSF that increases to the number of three are now qualified API suppliers. We believe that leads the future API cost reductions of upto 50% or more. Increased patents issued or allowed are 22 in the United States, having added 11 since the end of 2012 including three since our last press release on this topic. All the two of…

Fred Ahlholm

Management

Thank you Joe. I will provide some commentary regarding our financial results and you will find a more detailed discussion of our results and our 10Q and press release issued earlier today. Amarin began recognizing revenue from the sale of Vascepa in the U.S. in January 2013. Though detailing of the product do not begin until Vascepa’s commercial launch on January 28, 2013. We reported net product revenues for the quarter ended March 31, 2013 of 2.34 million in accordance with U.S. generally accepted accounting principle or U.S. GAAP. We certainly have more operating history with the commercialization of Vascepa we are recognizing revenue not on our sales to wholesalers but on the resale of Vascepa by the wholesalers. During Q1 the net value of Vascepa sold to wholesalers was 5.2 million and as a result in addition to the 2.34 million in recognized revenue we reported deferred revenue of 2.9 million at March 31, 2013. Cash collections from the sales of Vascepa in the period ended March 31, 2013 were approximately 2.9 million with an additional 2.2 million related to the net Q1 sales collected from wholesalers in April 2013. Consistent with industry practice the net prices of Vascepa in Q1, 2013 reflected a deduction of a onetime discount made to wholesalers to stop Vascepa in advance of Vascepa’s launch in January 2013 as well as the cost of our co-payment rebate card program in customer payor rebates and allowances. Cost of goods sold during the quarter ended March 31, 2013 was 1.3 million. All of the Vascepa capsules (ph) sold during the first quarter of 2013 included API source from a single API supplier. Amarin’s purchases of API from the supplier in 2012 and early 2013 are at a higher cost for retail and expected for future purchases…

Joe Zakrzewski

Chairman

Thanks, Fred. As an organization, we are excited to report our accomplishments to-date regarding our launch of the MARINE indications and our operational activities. We are also excitedly looking forward to even greater opportunities, we move closer to December 20 and the PDUFA date for the ANCHOR indication. 2013 will continue to be a year of execution. We believe that we continue to reach our milestones as they relate to our operational priorities we will bring significant value to shareholders. These operational priorities includes increasing revenues from Vascepa through daily execution by experienced sales force as they continue along the path of success that they have crowded from February through today. In signaling the earlier than anticipated managed care migration from Tier-3 to Tier-2 coverage allowing more patients cost effective access to Vascepa. Gaining approval of the ANCHOR indication, it is sNDA PDUFA data is scheduled for December 20, 2013 about seven short months away from now. Our pending additional patent awards on the U.S. PTO further securing our IP position for Vascepa. And finally, continuing to excel and deliver on our current supply chain commitment, including the anticipated sNDA submission for our (indiscernible) high supplier all of which drive our cost of goods down significantly. Thank you for your time today and for your interest in Amarin. I would now like to open the call for a few questions. Operator?

Operator

Operator

Thank you. We would now be conducting a question-and-answer session. (Operator Instructions) Our first question is from Ritu Baral of Canaccord. Please go ahead.

Ritu Baral - Canaccord

Analyst · Canaccord. Please go ahead

Thanks guys for taking the question. Joe, some detail on the promotional efforts do you guys have underway, have you guys determined an average number of details required for prescription for your reps and you had mentioned that sort of threshold is being detailed five times, do you have an estimate of the percentage of your target docs that have been detailed five times to-date?

Joe Zakrzewski

Chairman

Yeah, well, Ritu yeah hi. Good to hear from you as always. I would tell you we are getting a lot of scripts written after the first, after the second, and after the third, but we see this inflection when we get about five or six. I would say to you we are probably depending on the data and how you look at it, because again don’t forget that we see this data a week or two behind. We are probably there with a week or two behind, we are probably there with the third to half of the folks and we continue to see this trend picking up and the whole awareness thing it's out there. So I would say about third to half we are there on. Okay?

Ritu Baral - Canaccord

Analyst · Canaccord. Please go ahead

And would you expect that all of the target (inaudible) and detailed five plus times five the next earnings call?

Joe Zakrzewski

Chairman

I would expect about 70% to 90% depending on where we end up and the reason I caveat that is and we had great receptivity from the doctor’s right? So they all want to see our folks but there is always a couple of them that may say you got to cancel or I have got this going or that going on or they might be in for example Wisconsin or Minnesota which is a little bit trickier to get to see them but I think we should see clearly significant gain as we get to the next conference call in the first or second week in August.

Ritu Baral - Canaccord

Analyst · Canaccord. Please go ahead

Got it and last question relating to interims coverage and prior auth.? Are there prior authorization requirements that any of your Tier-2 coverage is right now and what are the prior authorization requirements that you’re seeing either in these?

Joe Zakrzewski

Chairman

Yes most of them are not there at the Tier-2 side, if there are there might be somebody that says well because there is all the off-label stuff going on for your competition, we’re going to put in it at 500 for you and by the way we’re going to go back and grind further into them. It's a little trickier for us because clearly we are new in launching but what really happens for us assuming that that’s case and again it's limited on Tier-2 but when we get to ANCHOR if you think about it right now the catch is we are approved for the same indication as our competition, when we get to ANCHOR the answers we are the only one to prove for this we would see our prior auths dropping and all the prior auths for the competition staying in fact being added across the board. So what we’re really doing right now beyond getting our brand out there and getting to know all the doctors better and better, is we are building awareness and that’s a big thing, building that awareness because we know a 1000, 2000 docs before we launched pretty well the 30,000, 35,000, 40,000 will take a while to build the brand and we’re really starting to see that. On the other nice thing we are seeing is a lot of doctor testing themselves or their patients so we have one doc who not does LDL down almost in half when he switched from Lovaza to our product. We have other doctor with same trigs (ph) go down another 100 or 200 mgs (inaudible) on our products for their patients and try the LDL. We have seen other docs that see saying about the same but still driving LDL down and the more these doctors see that the more the doctors are sort of embracing our product and so between that the awareness and all the other stuff, we didn’t see this all coming to ahead as we launched ANCHOR.

Operator

Operator

Thank you. Our next question is from Joseph Schwartz of Leerink Swann. Please go ahead.

Joseph Schwartz - Leerink Swann

Analyst · Leerink Swann. Please go ahead

I wanted to get your thoughts on why you think you might be ahead of plan on the Tier-3 to 2 conversions and what are your goals for the rest of the year?

Joe Zakrzewski

Chairman

Yeah we setup Tier-3 to Tier-2 conversions originally that were based probably on what let’s call what we did with Lovaza plus a little more aggressive, okay? The reason we think we are so far ahead at this point is that A, the managed care plan get it. They get the benefit of the trig lowering with a no-LDL increase the no-(inaudible) label all the other benefits that we provide side effect wise and the inflammation markers. I will also tell you that sometimes the big pharma companies can be a little bit painful to deal with let’s say at these companies for managed care and I think we have been through this, we have tried to be nimble we have tried to be effective and I think they respect that they are not dealing with the behemoth, they are dealing with somebody that works with them. So I think and I also will tell you that I think you know at least in the lab (ph) basis our price is lower I think as you see people going into a launch of a new product and people start raising their, the competition, it rubs people the wrong way. So great products, great working relationship in terms of where we are going to end up now I would tell you we’re about three to six months ahead of where we expected and I expect that we continue to accelerate beyond that. I’m not prepared to give any other answers at this point. I would tell you that even once you get these lives, it still takes you two to three months to really pull them all through, because it’s just a more complicated market than it was previously, but we are really happy with where we are right now on the Tier 2.

Joseph Schwartz - Leerink Swann

Analyst · Leerink Swann. Please go ahead

Alright, great. That’s helpful. Thanks. And then you mentioned that you are not having to get big discounts, can you give us some insight into what the gross to net is?

Joe Zakrzewski

Chairman

I would tell you that the best thing I can say right now is the first quarter is an anomaly. What I said to people historically is our rack price, I think it’s roughly its $184 plus or minus a month which forecast to be above 50 uphill. I think we said to folks that roughly we expect to have the same net sales as our competition per pill was about up $25. We were a little below that in the quarter, a lot of that due to the coupon programming, different things of that nature. We had the biggest impact on that. It drives your net sales down, but I am not overly worried about what managed care is going to do it, because we are right on target with everything that we are doing, but without going into the first numbers, it should get better as we get out in the rest of the year.

Joseph Schwartz - Leerink Swann

Analyst · Leerink Swann. Please go ahead

Great, keep up. Great work. Thanks.

Joe Zakrzewski

Chairman

Thanks Joe.

Operator

Operator

Thank you. The next question comes from Thomas Wei of Jefferies. Please go ahead.

Thomas Wei - Jefferies

Analyst · Jefferies. Please go ahead

Thanks. I wanted to get a little bit more of an update on your thoughts and the progress you’ve made towards determining the commercialization strategy for the ANCHOR indication?

Joe Zakrzewski

Chairman

Yeah, I mean, Thomas, we are heavily into that as I always – as I have been saying lately, we focus on those five key things driving sales, driving managed care, driving ANCHOR patents, driving ANCHOR approval and supply everything else would take care of itself. We still are in what I will consider, sure, if guys as always dialogue, I don’t want to say too much else. I think what I would continue to say though is we don’t see ourselves hiring a primary care sales force. They have a lot of unique ways you can do this, and we are aggressively looking at all of them, but I think the (indiscernible) right now would probably be premature and presumptive.

Thomas Wei - Jefferies

Analyst · Jefferies. Please go ahead

Can I just clarify when you say not hiring a primary care sales force, does that include or basically does that also preclude the option of a contract sales organization to market ANCHORs that you are really looking towards the partnership crew?

Joe Zakrzewski

Chairman

Yeah, no, it doesn’t preclude that. What I would say to you is as I think you have said before is that from a partnership perspective, you are really trying to do something you want to tie the assets up, you don’t want to sell the company by another means, long-term licensing deal. What you might do is co-promotion deal, for example, where you could access a thousand reps, for example, that are out there for a few years, just as an example, okay. And whether you do that will take form or contract sales, who knows, I am not big on contract sales organizations, yet you have to have the people to have accountability to somebody, and not that the contract sales organizations don’t serve a purpose, but those folks really don’t work for anybody. So, I think the people really need to work for us or they need to work for somebody else. I think the (indiscernible) you should be thinking about when I talk about primary care is primary care is 500 or 1000 additional reps. That’s not something that we intend to do, right, that’s just people shouldn’t expect to wakeup tomorrow and we are announcing hey, look at this we are hiring all these people, that’s not what we are going to do, it’s about being efficient and leveraging. And then of course, there are other options out there where other creative structures could come into play.

Thomas Wei - Jefferies

Analyst · Jefferies. Please go ahead

Thanks. That’s actually very helpful. And then just one last one, I am trying to use like you said about cash burn to get a better sense of how to model out the R&D and the SG&A lines, especially I guess the SG&A lines for the rest of quarter, is any other help that you can give us on how to think about SG&A relative to the first quarter?

Joe Zakrzewski

Chairman

Well, I don’t expect SG&A to grow significantly from here, okay or at all. In fact it might actually come down a bit. And what I really expect to see happen are the sales to continue to grow and if sales continue to grow and SG&A, let’s call it, flat who knows where it went up exactly. That’s my comment on why I expect cash to continue to drop as we go by. Again, I am sort of looking into a crystal ball here, Tom, as you know, because there is a lot of things that we don’t know yet. We are seeing great script trends so far. We think for the last few weeks last few weeks we were close to 3000 on TRx’s over 3000 if you use normalized TRx’s last week and we like what we are seeing, we like to response from some of the doctors, the managed care, we like the shipping patterns, the buying patterns, we are seeing both from the wholesalers and then shipments to retailers, it feels right for us.

Operator

Operator

Thank you. Our next question is coming from the line of Jonathan Eckard of Citi. Please go ahead. Jonathan Eckard – Citi: I was wondering if you’re able to provide any kind of relative details about the negative sampling program versus the amount of scripts you have in the first quarter and if there is any feedback on the conversion rates of patient getting samples that convert to scripts and what the potential impact of this could be in the next few months as you do see patients convert.

Joe Zakrzewski

Chairman

That’s only too much on the sample side, we have done quite a bit of it, we have had two different samples out there, we have had what I call two to four day sample packs out there and then we have got the initial program we had with the one month sample packs out there that were trying to get our high prescribers going. Those were pretty on everyone’s hands and I think we expect to see those sort of going away. What we’re trying to do is set this up where doc is reaching to his closet grab a handful of samples, given them to a patient, potential patient and maybe that upto a week of supply or four to seven day supply and then they get the script written. So I think the samples are always been an important part for us but when you’re dealing with the four gram per day drug and one that’s frankly doesn’t have cost of goods approaching zero then you got to be careful how you manage that, I expect we will continue to see very robust returns from our samples, to-date it's been very, very positive with those doctors who are using samples and accessing samples. Given out any more information in that probably a little tricky, John I think just to be clear the sample numbers are in our marketing expense

John Thero

Analyst · Citi

They are.

Joe Zakrzewski

Chairman

They are so they are not, sometimes people say oh are they in your cost of goods? But they are in our marketing expense and I think we would probably expect the sample not the big bottles going forward that was a onetime program but I think the small sample packaging grab them to give to the patient and get them started is really what we are going to be about going forward. Jonathan Eckard – Citi: Okay and if I can just ask a quick question, if I take your normalized script numbers that you have in the press release and compare that to the sales number, equates to 223 per script. I’m just wondering is that difference because the normalized script numbers are maybe a little off or how you accounted for?

Joe Zakrzewski

Chairman

Yes I have a feeling well I don’t think those are comparative Jonathan because what’s happening is we know there are more shipments being made we worked very closely with our accounting firm to figure out what the net sales were and so it's not an apples to apples comparison, John you want?

John Thero

Analyst · Citi

That’s right thing and our revenue is on the data and we provide that data more on the scripts, this is what’s available on the (inaudible) and we do think it's representative of the month to month trend as we Fred stated in his comments we believe those numbers are understated and take one data that’s available to us we recognize revenue based on what we believe the actual level of activity was out there. So the number of scripts in which generally recognize higher than the number that you’re referring to.

Operator

Operator

Thank you. (Operator Instructions). That is all the time we have for question, I would like to turn the call back over to management for any additional remarks.

Joe Zakrzewski

Chairman

Look everyone it's great to have everyone on board on the call. This was our first quarter of launch, a partial quarter two months, we look forward to chatting with everyone our first full quarter in August but all the signs we’re seeing right now, we feel very good about from the sales side, the managed care side the R&D side, the legal side, across the board things look very positive. I did want to make one other comment that based on a number of call that have gotten today on the New England Journals, medicine article that some of you not may have seen I guess that’s call on article it's probably more of a compliment than it should have but again as we see these things come out we see these as been the wrong drug and a supplement, I think along those lines that the patient protected was neither the marine nor the anchor group totally different, trig lowering people are commenting that they said that they had significant trig lowering results. They lowered trigs 2% to 3% significantly. No data on biomarkers, but you know that the study has been going on since ‘04 and has several significant challenges to it. I think it depends on the day for us, it’s about JELIS. That’s the best comparator for our study, for our drug. And JELIS is the study that in Japan saw a 19% reduction in mortality with our (indiscernible) and when they looked at patients at higher trig levels, they saw 53%. That’s the one we should be thinking about, and that supplements not poorly designed old studies. And I guess the simplest way to put it at the end of the day is that we took that drug that 1 gram drug that by the way was prepared to be half EPA, half EHA, and 20% other stuff, we ran that in the ANCHOR trial or the MARINE trial, it would have failed. So, why would an outcome study, so Steve do you want to say anything, tell us about that study at all that I get it?

Steven Ketchum

Analyst

No, this has been literally lower dose, different patient population and totally different product with a mixture of Omega-3.

Joe Zakrzewski

Chairman

Again, I wanted to comment on that, I thought I would get some questions on it. I am glad I didn’t, but during the calls we have done I wanted to make sure before we covered it. John, you have?

John Thero

Analyst · Citi

If I could just add one clarifying comment to something that was stated earlier just to make sure it only misinterpreted it. It was why we are talking about the managed care and just how the castle price that was referenced was formally discounted it was not over discounting the managed care which includes stage of wholesalers for their role through returns, allowance, and co-pay cards, this is a rolling number, so I don’t want to be, I think that that’s the level that we are discounting to payors.

Joe Zakrzewski

Chairman

Very good. So, just again scrap price is a $1.50 a fill, net sale we think ends up about the standard competition per fill was up 25, but that’s all in all discounts. It was lower than that this quarter again in early launch in May. So, with that, I want to thank everybody. I know we will be talking to folks over the next couple of days, and we very much appreciate it. Take care. Good evening.

Operator

Operator

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