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  • Amarin: How Cost Cutting Affects Cash Burn And Profitability [View article]
    My concern with the company saying 80 million next year in cash burn is that they say that in one breath and then in another breath say they may need to stop REDUCE IT but maybe not. Seems stopping it or continuing it could mean 10-20 million or more difference in 2014 so how can they give 80 million and not KNOW if they are continuing REDUCE IT? So they either have decided what they are doing and not sharing or the number they give is unreliable?

    My assumption is the 80 is with REDUCE IT as they should give guidance on how things currently are but based on this article leads you to believe its without REDUCE IT. The management number also means they have a 2014 sales estimate in mind, but they have never given sales estimates so at this point management projections have to be taken with a huge grain of salt.

    The numbers in the article are as good as any and with some sales pop they can get to Reduce It completion without going BK, they can definitely get to 2015 interim review. Its the entire value of the company in reality so stopping Reduce IT is stupid. All focus should be on completing that study(after they exhaust all Anchor approval possibilities of course)
    Nov 15, 2013. 12:54 PM | 2 Likes Like |Link to Comment
  • Amarin's Q3 Call Points To Dark Days Ahead [View article]
    The value of AMRN is Reduce It, not Marine. With Lovaza generic in 2015 AMRN will struggle to ever get profitable on Marine. They expect interim data to be analyzed by end of 2015 on REDUCE IT, they need to get to there before pulling any plug. If the study is a go from there you have 2 years to completion and if things look positive you find a way to finish it. With FDA requiring outcome studies for this class of drug if Vascepa has a successful REDUCE it they would be the only drug recommended with statins and will be for a long time.

    If Reduce it Fails lock the door, close up shop, or go to OTC fish oil if you have to. Marines value is minimal, the value was in Anchor and then REDUCE IT. Stopping REDUCE IT before interim review takes 100% of AMRN value away.

    They need to do whatever they can to get to REDUCE IT results, simple as that, it should be the #1 focus. So any plan they come up with it needs to be geared towards getting to REDUCE IT completion not stopping it and concentrating on marine indication.

    As for fighting the FDA, a lawsuit is the best option assuming feedback is not promising in discussions, they actually have legal grounds to sue and win though would take years and money but fighting them is a viable option because they do have legal grounds to sue and I think FDA lawyers would be weary of defending the FDA in this suit.

    I see no reason to hold the stock right now but if the stock is ever going to regain any potential Reduce It is the key.
    Nov 8, 2013. 07:58 AM | 2 Likes Like |Link to Comment
  • Amarin Could Still Turn Profitable [View article]
    What? They cannot cancel Reduce IT. It's the only real value in the company. You cannot rely on sales growth to cover expenses indefinitely. Lovaza goes generic in 2015, without Anchor approval doctors will have a hard time distinguishing between Lovaza and Vascepa and with Lovaza generic Tier 1 it will be hard to make enough sales to be profitable-especially with a skeleton sales force.. If the company has to partner for 200 million and give up 50% its worth it, a BP may take a flier because Reduce It success is a 10 billion dollar drug. If successful EVERYONE on statins will be taking Vascepa. They have interim data late 2015, at that point they can review and decide to drop but goal #1 should be to finish Reduce It or, worst case get to interim data, otherwise the company will either go BK or struggle along well below $10 for its existence and then go BK.
    Oct 24, 2013. 08:11 AM | 3 Likes Like |Link to Comment
  • Amarin Corp: An Oversold Investment Opportunity [View article]
    I think the issue is sales of Vascepa may be vastly overstated, they are cutting half the sales force and Lovaza goes generic in 2015. Without the expanded indication and a small sales force highly doubtful doctors will distinguish Vascepa from Lovaza to have people on Vacepa at tier 2 vs. Lovaza generic on tier 1.

    So it's not clear they can avoid BK and finish Reduce It and they need to finish Reduce It.

    If Reduce It is successful peak sales are likely near 10 billion so $23 is too low a target, however, unclear how fast generics would get to compete with Vascepa, could be 2020 , could be 2030, also the question of generics for Reduce IT etc...

    Way too many questions, cash burn you list maybe conservative and even at that they need to raise money.

    AMRN needed to partner last year but 100% they thought Anchor was in the bag. That management mistake has put them in a very difficult position. I strongly hope they get to Reduce IT finish, think odds are much higher than 50% since every comparison study with EPA and every study with similar target patients and similar improved lipid profile has been successful. Despite FDA Adcomm panel the science says 90% chance Reduce It is positive.
    Oct 23, 2013. 03:42 PM | 3 Likes Like |Link to Comment
  • Clock Ticks For Amarin As Outcomes Awaited [View article]
    The struggle for AMRN was the Anchor study was done so long ago(finished 2011) but needed Reduce IT 50% enrolled to ask for FDA approval and in the interim the Niacin study failed which was what killed AMRN as it does a lot of the lipid stuff Vascepa does.

    As with science the devil is in the details. The actual science that applies to Vascepa concludes Reduce It will reduce cardiac events. The question the FDA asked was would lowering trigs and other markers Vascepa lowers, added to statins, prevent CHD. Its a loaded question as it is not solely the lowering trigs that causes EPA to prevent heart disease, its anti-inflammatory properties and ability, in mouse studies, to remove arterial plaque amongst several reasons why it was successful in the Reduce it like study called Jelis. Even Niacin was successful in the population of people that are targeted with Reduce It.

    So you have Niacin study called failure that showed statistically significant reduction in cardiac events in reduce It population AND you ave Jelis study showing 53% reduction.

    There are no comparable fish oil or omega 3, to compare any other one to the level and type of fish oil Vascepa is would be ludicrous.

    If the FDA had focused the panel on EPA only the panel could conclude Reduce it was successful. Instead the FDA concentrated solely on lipid-markers, and ignored the studies that relate to pure EPA.
    It was a disgrace and if Reduce it ever gets finished, and here's hoping a BP buys in and funds it, the FDA members that help a biased and slanted adcomm should be fired.
    Oct 17, 2013. 02:12 PM | 9 Likes Like |Link to Comment
  • FDA Votes 'No': Is This The End Of Amarin? [View article]
    They need to partner or sell, simple as that. Omthera went for the equivalent of $3 for AMRN, you could easily see AMRN worth 5-6 with already approved for selling, on pace for over 100 million in sales in 2014 and Reduce It being underway where success equals gigantic sales.

    Well worth 700-800 million or so from some BP.

    Partnering would involve taking out debt and adding to sales force to sell in current indication and off label. This would allow company to finish reduce IT and still own a percentage.

    Those are the 2 best options. They need to find a way to get to Reduce IT as the science indicates strongly it will be successful despite vote today. Science is incredibly strong based on anti inflammation and reduction of artery plaque build up which was not allowed to be discussed today.

    They can get through 2014 with current cash, issue becomes 2015, they could be profitable late 2014 but unclear if they have differentiated themselves enough from Lovaza that when 2015 generics hit for Lovaza will they lose sales.

    The company has options to get to reduce IT. They will have interim data at 60% of events so interim data may be out in mid to late 2015, if interim is not conclusive enough may need to wait until late 2016 . So might be as long as 3 years to wait. Best option to plan for 3 years out is partner/BO.

    It's along term play but stock price could recover from sell off if company quickly gets BP involved. Of course a surprise FDA approval with the condition to revoke on Reduce It would do it but odds rather slim there.
    Oct 16, 2013. 05:15 PM | 2 Likes Like |Link to Comment
  • Was Amarin's FDA Briefing A Sign Of End Times? [View article]
    I just read the whole briefing and reading it all leads me to a much more positive outlook on Adcom. The FDA person writing the briefing pretty much says a couple things
    Mineral oil seems OK but placebo numbers for AMRN seem skewed. She goes into much detail as to how they looked at mineral oil and other uses show it is OK. She pretty much concludes that she has zero evidence that mineral oil did anything but should be discussed because placebo results look non typical
    Even with that main endpoint would be easily reached regardless

    She then goes into all the studies including JELIS and pretty much concludes....NOTHING
    She basically throws out studies showing both ends of the spectrum and says committee should look at them all and figure out if Vascepa will help heart events

    The only negative us they ask committee members to estimate likelihood of Vascepa helping cardiac events which is impossible for members to do as EPA works differently than all other fish oils, niacin etc tested as it is an anti inflammatory mainly. She wants them to decide if a better lipid profile leads to less heart issues which most on the panel still push that as being a good thing so hard of them to judge differently based on studies reported.

    I see how asking that question drove it down to 5.75 and then bloomberg article with misleading headline saying FDA requires outcome trial drove it to 5. Reading the details it seems ad comm members will vote overwhelmingly in favor but the details on what they feel about reducing cardiac events mat still give FDA pause in December.
    So Sell off overdone IMO and we will not get resolution from ADCOMM As FDA in December will still be debatable on direction regardless of Adcom.
    Oct 11, 2013. 06:17 PM | 9 Likes Like |Link to Comment
  • How Amarin Bulls Made The Right Choice [View article]
    WS reacted to uncertainty, way more positive than negative, the ONLY question is will panel thing Reduce It needs to complete before approval. Placebo question is a joke, not much other negative and much positive.

    The comparative studies were a joke also. Simply comes down to what panel member want outcome study before approval. AMRN has a lot of ammo to fight that need. Who on the panel will be able to fight back? Or even want to with such low side effects?

    We will see but article makes great points, Adcom has not happened, so today's sell of solely on one possible negative, will Adcom members solely look at that one thing and vote no?

    I'm thinking not but we wills ee
    Oct 11, 2013. 04:21 PM | 4 Likes Like |Link to Comment
  • AF Backtracking, AMRN Will Be Approved On Time [View instapost]
    Omega 3 studies are irrelevant to Vascepa, there has been only 1 known study on cardiac events and pure EPA which did show a benefit. Even the Omega 3 studies done were low dose and included DHA so are irrelevant to Vascepa. Statins have ZERO effect on increasing lifespans, meaning you die the same time whether on statins or not yet they sell 20 billion dollars based on a very small percent of people that actually get any benefit.
    Comparing the bad Omega 3 studies to JELIS or Vascepa is crazy and the committee members are not ignorant to science.
    So Zero studies showing EPA is not beneficial in reducing cardiac events and one showing it is beneficial. So if that is the central question then it's easily answered in the affirmative for Vascepa.
    Oct 2, 2013. 11:31 AM | Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    You lay out the bullish position really well(Which I agree with 100%). I've been thinking lately the company is in its best position ever. Exponentially increasing scripts, increasing Tier 2, coupons going away 2014 means more to bottom line, little real competition for many years, over 30 patents, Anchor approval coming and cash position solid thanks to recent raise..

    I'd say the things to temper the bullish side is
    1) GIA for Anchor means another 6 month+ wait to see if they can get Anchor sales to rapidly grow
    2) They give up too much in a partnership
    3) Launching to Anchor indication all out GIA would involve large costs that may bring the need for one more raise of cash.

    I think the BEST scenario is to partner with a BP with a plan that reduces partner take at Reduce It success, build Anchor sales rapidly, partner buys AMRN in late 2014 for nice premium.

    A non-partner approach can still lead to late 2014 BO but could be the one scenario where AMRN holds out until Reduce IT since a positive result in 2016-17 blows current valuations out of the water.

    If they cannot get something done with BP for Anchor, then we may not see the doubling of price until mid-2014 assuming they can successfully sell the indication on their own.
    Sep 30, 2013. 10:38 AM | 1 Like Like |Link to Comment
  • The Captain Of Amarin's Listless Ship Makes Ready For The Storm [View article]
    This is just plain out there as an article.
    1) The briefing book was not withheld, at the time of the comments it was still before the expected date to get the briefing books so if they had the briefing books at that time it would be early and out of the ordinary, to not have it was common practice for that far ahead of Adcom
    2) The weird bias angle makes no sense since, outside of NCE the FDA has been nothing but good to AMRN and besides the fact the initial papers sent on the Anchor Adcom to AMRN was cleaner than the one they got for marine.
    3) Tax rate in Ireland for a company not going to be profitable until 2015 + has no bearing on FDA decision-simple as that
    4) The whole Obamacare view makes no sense, Lovaza is a similar yet inferior drug already approved for Marina, if Obamacare never existed Marine would have been approved for Vascepa.
    5)The point on Lovaza selling off label is clearly showing another reason why FDA will approve Anchor yet you spun that negative for no reason I could discern from your article
    6) Anchor will be approved on time, to question that flies in the face of all known facts and anyone to suggest otherwise is severely misinformed as to how this all works.

    The questions with AMRN are whether they will partner or GIA and thus how quickly will sales ramp after Anchor-simple as that, there is little question that Anchor will be approved in December.
    Sep 20, 2013. 11:46 AM | 20 Likes Like |Link to Comment
  • Amarin And Teva: The Court Ruling And Amarin's Outlook [View article]
    Not a bad article, I will say your Reduce-It success sales numbers are way, way off. Reduce it is positive it means Vascepa prevent heart issues. That immediately makes it, not only prescribed at a level equal to statins, but also dramatically increases off label use.

    It's a 10 billion a year drug with positive Reduce It and you claim the model is based on positive Reduce It. If you read the details and see how small a percentage of people statins actually help, with side effects, and the enormous sales of statins then it is crazy to suggest doctors would prescribe at such a low level if Vascepa has a positive Reduce It. It is also the only drug of any competitor or near term competitor with such a trial so it would also eliminate competitive issues down the line. Other than that one every LARGE miss on numbers a very solid article.
    Sep 13, 2013. 06:44 AM | 5 Likes Like |Link to Comment
  • Amarin Initiated With BUY At Suntrust $15PT [View instapost]
    There are several "crucial" decision points. The first one is around December expansion of label to Anchor and how they launch that. If they partner, and they should partner, then that partner is the clear front runner to buy AMRN completely down the road.

    The next major time frame would be end of 2014 as that is the BO time frame that makes the most sense. I find it hard for a BP to justify a 5 billion+ BO with a company that has 40 million in 2013 sales. However, if they get to end of 2014 sales should be much, much higher, they would be as close as 2 years from Reduce It results at that time. Too far for AMRN to want to wait it out but close enough for BP to want to buy in. Stock price should be higher then also which makes BO premium not so large.

    If the do not partner and get to end 2014 then i could see a scenario where they dilute to get to end 2016 and wait for Reduce It results. I think that it is a plausible scenario though partnering for Anchor is, by far, the best approach. It still remains to be seen if they can conclude a partner deal that AMRN can live with for Anchor launch.

    But I do believe any BO scenario will not play out until 2nd half 2014.
    Sep 5, 2013. 11:39 AM | Likes Like |Link to Comment
    The original poster is a little off on what was stated. The FDA OK'd mentioning Anchor data on label once REDUCE IT was 50% enrolled so that is nothing new as has been 50% enrolled since launch. The NEW info was that they could also mention JELIS Study dats starting in August in sales calls as this was prohibited before.
    There is NO mention of approval to sell to another indication but more related to marketing communication intent.
    Original note on this below:
    rec'd call from fund source with ++ co sales contact, FDA has approved company use of A + JELIS results for sales calls beginning in August this is potentially huge in relation to sales and the run to Anchor allows company to warm up the space well in advance. Also, word was that PFE definitely in the mix for a deal. but the FDA part was presented as hard fact. as was relayed to me, co can use A + JELIS data soon. whether that turns to off-label is docs choice i suppose. seems like a left-field out of blue thing, but trust me, this guy never calls me. i call him. so this was notable.
    Jul 19, 2013. 10:25 AM | 2 Likes Like |Link to Comment
  • Acasti Pharma: Increasing Investor Interest And Volatility Likely Cometh [View article]
    Very well done article, good comparisons with AMRN. The issue I have with Krill oil is, as you mentioned stability of krill oil and thus high manufacturing costs.

    It also contains DHA which seems less favorable these days as many studies seem to indicate the EPA ability to reduce inflammation is a key to fish oil benefits.

    Some studies on DHA alone have negative implications while there is nothing but positive results from EPA. Though the vast majority of studies show some mild positive for DHA.

    As an investment I expect studies to be positive so a short term pop could be expected, long term I have doubts as they will only be in the Very High trig market initially and that won't happen until near 2015 when Lovaza goes generic. By time they even get a chance for the high trig market Vascepa will own the market and likely have REDUCE IT results at the same time and if they are positive that's ball game in terms of market penetration. Prescribe a proven drug to reduce cardiac events OR one with DHA in it that has no such study. So, short term, potential gains, long term, rougher seas.
    Jul 19, 2013. 08:42 AM | Likes Like |Link to Comment