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Steve Rosenman
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Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
  • More Positive Amarin Developments This Week 20 comments
    Jul 19, 2013 9:49 AM | about stocks: AMRN

    While multiple followers have emailed me about some comments by someone named Jeerio re: FDA allowing JELIS data to be included when marketing Vascepa, I have no information to contribute whether that is fact or fiction. While it would seem positive, I would tread carefully with that information.

    I will say I have been able to confirm that Vascepa will have expanded label data by end of this year, based on enrollment >50% for Reduce-It. This is very significant and if WallStreet actually got their heads out of their bums, the stock would trade up $3-5 on this expectation alone...

    Stocks: AMRN
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  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    So that would mean Anchor is a done deal which was never in doubt. Wonder what the timing of this is...
    20 Jul 2013, 10:26 AM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    No way they pay off the loan. The would make them look totally clueless. They already said what the recent offer was for as it is in the 8k. This mgmt under reliant went alone till revenue was 175mill or so with Lovaza. I am prepared for them to do the same. This mgmt will just build sales till they get what they want. I just hope they dont wait till Decemeber to decide what to do while stringing us along like last year. They need to partner up next 2 months and not in November or December.
    20 Jul 2013, 07:29 PM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    I don't see amrn mngt waiting that long. You can't compare how long they waited with Lovaza bc Lovaza only had access to Marine a much smaller market. They could have done whatever the wanted since the space was so small.

     

    In the Anchor space its a different story. AMRN will need the help to launch in that market and they don't have much more time to waste. Either that or a much bigger sales force and in order to raise more money to hire that many reps this companies mkt cap needs to get back to at least $2 Bill and stock in mid teens or higher. Other wise they would destroy the company and the stock with diluting it again anywhere under $10-$13...

     

    On a separate note what many people don't know is that the main reason they waited so ling to do the deal with Relaint and GSK for Lovaza was bc they ORIGINALLY tried to do a deal with PFE but it fell through. The first plan was to try and combine Lovaza and Lipitor but bc of Lovaza's s/e's (raising LDL) it failed. So the deal with PFE failed.
    Then although GSK couldn't combine Lovaza with their Statin either they still figured they could just add Lovaza to their pipe as another drug on it's own and since Lovaza was the First approved Trig drug they had no competition to worry about.
    That as well as Lovaza having NCE is why GSK paid $1.7 Bill for a drug with little sales.

     

    Now look at the entire picture with AMRN and Vascepa. At minimum AMRN is worth $4 Bill when their mkt will be 10x's bigger and Vascepa will be 1st in class just like Lovaza.
    However, Vascepa is 1st in class for 40 mill and Lovaza was 1st in class for 4 mill...

     

    A deal of this size takes time. And with BP it's not about "is AMRN worth the $"... It's about BP having all the ducks in a row with AMRN b4 they sign a $4,$5 Bill+ check.
    But both Big Pharma and AMRN would be STUPID to not be partnered up before the drug launches in the Anchor market.
    22 Jul 2013, 02:13 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (109) | Send Message
     
    They already look totally clueless. Taking on the debt with less than favorable terms and THEN diluting near the 52 week low doesn't exactly look brilliant. 8ks can be issued like toilet paper. Big deal. I'm reaching into thin air to try and explain the unexplainable, lol.

     

    "I just hope they dont wait till Decemeber to decide what to do while stringing us along like last year. They need to partner up next 2 months and not in November or December."

     

    ON THAT.........we definitely agree !!!
    20 Jul 2013, 08:03 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (68) | Send Message
     
    The chances of ANCHOR approval by Dec are very high, above 90% or even more, in my opinion. Personally, I'm not worried about it.

     

    But I think that's not the question.

     

    The question here is when ANCHOR is approved , management could not launch the product to the market because financial needs would be very high for a medium pharma like AMRN.
    Company hired 275 representative sales for MARINE.
    The ANCHOR needs are far greater. A lot of people think that management will execute another secundary by then. I don't think so. That secundary would be ... huge. I don't see another secundary.

     

    The only way is partnership or buy out.

     

    I think that Big Pharmas are interested, very interested.
    BUT they know that AMRN cannot going into alone with ANCHOR (it would be a waste) and I think BP can play that game and forces to AMRN to less profitable agreement than management wants and we are expecting.

     

    Why is Wall Street so quiet?
    Well, I have a said "maximum depreciation until the last moment".
    I also think that big funds and institutionals are waiting for any kind of signal from Big Pharma. Wall Street needs guarantees and make sure that AMRN will not die because its awesome succesa.

     

    Said all this, I am very long.
    21 Jul 2013, 10:48 AM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Exactly. Another secondary with AMRN mkt and stock under $2 bill would be too big. It would destroy and dilute too much. That is if the SEC even approved it.
    They would need at least a $300 mill+ raise min to hire the necessary s/f for anchor and AMRN is not goingt o do that with the company worth $1-$1.5 Bill.. It's not logical or capable.

     

    So at this stage AMRN either needs to STEP up and find a way to get the stock back to $16-$18 or higher and mkt cap to $2 bill or more, before they even consider another secondary.. OR partner/sell the company before year end or Anchor PDUFA...

     

    It doesn't take a Harvard grad to see this.. So yes I agree the company needs to SPEAK UP and Start defending itself so the stock can get some true value to it. Because it has no biz trading down here and the longer they allow WS to beat up their stock, the tougher their road ahead will be, no matter how great they continue to execute..
    22 Jul 2013, 02:23 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (68) | Send Message
     
    yeah, I'm with you.

     

    Another point.
    All we know that the current price is ridiculous and it's been manipulated by hedge funds.
    But at this price, why are not we seeing insiders buying tons of shares?
    That concerns me.
    23 Jul 2013, 04:09 PM Reply Like
  • xtramieinvest
    , contributor
    Comments (74) | Send Message
     
    its so hard to understand why so many people cant see, how valuable the product is and especially the potential market..i appreciate your comment,,, as a young trader...I just cant seem to understand that the bashers,, shorts,, and ws can have such a depreciation on a pps on a stock... Ive done my dd and understand that after anchor and reduce it.. the world needs vascepa,, long and strong, adding shares at this unbelievable price.. amrn,, arna.
    23 Jul 2013, 08:58 PM Reply Like
  • Jolk
    , contributor
    Comments (230) | Send Message
     
    Insiders can't buy for a period of time after dilution, it is all in the SEC filing. They also have certain periods of time where they are allowed to buy on the open market.
    25 Jul 2013, 08:24 AM Reply Like
  • Anaramos
    , contributor
    Comments (5) | Send Message
     
    I think this data are already included in the labelling:

     

    "Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    Adverse reactions reported in at least 2% and at a greater ra
    te than placebo for patients treated with VASCEPA based on pooled data across two clinical studies are listed in Table 1."
    21 Jul 2013, 11:12 AM Reply Like
  • Anaramos
    , contributor
    Comments (5) | Send Message
     
    According to this clinical review <http://1.usa.gov/12YUA6w; the JELIS information could be included:

     

    The applicant is relying on non-clinical literature references for the marketed Japanese product Epadel to support this application
    "ethyl EPA has been investigated in large study in Japan.

     

    Ethyl EPA has been marketed under the name Epadel Capsules (sponsor: Mochida) in Japan since 1991.

     

    The Effects of eicosapentaenoic acid on major coronary events
    in hypercholesterolaemic patients (JELIS): a randomized open-la
    bel, blinded endpointanalysis, 18,645 Japanese patients were randomly assigned to either 1800 mg of EPA plus a statin or statin alone.

     

    According to the pharmacology/toxicology reviewer, there's a reasonable evidence to conclude that Vascepa is highly similar to the marketed ethyl-EPA product Epadel for the following points:
    - source of ethyl-Epa before purification is fish.
    - Specification for purity of ethyl-epa are identical (>96%)
    - The impurities for each product are similar, but not identical; however, the concentration limits for this are generally low intemediates in x metabolism are part of the complex mixture of x

     

    Based upon scientific evidence of similar toxicologic profiles, similar (not identical) chemical profiles of highly purified icosapent-ethyl, and the well understood pharmacology of polyunsaturated fatty acids, it would be reasonable to conclude that Epadel and Vascepa are similar products.
    However, from a regulatory perspective, Amarin Pharma has not conclusively demonstrated direct comparability between Epadel and Vascepa due to the absence of any direct bridging study conducted by Amarin Pharma or an acceptable PK comparison to the literature references. Therefore the 74-day letter was sent to the applicant with the following statement:
    “As there is no adequate bridging information to Epadel, conduct an appropriate non-clinical study (e.g. 28-Day repeat dose toxicology study in the rat) to demonstrate at a minimum, PK comparability between Epadel and Vascepa (AMR101), so that you may rely on published Epadel literature for your 505(b)(2) application.”
    In their response, the applicant agreed to conduct a nonclinical study to bridge the information for Epadel to Vascepa. Subsequently, the applicant submitted a completed 4-Week rat study entitled “A 4 Week Study of AMR101 and Epadel by Oral Gavage Administration in Rats” on 17 May 2012. The pharmacology/toxicology team concluded that this study demonstrated an adequate bridge between Epadel
    and Vascepa.
    21 Jul 2013, 11:13 AM Reply Like
  • ReallyReal
    , contributor
    Comments (5) | Send Message
     
    It would be nice to get some really good news at the CC but seems unlikely at this time. The CEO said he needed two full quarters to give any guidance. We have one more full quarter to go before that happens. They just raised a pile of cash to further their marketing efforts to continue going it alone. What else are they going to say, maybe something lame like, "We can now use ANCHOR data in our sales". The market already knows that and has priced it in.
    21 Jul 2013, 11:29 AM Reply Like
  • Anaramos
    , contributor
    Comments (5) | Send Message
     
    "Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    Adverse reactions reported in at least 2% and at a greater ra
    te than placebo for patients treated with VASCEPA based on pooled data across two clinical studies are listed in Table 1."
    21 Jul 2013, 11:42 AM Reply Like
  • Samuel-
    , contributor
    Comments (103) | Send Message
     
    I guess its business as usual again for the stock.. price is down to 5.30$ over nothing, you know, just the casual daily 2% drop
    23 Jul 2013, 04:21 PM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    Supposedly, JPM has dropped price target to $12 from $16. I guess I cannot blame them for being realistic versus being delusional.

     

    This stock is going in the wrong direction. I'm expecting low $4's by the end of 2nd qtr conference call. Management will stonewall Wall Street and act the arrogant part. Scripts have been in the range of 4k to 4.5k over the past 5 weeks. In other words, no growth. And there are still a lot of investors who still believe in the pie-in-the-sky numbers.
    24 Jul 2013, 02:51 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (68) | Send Message
     
    Maiwat,
    I think JPM is including secundary in its valuation (dilution effect).
    And they won't take in consideration ANCHOR until it's approved.
    They are very conservative.

     

    But even at $12 , AMRN is still very undervalued.
    24 Jul 2013, 09:09 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » the JPM price change is no surprise, it reflects the fund raise.

     

    it only factors in self launch of marine, no anchor fully built in.
    24 Jul 2013, 08:54 AM Reply Like
  • Maiwat
    , contributor
    Comments (30) | Send Message
     
    Until management pulls its head out of its rear-end, I feel Wall Street is expecting a GIA for Anchor. Investors will see JoeZ play the same game he played a year ago. The company will wait 4 or 5 months after Anchor approval (assuming it is approved), it'll tell us it has 3 paths and then it will conclude that GIA is the path.

     

    Management could be proactive and put the pieces in place now, but that will never happen. It's too much fun watching the price per share drop 1%-2% every day.

     

    Guaranteed, management will NOT give any guidance on the 2nd Qtr conference call, they WILL give us the 3 paths and they will tell us that there is nothing else they can say.
    24 Jul 2013, 11:12 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (68) | Send Message
     
    From the JPM note today:
    "...Recent offering should provide sufficient capital for an ANCHOR launch. "

     

    What?
    I totally disagree with this statement.
    24 Jul 2013, 03:26 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (785) | Send Message
     
    Author’s reply » just wait until anchor...
    24 Jul 2013, 08:16 PM Reply Like
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