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  • Where Is Amarin Really? 15 comments
    May 15, 2013 12:12 PM | about stocks: AMRN

    I have been following AMRN and have been involved in the Company since May 2010 and I wanted to fully breakdown the "REAL" picture of Amarin and it's stock.

    Back in 2010 Amarin as a company didn't have much. The Company only had 1 drug AMR-101 and it was still in trials. In November 2010 Amarin announced positive Phase 3 Marine SPA Trial Data causing AMRN stock to jump to the $6 level (a double from where stock was previous). Over the next few months the stock traded between the levels of $6-$8 per share before Institutions got involved through a Private offering with Amarin in January 2011 in the $7 stock range.

    In April of 2011 Amarin then released more positive Phase 3 SPA data for the ANCHOR Indication (a 10x's larger market). That news caused AMRN stock to double again and open at $15 per share.

    The reason I bring this all to the surface is simple. AMRN at that time had NOTHING in terms of an FDA approved drug, NO Insurance Coverage, NO Patent Coverage and No suppliers. Now let's take a look at what milestones Amarin has accomplished until now....

    - Vascepa FDA approval for Marine Indication

    - 22 Patents Issued and Allowed

    - 4 Top Suppliers & Manufacturers to produce and ship Vascepa

    - Tier 2 Insurance after only 2 months of drug launch

    - Early sNDA Acceptance ANCHOR Market & PDUFA Dec 20, 2013

    - 100% Month to Month Script Growth (Done by themselves)

    - ONLY Omega-3 Drug to Treat ANCHOR Market

    - ONLY Omega-3 Drug that can Combine with a Statin

    This company continues to come out with positive news, and whether Evidence Based Proven Data that shows Vascepa is a superior drug in a class and market of it's own or the 22 Patents which is 10 times more then their competitor Lovaza that only has 3 Patents, yet there is a constant attack on Amarin.

    In my opinion there are many key milestones that have been accomplished in 2013 alone (Launch, Patents, Tier 2, etc.) that have NOT been valued into AMRN's stock price. If you look at the whole picture Amarin's stock is trading at the same level it was back in 2010 when they announced the Marine Data. At that time Amarin had NO FDA approved drug, No Patents, No Insurance and NO data and sNDA acceptance for ANCHOR, so how can Wall Street and certain investors, journalists etc., really value this company down here?

    Not to mention the Big Name and More Reputable Institutions like Jefferies, JP Morgan, Leerink Swan, Canaccord and Citi have Price Targets from $13-$39, with an average PT of $17.65 however, these go overlooked and pushed to the side.

    In conclusion you can make all the speculation you want around NCE, but with the Patent Portfolio that AMRN has built up and the FACT that Vascepa will be the 1st ever drug to enter the ANCHOR Market, NCE clearly does not justify why AMRN should be trading at the $7-$8 range. In my opinion AMRN is very undervalued at this level and hopefully the continued week to week and month to month script growth as well as the upcoming Combo-Statin Data will help get AMRN stock to a level of true valuation before the drug Launches in the ANCHOR Market and/or Partners up with a Big Pharma.

    Stocks: AMRN
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Comments (15)
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  • Ladavis23
    , contributor
    Comments (13) | Send Message
     
    Good overview, all great points. You reference the previous milestones with the stock with NO approved drug, patents, etc etc at the time and compare to where we are now having achieved all these incredible milestones. The disconnect seems to feel that at the time in 2010 and 2011 per your reference the belief was that AMRN would never sell Vascepa on their own, that a buyout would take place prior to any launch. Like you, I have been involved with AMRN early. The buyout dance has been going on for many years. Now here we are, launching on our own, and having to deal with all of the challenges that come with a solo launch. Is NCE clarification the hold up? Is it something else? How do you feel about JZ's comments on the most recent cc regarding 3rd party for Anchor? I feel he has again played into his weakness on delivering his message to investors. Why tell WS over and over you are for sale, or looking for partner? Why not sell the street that AMRN is full blown GIA, preparing to make billions, and show that confidence? It just seems that while he has been on point with business milestones, he still is off when it comes to investor relations.
    15 May 2013, 03:59 PM Reply Like
  • krhumble
    , contributor
    Comment (1) | Send Message
     
    Hi Harvey, or should I say Key2Success. Used to communicate with you on StockTwits. You knew me as Washpa. Currently hold 5,450 shares of AMRN and will hold till Co goes "big" or gets bought out. Your article certainly provides great info, re: what Amarin has done with Vascepa.
    15 May 2013, 03:59 PM Reply Like
  • sts66
    , contributor
    Comments (1861) | Send Message
     
    "Early sNDA Acceptance ANCHOR Market & PDUFA Dec 20, 2013"

     

    Wasn't early, was almost exactly on time.

     

    "100% Month to Month Script Growth (Done by themselves)"

     

    Wrong again. Nowhere close to doubling srcrips mo/mo.

     

    "ONLY Omega-3 Drug to Treat ANCHOR Market"

     

    True, but ANCHOR not approved yet, irrelevant right now.

     

    "ONLY Omega-3 Drug that can Combine with a Statin"

     

    That's your worst one of all - on what basis do you make this claim? Sure, AMRN is filing patents of V in combo with statins, but that certainly doesn't preclude Lovaza from being prescribed along with a statin. Perhaps you meant the V + statin appears to provide synergistic effects great than either one alone?

     

    I'm long AMRN, folks on SA know that, but this article is pretty much useless for DD to newcomers....
    15 May 2013, 08:17 PM Reply Like
  • Jolk
    , contributor
    Comments (258) | Send Message
     
    Perhaps he meant that Lovaza and Statin failed their trial.
    17 May 2013, 09:32 PM Reply Like
  • sts66
    , contributor
    Comments (1861) | Send Message
     
    Which trial are you referring to? Only one I found was the COMBOS study, which while not having what I'd call stellar results compared to Vascepa + statin, certainly appears to have had some positive benefits (no change in CRP though). Below is link to the Google cache of that study's summary on Medscape, only way to read it unless you have a subscription to the site:

     

    http://bit.ly/188xRd3;rls={moz%3Adistributi...
    18 May 2013, 04:58 PM Reply Like
  • Jolk
    , contributor
    Comments (258) | Send Message
     
    The trial that would have given them approval to sell/market to the ANCHOR population. FDA denied them approval.
    18 May 2013, 05:50 PM Reply Like
  • sts66
    , contributor
    Comments (1861) | Send Message
     
    ANCHOR indication/label expansion is for patients with T's 200 to 500, really has nothing to do with statins, except indirectly - in that population V can be used with or without a statin to reduce T levels w/o raising LDL. Can you find the trial or sNDA Reliant or GSK filed with the FDA that got rejected? Would like to see the results they got to compare them to V's results - I've not previously heard that anyone tried to get Lovaza marketing approval for the ANCHOR population.
    19 May 2013, 01:25 PM Reply Like
  • Jolk
    , contributor
    Comments (258) | Send Message
     
    From Reliant's IPO filing:
    "We completed a study with adult patients currently taking simvastatin and at or near LDL-C treatment goal who then added treatment with Lovaza. The results of this study directed at the requirements agreed upon with the FDA following receipt of the Approvable Letter, were submitted to the agency. On June 12, 2007, the FDA issued us an Approval Letter permitting the addition of select study data within the clinical studies section of the label for Lovaza, but did not approve the additional indication for Lovaza that we sought."
    19 May 2013, 01:52 PM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Author’s reply » Vascepa has NOT been denied any approval..
    20 May 2013, 04:31 PM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Author’s reply » Script growth has been 100% by themselves.. AMRN has NO partner with Big Pharma, they launched on their own... FACT!!!

     

    Anchor done under a SPA and will be approved, and IS VERY RELEVANT right now to BIG PHARMA.. 10x's bigger market where Vascepa will be the only drug, you bet 100% that it's very rellevant right now!!!

     

    sNDA for ANCHOR was early.. "almost exactly on time" IS NOT ON-TIME... THAT'S EARLY...

     

    Seems like your long a stock and a compnay you really don't know or understand...
    20 May 2013, 04:31 PM Reply Like
  • Jolk
    , contributor
    Comments (258) | Send Message
     
    If you are addressing my comments, I know, I was referring to Lovaza and saying that they were not approved for the ANCHOR population 200-499mg/dL.
    20 May 2013, 05:40 PM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Author’s reply » Ok. Sorry about that!!
    21 May 2013, 04:15 PM Reply Like
  • isaeed
    , contributor
    Comments (2) | Send Message
     
    sts66, sNDA acceptance date was to be approx. 74 days from date of submission. It came 2 weeks earlier. Thus it was not on exactly on time. And lets not forget, no Adcom for Anchor. Direct PDUFA.

     

    100% month to month is also partially correct. Here are parts of the transcript from the cc: '.... On the Vascepa sales side, in the three months since launch, February and March which were part of the first quarter and April part of the second quarter which we can report today, we recorded 3200, 7200, 11,800 prescriptions normalized TRXs approximately. This brings the total number of prescriptions to well over 22,000..' . From launch prescriptions have gone 100% of the initial month every month.
    16 May 2013, 02:43 AM Reply Like
  • sts66
    , contributor
    Comments (1861) | Send Message
     
    Official FDA rules say sNDA/NDA acceptance or rejection within 60 days: "After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed." [from http://1.usa.gov/16mgA2Q]

     

    But then there's this contradictory "74 day letter" stuff from a different FDA website:

     

    http://1.usa.gov/13pIx2w.

     

    "FDA evaluates the application within the first 60 days of its receipt to determine if it is sufficiently complete to conduct a full review. If FDA determines that the application can be filed (i.e., the application is sufficiently complete), the application review continues. Under PDUFA III, FDA agreed to communicate to applicants any significant review deficiencies identified during the filing review by day 74 of the review cycle."

     

    My readings of this issue is that they have 14 days to initially identify deficiencies in the NDA, which could mean 74 days total, but if none are found it's typically just 60 days.

     

    "From launch prescriptions have gone 100% of the initial month every month."

     

    If that's something said during the CC, somebody needs to go back to school and learn some basic math - scrips going from 7200 to 11,800 is a delta of 4600, or 64%, not even close to 100%.
    16 May 2013, 03:48 PM Reply Like
  • Life-Science
    , contributor
    Comments (50) | Send Message
     
    Author’s reply » The bottom line is Amarin is a 1 drug company that has grown from $137 Mill Market Cap in early 2010 to roughly $1.7 Bill when Vascepa was approved and now is currently slightly over $1 Bill..
    For a 1 DRUG company that launched on their own and has acquired 22 Patents (issued or allowed) & Tier 2 Insurance, as well as hitting EVERY other Milestone, Amarin is solid as can be.

     

    The problem is many people are trying to judge AMRN because of where the stock is trading and NOT what the company is accomplishing as well as the FACTS.. Then they try to find any bit of speculation (NOT FACT but OPINION) to justify it.

     

    I won't go back and forth with those that don't understand "everything". Yes that means Amarin, Vascepa, Joe Z, The ENTIRE LIPID Space, The FDA and Lovaza.. ALL of it..

     

    This stock made 2 huge runs early on and if you missed those runs "oh well", but just because many did doesn't mean AMRN isn't doing what it needs to do..

     

    On the last note AMRN may be a 1 drug company however, that 1 drug "VASCEPA" is entering several markets!

     

    Marine - $4-$6 Bill
    ANCHOR - $40-$50 Bill
    Combo-Statin - $26 Bill a year
    150-199mg - $30 Bill
    Down the Road - Diabetes, Inflammation & remain Cardiovascular diseases

     

    This is a Primary Care drug that is ULTRA-PURE with a very low side effect profile so whether people want to think it's relevant now or not "all of these markets are"... Starting 2014 with Vascepa entering ANCHOR their market will increase to over $50 Bill...

     

    Lovaza captured 15% of their mkt and did $1 Bill in Sales.. If Vascepa captures ONLY 2% of their market they still do roughly $1 Bill in sales..

     

    Whether your long or short AMRN, if you bash this company or you don't know all the facts, something is VERY WRONG!!!
    20 May 2013, 04:31 PM Reply Like
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