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Gary Head

 
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  • Amarin: REDUCE-IT And Debt Analysis Confirm That The Current Share Price Is An Opportunity [View article]
    Biwatch
    A closer look at your income projections
    End of first Qt 2016 ( when we expect interim data analysis ) you are projecting 17,900 weekly scripts and ending the Qt with 21m cash on hand .

    I expect more push back by insurance companies ...note STS 's posts on IHUB re his insurance co increasing the copay in 2015 , increased competition if AZN successfully launches Epanova and 0 sales in 2016 for those with no insurance if Amarin stops their coupon plan ( stated to end Dec 2015 )

    So the question for me ( and I suspect WS ) ...is, even if we believe Vascepa will show benefit , how certain are we that Amarin will make it to Interim without the need to raise some cash , partner to cover cost of RI etc

    Gary
    Oct 9, 2014. 02:06 PM | 1 Like Like |Link to Comment
  • Amarin: REDUCE-IT And Debt Analysis Confirm That The Current Share Price Is An Opportunity [View article]
    Biwatch
    Great to see an in depth analysis.
    I only had time for a quick scan but would comment the following .

    1) if Vascepa only reduces risk by 15% I expect it to be largely ignored ( You get about the same risk reduction by giving up processed meats , Bacon etc )

    2) We still need generous insurance co pays to ensure sales of Vascepa
    Few want to pay $5.20 a daily 4 gm dose now ( Using Amarins coupon but no insurance coverage ) and practically no one will pay $7.20 a day without insurance when Amarin coupon plan expires Dec 2015.

    Perhaps you could comment on the threat from AZN's Omthera ...if they overcome Amarins claim of patent infringement and launch in 2015 , that may seriously damage your projected sales of Vascepa . AZN is a force not to be ignored on multiple levels ( sales force numbers , sales budget , Dr Nissen etc etc ).

    I agree with your view on Reduce It but less so on cash/sales going forward
    Great to read an indepth analysis.
    Thanks
    Gary ( Kiwi )
    Oct 9, 2014. 11:57 AM | 3 Likes Like |Link to Comment
  • The FDA Oil Tanker Will Not Be U-Turned And Amarin Corporation Faces Collateral Damage [View article]
    Curve
    IMHO the basis of your article is suspect .

    For example ...the links you refer to re the wash out period
    1st study had 12 men , 2nd 58 men , 3rd 20 participants ...these studies are not large enough to have high confidence in the results
    Take the first study ...12 men ...just flip a coin 12 times and it comes up tails 8 times ...does that give you high confidence that if you flip a coin 1200 times ( the size of the Anchor trial ) you will get the same result % wise ...ie 800 tails
    Of course not .
    Dr Ballantyne ( Anchor ) probably knows more about washout periods and placebos , then you seem to give him credit for .

    Regarding the NEJM articles and APOC3 ...this is relevant ...this is new important information that you dismiss. You seem to dismiss it even though Dr Nissen ( Cleveland Clinic ) is on record as saying these findings increase the chances that his STRENGTH trial and Amarins REDUCE IT trial will show benefit .
    In addition , many Cardiologist now acknowledge for the first time that high triglycerides are more relevant then HDL cholesterol in assessing CV risk .
    This is a different environment then what existed at the time of Adcom.

    Nor do you address the fact that over 30,000 patients ( Scripts plus Reduce it ) have been on Vascepa for over a year now with no reports of serious bleeding ..a chief concern of Dr Hiatts I believe at Adcom . This issue should now be some what alleviated .

    I agree that we probably wont see the SPA reinstated but I think there is a very good chance that the results of the Anchor trial will be included in the prescribing information along with the statement " Not proven to reduce CV events ..awaiting outcome data from Reduce It "

    And finally ..and most importantly ...the line " Manuscript with a mission , chronicle with a cause "...original or lifted :)
    Gary
    Sep 11, 2014. 08:52 PM | 1 Like Like |Link to Comment
  • The FDA Oil Tanker Will Not Be U-Turned And Amarin Corporation Faces Collateral Damage [View article]
    Curve
    Re your statement " If AMRN had a treatment to knock down APOC3 etc "

    My understanding is the Vascepa in 4 gm doses lowers APOC3 by 20% and 25% with max Statin
    Gary
    Sep 11, 2014. 08:05 PM | Likes Like |Link to Comment
  • Amarin: Starting To Show Some Modest Vascepa Growth [View article]
    Elephant
    Well Yahoo is not carrying Seeking Alpha any longer so your article will probably be read by far fewer then in the past ...which is unfortunate.

    I think the chances of the SPA being reinstated and at least some negotiated expanded label to include those at most risk ( diabetics , dialysis patients etc ), have greatly improved since the New England Journal of Med articles on the role of high TG's and APOC3 , in CAD..

    So I would rate some form of expanded label as being more likely then you are calculating . If that occurs then Script numbers will be a lot higher then you project .

    On the flip side ...if an expanded label is not negotiated then I expect Amarin to have less then $100 m cash on hand at yr end and without drastic cuts , to be out of $ by mid 2016 .
    You might note that their Bio Pharma loan is in effect being converted into a loan at the estimated compounded interest rate of approx 12-14% from 8K filed 12/12/12.

    As a current holder of AMRN stock and call options , we need an expanded label OR early positive Reduce it results .
    I'm hopefully on both
    Gary
    Aug 4, 2014. 09:07 PM | Likes Like |Link to Comment
  • Celladon Lock-Up Expiration Could Be A Short Opportunity For Aggressive Investors [View article]
    So how's your short position working out Don ..or did you cover at $10.50 ?
    Gary
    Jul 21, 2014. 01:20 PM | 1 Like Like |Link to Comment
  • Celladon Lock-Up Expiration Could Be A Short Opportunity For Aggressive Investors [View article]
    Well Don ..a few days late ...maybe next time co ordinate with Yellen .
    Re the competitors you mentioned ..care to identify where they are in their clinical trials ?
    Heart failure is serious ...from memory, life expectancy for those hospitalized for heart failure ...50% make it 5yrs .
    Re insiders selling ...well we can look to PCYC for that ...that presented the last great buying opportunity before their climb .
    Gary
    Jul 16, 2014. 11:29 PM | 2 Likes Like |Link to Comment
  • Basket Of Biotech Bargains To Buy And Hold [View article]
    Intrepid
    A reply to your reply
    The investment potential for AMRN is not in capturing the very high TG market ( TG's over 500 ) ...IMHO ...its in gaining wider approval for those with Cardiovascular risk with TG's between 200-500.

    Name 1 drug other then Statins that has been proven to lower CV events in an Outcome trial. So forget Fibrates ( Accord trial ) Niacin ( Thrive trial ) and regular fish oils or Lovaza.

    Even looking at Statins ...look at the Jupiter trial with Crestor ...that trial was more about lowering hsCRP ( inflammation ) then about lowering LDL.
    Vascepa lowers hs CRP by about 22% ( going from memory ) as well as lowering TG's and also slightly lowers LDL .....so its lowering multiple surrogate risk markers associated with CV risk

    The long term question for AMRN is whether or not they can get a positive read out on their current Reduce It outcome trial before they run out of cash ...note Biwatch's article in SA.
    Note ...even Dr Nissen ( Cleveland Clinic ) has been quoted as saying that the recent NEJM reports on APOC3 and TG's increases the chances of success for Reduce It
    In the short term the FDA has to respond to numerous Citizen Petitions protesting the AMRN adcom hearing and the rescinding of AMRN's SPA.
    Gary
    PS ...nice wave you are dropping into ..profile photo ...go big or go home :)
    PPS ...Vascepa is the easiest ( patient friendly ) lipid altering drug I've ever taken ...and I've taken them all except Lovaza , usually at max dose ( hetero FH )
    Jul 1, 2014. 12:36 PM | 1 Like Like |Link to Comment
  • Amarin Scrapes The Bottom Of The Barrel [View article]
    Right Louielouie

    Commenting on this new research

    " Based on our findings , we predict that lowering TG's specifically through the inhibition of APOC3 would have a beneficial effect by lowering disease risk "...Prof Reiner .
    Similar comments from Dr Kathiresan

    Commenting on the studies
    " very strong type of evidence that TG's are in fact a cause of heart attacks "-Dr Hegele.

    Even Dr Nissen ..Cleveland Clinic has been quoted as saying that this research increases the chance of a successful outcome for the Reduce it trial

    If the event lines in Amarins Reduce It trial diverge by at least 25% ...showing clinical benefit from 4gms of vascepa ...over the next year 18 months ...chances are Reduce it will be stopped for efficacy well before 2017.

    The recent NEJM research you cited , increases the chances of that happening.
    Gary
    Jun 27, 2014. 11:29 AM | 5 Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    Ralph
    Altho we are both long , I can also argue the bear case

    When comparing to Jelis ....you are referring to the subgroup that had high TG's as well as low HDL cholesterol ...not simply high TG's

    Second ...The Statins used in Jelis were low dose of medium strength Statins . Many in Reduce It will be on Crestor of Lipitor at doses that may be at least 4 times the strength of what they were taking in Jelis

    The average LDL cholesterol level in Jelis was I think at 177 ...to qualify for Reduce it you have to get your LDL below 100

    Gary
    Jun 12, 2014. 01:15 PM | Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    RHM
    AMRN is not dead until Reduce It fails .
    Name one other drug added to Statin treatment thats proven to reduce CV events in a US population .
    If Vascepa does it will be the first that I know of .
    Gary
    Jun 12, 2014. 01:08 PM | 4 Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    Big Alpha
    IMHO at roughly $1.60 a share you are buying an option on an early positive read out on the Reduce It trial .
    No one is interested in waiting to 2017 for completion of this trial ...we want it stopped for efficacy well before then ...in fact before the end of the 1st Qt 2016 ..when I estimate that will have burn't thru their cash on hand.

    As long as the Bio Pharma deal allows them to pay on a % of revenue instead of a fixed qtly amount , and KOWA provides some lift in sales by year end ( so they don't actually loose $ on their sales force ) they can make it to early 2016.

    So the real question then is ...What are the chances of Reduce It being stopped before they run out of $.
    For those interested I recommend the Seeking Alpha article by Biwatch.
    Gary
    Jun 12, 2014. 11:09 AM | 3 Likes Like |Link to Comment
  • Amarin Is Likely Now A Vortex Where Your Money Will Go To Die [View article]
    Quoth
    I would be interested in your view of the SA article written by Biwatch Dec16 2013
    " Amarin Todays market is underestimating the probable success of Reduce It "

    Reduce It interim data analysis is likely early 2016 . As long as Amarin keeps Reduce it going and doesn't burn through their cash until then , its a little premature to concede defeat
    Gary
    Feb 26, 2014. 02:40 PM | 5 Likes Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    Quoth
    The smart money is betting that the FDA will expand the label to include at least those with a combination of high TG's and low HDL despite Statin therapy .
    Suggest you read the Clinician /Scientist SA article on it posted earlier and visit the EPAdruginitiative site
    Gary
    Dec 20, 2013. 11:26 AM | 4 Likes Like |Link to Comment
  • Amarin: Today's Market Is Underestimating The Probable Success Of REDUCE-IT [View article]
    Biwatch
    Thanks for the article on Reduce it .
    Lets hope they can fund it to at least interim data.
    Gary
    Dec 16, 2013. 04:46 PM | 1 Like Like |Link to Comment
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