Amarin Corp PLC (AMRN) Quote

Exactly Rosem....... I also remember one of the Adcom doctors commenting that he was worried that this would become cardio candy...... to me, that's a comment that smells like he was afraid too many prescriptions would be given out. I mean, that's the whole point. The evidence was too strong not too vote for and it was 16-0. He was probably Nissen's secret lover..... who knows!

Ram, you are definitely correct about that. I believe that Kiwi though has mentioned easier things like some RWE that insurers might already have from people being on V for a number of years now.

All those statin studies were not done by one company. The FDA vigorously defended R-I at the Adcom, and although It is my opinion that there is sufficient corroborating evidence for V (Jelis, Respect?, Evaporate, etc) what is the point of a p value if studies have to be redone a myriad of times.

311 shares moves it up $.08 in PM. Just insane this stock is!

Well Kiwi, let me help set your expectation properly.......you are not going to see another independent study like Reduce-It using V so that more cardiologists will become convinced. Not happening unless you can convince someone to do it. AMRN has no incentive to spend that kind of money again.

Well the quick answer is that those EU health depts that wasted tax euros reimbursing a drug with no CV benefit ( Omacor /Lovaza ) came under a lot of criticism .
So many now want independent confirming data
Kiwi

Ram Why do I have problem with the buyback . Short term its a win , long term a waste of $
So my plan is to accumulate under $1 ...if the buyback pushes the PPS over $1.50 ...I"ll sell ( 50% return ) unless I see them making concrete plans to increase the level of evidence that Germany and France will likely want before reimbursing.
Why risk a trial ( even a small one in a select subgroup ) and risk a different result ...because without that independent trial many in the Cardiology community remain unconvinced.
There were at least 13 independent trials confirming risk reduction of Statins
At least 3 for PCSK9's ...
Germany has always wanted independent placebo controlled trials before reimbursing CV drugs ...at least in recent years . If you aware of a CV drug reimbursed in Germany based on 1 double blinded trial , please post it
Kiwi

Your are making my point that if they were enamored with Gissi-Prevenzione, then they should over the top with R-I. Gissi was an open labelled study with no measurement of Omega-3 of participants. Many other facets too. No comparison to R-I.

So Kiwi, since you acknowledged a share buyback will most likely cause the PPS to rise, why do you have a problem with that? All longs in this stock are in the stock for the PPS to rise. You discount the fact that this management team may actually know what they are doing. AND, Your fantasy of AMRN doing another placebo controlled double blind study is never coming to fruition. Why would they do do that and risk a different result when they already received the desired indication?

RMB. I think it was this trial. The results of the GISSI-Prevenzione trial in the general framework of secondary prevention that started the whole love affaire with Lovaza / Omacor .
Results weren't independently confirmed in at least Dr Nissens trial with EPA/DHA and probably others beforehand.

Trick is indépendant confirmation of results ...preferably by another double blinded placebo controlled trial of at least a sub group of the initial trial .
Kiwi

Interesting that those EU countries reimbursed handsomely for Lovaza/Omacor, then stopped doing so and now with Vazkepa although not as effective at lowering trigs, nonetheless lowers trigs, doesn’t raise LDL, and have proof of reducing CVD (something Lovaza never has shown), they are so residtant to reimbursing. You would think they would be falling over themselves to cover V.

Tat, The appellate court can only make a determination about the the ruling from the district court. Was that ruling correct based on the relevant law? The practices of insurance companies don't meet the legal definition of direct infringement. It is inducement.
Sleven,

So here's an example of what these AMRN guys / girls are getting

Explanation of Responses:
1. On April 18, 2024, following the conclusion of the Issuer's annual general meeting of shareholders for 2024, the Reporting Person was granted an option to purchase 179,795 Ordinary Shares under the Plan and the Policy. The shares subject to this option shall vest and become exercisable over three years, with 33% to vest on the first anniversary of the grant date and the remaining balance vesting in equal quarterly installments over the subsequent two years on the first day of each April, July, October and January.

So hey ...how can we get the PPS up so we can cash out next April .
Well for starters ...lets do a share buyback

Kiwi

$AMRN Two easy steps in the ESC 2021 Guidelines for significantly reducing residual CVD risk in all European regions includes icosapent ethyl (VAZKEPA®). Come on France, Germany, and Italy, get with the program!

https://academic.oup.com/eurjpc/article/31/6/754/7602450?login=false&utm_source=etoc&utm_campaign=eurjpc&utm_medium=email

RE your view
Do you think Reduce It would even exist today if FDA had not mandated it? What would Amarin have to sell if they didnt?
You don't know that AMRN would never have run a CV outcome trial .

They may have on their own , for select subgroups like revascularisation rates following a PCI
What would they have been selling ....an alternative to Lovaza ...which labelled as Omacor had been selling pretty well in the EU

Kiwi

Re Everyone makes money off Amarin except the shares holders. Well no . Some shareholders in the past made significant $ . Some here may remember Biochia ...sold everything early 2020 . JL did pretty well also ..selling down before the Judge Du decision .
Anyone buying under $1 now has a reasonable chance of making some $ .
Why ?
Well as you pointed out ....the biggest beneficiaries of the share buyback are all the AMRN insiders who were recently granted a ton of options and RSU's .
Buying back stock should raise the PPS allowing them to cash out some of these options when they vest ...we of course will get the crumbs ...well at least those of us buying under $1 .
Not investment advice
Risk only what U can afford to lose
JMO
Kiwi

Nope. High TG's with high LDL was a known risk factor . Lovaza was the go to, to lower high TG's . Problem was it raised LDL levels significantly for some.
HeFH patients such as myself often also have mixed D ( High TG with low HDL ) . I couldn't take Lovaza because my LDL was still around 180mg/dl in max dose Lipitor .
My TG's in the low 200's .
So ...back in the day of the Anchor SPA ...we were waiting for AMR 101 ( now Vascepa ) to be approved for reducing high TG's without raising LDL cholesterol .
I think it was a Co called Reliant that developed Lovaza and sold it to GSK ....this is before we found Lovaza did not reduce CV events .
So if the Anchor indication had been approved ...AMRN would have existed as an alternative for those that couldn't take Lovaza.
Omacor ( Lovaza in the EU ) was big business in many EU countries , especially Spain that reimbursed generously for it .

Kiwi

This is true. If not for the FDA forcing REDUCE-It, Amarin probably doesn’t exist today. And they likely would have sold the company in a fire sale.

ramfan

They already made a deal with a broker I believe it was the last conference they presented at. Since its only 50 million dollars the broker has probably already purchased all the shares in advance IMO Everyone makes money off Amarin except the shares holders

Michael

thanks to the FDA requiring the Reduce It trial before it could get going and Judge Du's ruling

Think about what you just wrote carefully... the only reason you're even here now complaining about how Amarin is being treated over the Reduce It CVD label is because the FDA forced Amarin to run it.

Do you think Reduce It would even exist today if FDA had not mandated it? What would Amarin have to sell if they didnt?

Everything you say rings true. I always thought the action against Health Net was merely to force the insurance company into a settlement so that it would conform, at a minimum, to the practices of the other insurance companies. I don't believe Amarin ever intended to seek damages and certainly didn't want to set some sort of precedent that would affect, and offend, all insurance companies, many of whom Amarin was trying to negotiate with at the time. If I recall right, Health Net's violations were pretty blatant. So Amarin likely got what it sought, a level playing field with generics from that company.

As for the generic bias, you make valid and accurate points. I guess the Amarin case differs from so many other companies, as you know, because its price isn't all that much different from generics and it never got a chance to make money with Vascepa before generics entered the picture, thanks to the FDA requiring the Reduce It trial before it could get going and Judge Du's ruling.

BBI, you know more than you think..........they will carefully execute the buying and we won't know until the shares are actually purchased. I suspect that we won't even know the request was approved until after AMRN acquired some of the shares....it also wouldn't surprise me if an arrangement is already in place with a broker that has been accumulating shares for AMRN in anticipation of them getting this approval.

You should try viewing it thru the lens of how politically popular generic drugs are in the US. There's a reason 85%+ of all Rx in this country are generic. It's by legislative design. This board views it as "poor Amarin vs. vulture generics" cause you're invested in Amarin and your pocket book has personally suffered. The rest of the country views it as "greedy brand drug maker vs. generics that help poor grandma afford for her medicine". Has been all along and the facts dont matter. The appellate court commenting on some nothing disclaimer generics could use like "Not for XYZ indication" on a label should tell you they're gonna give the generics an easy CYA out on this and not cross the skinny label provisions in HW because too many people view it as the only way to ensure cheaper drugs. Besides, the real infringement occurs at the insurance level with preferred tier coverage and mandated substitution and Amarin doesnt have the clout to bite that hand that feeds them. They tried, they settled, and nothing changed.

I agree...judges, especially younger ones, like many human beings, have their eye on the next potential step in their careers...They don't want to make a misstep, that might mitigate against them in the future....This includes possible advancement to a higher position within the court or even to a higher court.

Even on the Supreme Court, it is not unheard of, to have a justice entertain still higher ambitions.

I know nothing about how much buying of a stock it takes to move the price, but I would imagine you'd have to really space out your purchases if you're planning to drop $50 million into a stock. Wouldn't the sudden purchase of so many shares make the share price explode to $6 or higher? I would think you'd have too limit your buys to 200,000 to 300,000 shares a day, tops, to keep the share price down while you carry out purchases. But I've also seen companies announce share buyback plans and never come close to buying as many shares as they pre-announced.

Heading into the daily fade.

The only unfortunate thing is that they need to make an appeal to the Court of England???, and then wait for a decision and only then commence buying. They indicated almost another 2 months before they can start.

To this day, I've wondered why the Federal Circuit was so dismissive of the appeal of Judge Du's ruling. It crossed my mind that there was something unusual going on. Perhaps one of the judges knew Judge Du personally -- not a far fetched possibility in the small circle of federal judges nationwide -- and thought the Amarin lawyers were insulting and belittling to Judge Du in the way they wrote their appeal papers. As I recall, Amarin's lawyers toyed with the concept of "obviousness" in a way that a friend of Judge Du might have thought was condescending toward the judge and her reasoning. Judges tend to get somewhat defensive when they feel like a fellow judge is being mocked or unjustly cast in a bad light for doing her job, or at least trying to do her job.

Generally, a pithy one-page dismissal of an appeal of this kind of importance is rare. In the case of the Amarin arguments earlier this month, the panel will have to carefully word its opinion so that the lower court judge has clear instructions on how to proceed and why the case is being returned to him. And since it's such a sensitive subject of law (skinny labels) to small pharmaceuticals and the vulture generics who want to steal their products, the judges will likely be careful to make clear that they're not trying to set any precedents with their handling of the Amarin case, especially since the lawyer for generics made it sound like the judges would be rewriting law and eliminating skinny labels all together if they revive the case. One judge did a great job on the spot of shooting down the balloon that the lawyer for generics floated to that effect, but they'll want to make it doubly clear in their written opinion that the judges all agree with what was said off the cuff. So careful and thoughtful wording will go into this decision, regardless of its length, which probably adds weeks to a ruling coming out. Still, I hope I'm wrong and we see a ruling tomorrow because I think Amarin's share price will get a nice bump even though any of us who heard the arguments already know the outcome.

Capped at .8888 today.......... good price to buy back 56 Million shares perhaps?

and they aren't covered by your insurance provider.....cheap bastards....

https://www.tipranks.com/news/company-announcements/amarin-shareholders-show-strong-support-at-annual-meeting

I was tempted to swap out my statin for the better tasting Oreos, but they are a bunch more expensive.

Kiwi, I'm not sure there would ever be enough real world evidence to satisfy you. We just haven't greased the right palms yet for this to take off in the EU and China but we'll get there. The drug works. There's plenty of evidence that shows this. Statins lower cholerserol and so does eating Oreo cookies....... both have side effects yet Oreo cookie side effects take years to materialize..... yet Statins are prescribed like candy.......as soon as we can break through with a few more loud mouth, connected, influential thought leaders, sales and reimbursements will ramp up.

Ram. interesting pt of view .
Mine is summed up as follows
. Critics argue that companies sometimes use buybacks to artificially inflate stock prices or to benefit insiders with stock-based compensation.
Additionally, if buybacks are funded through debt or at the expense of necessary investments in research, development, or infrastructure, they may not always serve the long-term interests of the company or its shareholders.

So Co mgt should be happy re their options and RSU's that vest ...they should make out pretty well if the stock doubles from here on the buy back .
From poster Hayward
Looks like they all received 180,000 at .87 Options and 50.000 free shares no wonder they stepped on the PPS IMO up on monday

Meanwhile ...the EU patent life has been extended out to ...forgot exact date but at least another 5-8 yrs .
So IMHO the $50m would have been better spent developing the real world evidence to increase the level of evidence rating and garner more / wider EU reimbursement .
Kiwi

hayward, why didn't the price respond upward?

Looks like they all received 180,000 at .87 Options and 50.000 free shares no wonder they stepped on the PPS IMO up on monday

Could it be the bearish TA conditions which have caused a 22% decline since the rejected April high at the ice line? Bearish TA trumped the price action so much today that it failed to follow the sharp rally in the Biotech group, small cap stocks, and the general market rally.

Canam, Sorry. I only answered half of your question. The judges are not still deliberating. Cases are discussed after the arguments. What takes time is writing the order.
Sleven,

Canam, Non precedential rulings usually come about a month after oral arguments. If the ruling is precedential it's usually about three.
Sleven,

Yes all that is published on AMRN website, yet I haven't seen anything posted or published by MarketWatch or Briefing.com, etc..

This Ihub board has been told it can be anywhere from under 24 hours (rule 36 beat down) to a few months from the orals.
Total guessing game

Are the judges still deliberating? Is this normal to take so long for an answer from them?

Kiwi, it makes me happy..........they don't have to buy it back but if they do at under $1, I for one am delighted. I forget the actual price they sold around 20 mil shares at $18 to raise cash ($360 Mil) and now they MAY buy back 50 million shares at under $1/sh. Brilliant if you ask me.

“We thank our shareholders for their engagement and for taking the time to vote on key matters for the Company,” said Odysseas Kostas, M.D. and Chairman, Amarin’s Board of Directors. “Most notably, we are pleased to have received shareholder approval to execute the planned share repurchase program which puts us one step closer to returning value to all shareholders. We look forward to completing the necessary steps to begin share repurchases as soon as possible.”
Since theres no detailed plan to increase the level of evidence rating in the EU ...lets just buy back some stock and keep everyone happy
JMO
Kiwi

Thanks everyone for schooling me on E-EPA! It was an amazing ride! I got a lot of laughs!

From now on Vascepa will be Elektra-EPA for me! I nominate Jennifer Garner to advertise once she's available.

? Didn’t Publish it? All proposals were approved. Including stock incentives.

Ok they have announced the results of the board meeting but did not publish it on the market? JUST wondering why?

Hi Joe,
Ever think about going back and being a “consultant?” I’m sure whoever called you needs your expertise? All you have to do is walk around with a clipboard or a laptop and oversee the job?

As for restaurants in the Phoenix area. There’s no shortage. Me and the missus enjoy going to an “All you can eat” sushi restaurant. For $20 each you can’t beat it. Las Vegas and Volcano rolls are our favorites.

The street where I live is lined with mini food trailers that people have converted. So, there’s no shortage of food options. Mostly Mexican food. There’s one though I’m curious about, it’s a “Crepe” trailer. Unusual, I think I’m gonna have to try it…

Joe, I am eating more of those homemade BLT sandwiches since I moved to the NW. To tie in with Nuke's question, there are a number of highly acclaimed restaurants around the Portland area - kind of a foodie town where people will wait in line for hours in the rain to get a table. Unfortunately for me, after a few visits, I'm broke. Expensive as hell compared to what I was used to in Florida. Take care of yourself.

How’s it going? Any good restaurants in Colorado Springs?


Yup. There's a dollar and rapidly growing area. Nothing like the Bay Area. Haven't gone to any. I'm starting to put it together after the wife's passing after years of caretaking. I did a short piece on Vascepa for the local Parkinson's Support Group newsletter. Waiting for it to show. I was asked to come to work back in the Bay Area. I'm too gimpy to meet my standards. If I'd known I was gonna live this long, I'd a taken better care of myself.

Carry on. And I know you will.

Hey Joe, you’d enjoy this. I had to go back to work at the Power Plant. Lots and lots of activity that you would appreciate.

Replacing Low Pressure Feedwater Heaters and Turbine work. Right up your alley.

At 72, I’m feeling it, 12 hour shift work is hard on the old bones. I’m happy that I’m still able to keep up with these kids. And so them a few things.

Good one Joe, BLTs, now there’s a good sammich.

How’s it going? Any good restaurants in Colorado Springs?

Nuke

https://amarincorp.com/news-and-media/amarin-announces-results-annual-general-meeting-shareholders