Amarin Corp PLC (AMRN) News

Do you have any concerns with AMRN remaining as a going concern, with regard to cash flow, exclusivity loss, etc...? None


I'm still trying to figure out if they will conserve cash given the PBM news or move forward with the buyback.
I think we can only wait until we get more color on this next week.

Duplicate post

“is this is the first time in memory that they didn't pre-release prior to actual earnings release.”

I may be wrong on this, but Q2 shouldn’t be too bad, and I am guessing that when they release those earnings they will warn about Q3 since that quarter will be impacted by the CVS Caremark drop.

While anything is possible, all we can go by is what they tell us so here's a snippet from the Q1 release.

However, as a result of our IPE market leadership and prudent expense management, the U.S. business delivered significant profit which funds our operations in Europe and supports our cash position.

I have to believe this team has a good handle on the cash management and I also believe they have been buying back some share..... but that's me.

One thing I do find interesting though is this is the first time in memory that they didn't pre-release prior to actual earnings release. Did anyone else notice this?

That is a good question concerning whether they go forward with the BB considering the PBM news. They formally announced the buyback on May 1, 2024 and some here have postulated that Amarin would have at least had an inkling that they could be losing CVS Caremark. But I notice that they filed with a conditional share repurchase with the SEC on Jan. 9, and on Jan. 22 in a letter to shareholders they mentioned their intention to proceed with a share buyback. So, I myself and not sure as to when they truly found out about the CVS Caremark decision and whether this will impact their BB plans. Holding pattern it seems right now.

Do you have any concerns with AMRN remaining as a going concern, with regard to cash flow, exclusivity loss, etc...? I'm still trying to figure out if they will conserve cash given the PBM news or move forward with the buyback.

Thanks MMS.

It's really hard to make any sort of evaluation of gameplan or timeframe on this one. I'll give you my *thoughts*, but that's all it is.

Denner is in a unique position where he has complete control of the board and the company. That is unusual, so it's not your typical "gameplan". Despite what some people have said over the past several months, I don't think Denner is going to "just dump it for 2 bucks". That is what people WANT so they can be done with this. But it has no basis in reality. If you look at the numbers, I can't think of any scenario where Vascepa is worth less than $5 a share. And even that is on the far low-end of reasonable ($5/share implies roughly $450-500M in PEAK revenues).

I think Denner needs a big win out of this one. His portfolio is sucking wind, and the majority of his holdings are in larger companies right now, so there's not a ton of upside there. But he has the opportunity to blow the doors off things with a big win with Amarin.

A reasonable starting point would be $10/share (IMO). That implies roughly $1B in PEAK worldwide revenues. I think that is very attainable for a BP. VERY attainable. But this does not really consider upside from anything beyond what we have in the U.S., plus China, EU and some little revenue in the RoW. If they find a way to re-capture the U.S. market, either through litigation or a new formulation, then all bets are off, and the number should go up from there.

But as it stands, I think $10-15 seems attainable. And I think the longer it takes, the stronger likelihood of a bigger number. If Denner thinks he can't get more than 5 bucks, he's not holding this thing for 3 more years. He's dumping it. But if he thinks he can get $10-15 (or more), then he can be patient and let those compound returns accumulate until the time is right.

I don't think anything will happen until there is more clarity on European approvals in Italy, France, and possibly Germany. They need to get those across the finish line. Amarin rolling out Vascepa on their own exposed the weakness across the globe, so now BP's that may have been champing at the bit in 2019 or far more reluctant to pursue Amarin until/unless they have assurances that they can actually get paid in the biggest countries they want to be in.

As far as litigation, I don't think they will wait for that. The litigation against Hikma could take 3 years, 5 years, 10 years. No way of knowing (unless there is something they already know). The GSK/Teva case has taken 10 years, and it's still not done. If we find a way to settle (favorably), in the next year or two, then that would be icing on the cake.

If I had to bet, I would say a sale happens late 2025 or into 2026. But that's also without knowing much of anything that is going on internally. I think the biggest clue that something is starting to happen will be when/if we see a flurry of activity (PR's, etc.) and rapid price growth. But while we still linger around a buck or less, nothing is happening.

Lol

Which stock are you referring to? I assume not AMRN. 250.00 to 300.00 stock

250.00 to 300.00 stock

Thx for all your infographics, really nice.

As an European the only thing i can say is; We are like Chinese, time is a tool.
Means in our nature were really slow.

Biobillionair - Jason Williams - please help his kids if you can.

https://www.gofundme.com/f/support-jason-r-williams-childrens-education

Just adding to the discussion here a while back about PBMs. Not only do they screw the pharmaceutical companies, this piece discusses how they screw some pharmacies. This story is specifically dealing with Walgreens but applies to others. Notably the author of the article does not seem to think the FTC will be successful in reining in PBMs:

Walgreens still operates the largest chain of retail pharmacies, with about 8,700 in the U.S. and thousands more abroad. Its enormous size is an advantage for the pharmacy chain when it comes to sourcing prescription drugs and consumer goods. Unfortunately, pharmacy benefit managers (PBMs) that dictate how much reimbursement pharmacies receive when they fill prescriptions are eroding this advantage.

The three largest PBMs are also owned by insurers: CVS Health, UnitedHealth Group, and Cigna. None of these businesses are obligated to ensure Walgreens can turn a profit when it fills prescriptions. Moreover, all three also manage their own mail-order pharmacies, so there's a strong financial incentive to turn patients away from Walgreens and other retail outlets.

When the company reported fiscal third-quarter results in June, it had to lower earnings guidance for the year to reflect what it called "pharmacy industry trends" caused by PBMs. The stock's recent price is less than four times management's adjusted earnings estimate for the fiscal year that ends in August.

On the one hand, Walgreens stock could produce huge gains if earnings stop falling. Then again, the stranglehold the consolidated PBM industry has on retail pharmacies isn't likely to subside anytime soon.

The Federal Trade Commission (FTC) is preparing to sue CVS Health, UnitedHealth Group, and Cigna over their drug pricing practices, but success doesn't seem likely. It's probably best to avoid investing in independent pharmacy chains like Walgreens unless the FTC's suit against the three big PBMs succeeds.

https://www.fool.com/investing/2024/07/23/2-beaten-down-dividend-stocks-with-ultra-high-yiel/

I’ve been told Livalo has a different MOA than the others. It sure works for me.

$AMRN Here’s a fun Bonus Graphic showing the first 10-month Launch of VASCEPA® (USA) vs. VAZKEPA® (UK). VASCEPA® Launched in the USA in January 2013 and VAZKEPA® launched in October 2022.
For comparison purposes, consider:

1. Potential Patient Populations. I believe the estimated PPP for the MARINE Indication was 4.5 million and NHS estimated VAZKEPA® PPP at 425,000.

2. I used the limited 10-month reference because I’m missing November & December of 2013 and all of 2014.

3. The first 12 months of data are typically erratic (as seen here)

Summary: It’s always a slow grind no matter the drug or the country.
Patience my Friends!

Seve333, Not to mention that an end of the year share
buyback would take advantage of end of the year tax selling.

JRoon, I appreciate your level headed posts here. How do you see Denner's end game playing out, and over what time frame? Seeing both good and bad news and a really tight trading range for the stock on low volume over the past few months.

Trip88, thanks for the link. This is something that needs to happen. PBM's have way to much power and should be reigned in and/or done away with. Another example of taking advantage of the system and scamming the pharmaceutical industry for their gain.

Agreed that it might add to our knowledge of V’s activity wrt to other markers and parameters

But maybe it will add some firepower to Vascepa's efficacy? Can't think of a reason why they would report on it, otherwise.

Strange that they are doing it at the ALZ conference. I would think even CTAD would have been a better venue for that (CTAD is more scientific focused than ALZ Conference).

Yes, I mentioned that a couple of weeks ago that what is going to be reported on that poster is not any of the endpoints studied in the trial. I am guessing that what they are reporting is positive and of some value, but I agree with you that this will not move the stock.

I am guessing they almost have to delay it given the 25% drop in revenue they will need it to regain compliance in November. Earnings usually tank the stock. Depressing but it is what it is I guess.

Was looking at the BRAVE poster for the upcoming Alzheimer's Association meeting in a week. Since it seems that they are reporting findings on blood lipid levels, blood pressure, and adverse events (but not on the primary ALZ endpoints of the study), and they are NOT reporting at CTAD this year (they presented the trial design and primary outcomes last year), it's probably safe to assume that EPA for ALZ is not going anywhere (for now).

But it does make me wonder if they must have some other positive findings related to lipids and blood pressure? Otherwise, why would they bother with a poster presentation?

I don't think they are trying to ferret out every individual "violation". I think insulin is just the low-hanging fruit because it's use is so widespread, and ripe for abuse.

Hopefully FTC digs deeper than Insulin !

FTC preparing to sue top 3 PBM's
https://www.healthcaredive.com/news/ftc-to-sue-pharmacy-benefit-managers-caremark-express-scripts-optumrx-wsj/721021/#:~:text=The%20Federal%20Trade%20Commission%20is,Street%20Journal%20reported%20on%20Wednesday.

Well, you seem to have all the answers, so I'm not sure why you are here asking. We're just telling you it ain't gonna happen.

Keep in mind, the largest PBM in the country just dropped Vascepa, soooo...

But if you're getting paid to do this, then keep at it.

If the pharmacy has an incentive to do this $$, I think its reasonable. And if they get the incentive only when they do it, sounds like nothing is lost if they dont (business as usual). I am sure AMRN would be happy with a subset.

I guarantee you cannot get every pharmacist to call and verify the indication of every script. That's insanity.

Not even sure how you would go about requesting that.

That is a company problem. Skinny label is not amrn specific.

Good luck with that. Also you have the problem that many insurers are not covering V.

The pharmacist could call and find out the indication, for that AMRN would be compensating them for every generic verification.

Lunar, the problem is that doctors are not required to list the indication on their script. So a pharmacy wouldn't know whether it was for high trigs or CVD.

Without a requirement for docs to list an indication, its is virtually impossible to police all infringement.

Hello my Friends,

Here is a summary of the prescription data for VAZKEPA® in the UK (May 2024):
• VAZKEPA® growth was 6.5% vs. April (223,945 vs. 210,256).
• VAZKEPA® again improved its market share vs. Omacor (See Slides #6 & #7)
• Total LLT Market in the UK continues to grow and VAZKEPA® is slowly growing its market share in all 3 categories (Total Market, Omega-3’s, Non-Statin)

Here is the full report for May 2024:

https://drive.google.com/file/d/1cFb9_qAjU9vsQOebkFGRkhs6pOBjSmvZ/view?usp=sharing
Enjoy.

Hi Guys, I am a CS Engineer and currently working with a pharmacist on side projects related to pharmacy. I was wondering if anybody has any ideas what or if we could build something that would solve the skinny label issue. Perhaps AMRN could pay pharmacies through a platform, and in return pharmacies are validating reason for prescribing and what their system prescribed e.g generic or brand. With this data amrn can perhaps try and hold someone accountable.

Eagerly waiting Captains UK numbers but not knowing the full U.K. holiday schedule and all things being equal, looks like there are three fewer working days in June vs May. Add the typical summer slowdown, appropriate calibration may be in order.

According to an article I read:
The most common side effects of LIVALO in clinical studies were:
Back pain Constipation Diarrhea Muscle pain Pain in the legs or arms
I am presently using Lipitor (atorvastatin) and have some mucle pain & pain in arms and legs, but i see that Livalo has the same side effects listed ( as mentioned above.
So I am wondering if I should ask my doctor to swich to Livalo ??? perhaps it just works for some people but the muscle pain, etc persists when taking Livalo?

The article doesn’t state his LDL or trigs, but with a CAC score of 530 and BP of 160/90, he’s a walking dead man. More than anything, the article illustrates how heart disease patients are poorly served by medical professionals. They have one arrow in their quiver, lower LDL. Maybe triglycerides.

My point wasn’t about statin intolerance, it was that Vascepa wasn’t even mentioned.

I had muscle pain when I first started on statins. My doctor tried Lipitor then Crestor. Both were difficult. Then we tried Livalo (pitavastatin) Bingo! No problem!

In his defense, I don't think any cardiologist thinks IPE is appropriate for aggressively treating existing atherosclerosis (as a mono-therapy). Someone in this situation needs more aggressive treatment. IPE would obviously be beneficial, but would not be enough.

Then there’s Dr Keith.

Patient seeks an option to statins
Keith Roach, M.D.  Updated: July 22, 2024

Q: I had a CT calcium scan, and my score was 530. My doctor said that this was high, so he put me on a statin (Lipitor). But it debilitated me with so much muscle pain that I had to stop. I am wondering if there is something other than a statin to help lower cholesterol. My doctor told me to go on the Mediterranean-style diet, then check my numbers again. Last time, my blood pressure was 160/90 mm Hg. I also have a family history of heart disease.
A: I entered your information into a calculator (the MESA score, available at tinyurl.com/MESAscore) and found that you have an approximately 13% risk of having a heart attack, needing a bypass, or dying from heart disease in the next 10 years. This is high enough that treatment to reduce risk is clearly recommended. A statin like Lipitor is usually the first-line treatment, since we have decades of research showing that it reduces heart attack in people at a high risk. Treatment with a statin is expected to reduce your risk to about 10.5%. A Mediterranean-style diet is expected to reduce your risk by another 1% or 2%.
When a person can’t tolerate Lipitor, I usually stop the drug for at least a month, then restart them on a different statin, preferably one with a lower risk of muscle pain. If a person really can’t tolerate any statin, then another option is the new treatment bempedoic acid, which works similarly to a statin but does not affect muscles. Unfortunately, it’s very expensive. Some other options are a PCSK-9 inhibitor, which is also very expensive, or ezetimibe, which isn’t quite as effective, but is better than no treatment at all.
Getting your blood pressure down (ideally below 130 mm Hg) either through lifestyle changes or medication can also reduce your heart disease risk.

I don’t disagree that it would be easy to hide that volume, but it would seem to me (I could obviously be wrong) that throwing in an additional buy side volume of say 300K shares would tip scales enough to see the stock price advance which might then even cause a snowball effect of other market participants piling in (or shorts covering).

VAZKEPA scripts for the UK are in. I'll have a full report in a few hours after my dentist apt.

RMB, I'm still not ruling out the possibility that Cantor has been buying. Their buying limit has generally been 375,000 shares or less since mid-May, which is a pretty easy amount of shares to hide among even a low-volume day.

Could, that is a possibility. I was hoping that since the market is "all-knowing and forward-looking" that the 25% drop in revenue has been digested by the market to some degree. Those hopes might be misplaced though, as the information about the loss of the portion of sales was mostly a footnote in a pr about something else.

And although the buyback is supposed to be within certain limits in terms of daily volume, I am still of the opinion that even such a muted buyback would raise the stock price - something we really haven't seen. So I take that with the information that JRoon has posted and using Occam's razor, deduce that the BB has not begun yet.

Here’s another defector that might be coming back: @Drpablocorral What Webinar on TRL & Hypertriglyceridemia could possibly exclude icosapent ethyl (IPE) as a contributor to Residual Risk of CVD?
#IPE #EPA pic.twitter.com/O9TPcYkBQa— Mike Everts (@GeoWizz_) July 23, 2024

#IPE #EPA Do I finally see some cracks in the anti-EPA armor from @DrLipid ?
“Once the apoB is controlled high dose EPA can further lower residual risk”https://t.co/5XeEuS72Bl pic.twitter.com/Ll6EKUot2Q— Mike Everts (@GeoWizz_) July 23, 2024

If management expects the share price to suffer as the 25%
loss of US revenues hits future quarterly earnings reports,
perhaps they will decide to delay the share buybacks for
a later time if they expect the share price to be lower then.
Frustrating to see the share price stay so low. I only hope
we see Sarissa pick up more shares before it becomes
apparent that the share buyback has kicked in.

Share count update...Amarin filed an updated Statement of Capital to UK Companies House. Though I cannot see the actual count yet (they have not uploaded the filing document yet), it shows the amount of capital the shares are worth, and it actually went up. So, as of July 17th no shares have been purchased by Amarin.

As previously discussed, there is still the possibility that Cantor has been buying, and not yet delivering to Amarin. But we won't know that until they (if they) tell us.