Amarin Corp PLC (AMRN) News

Have to look through the details, but a Net Loss of $50M for the quarter on a nice uptick in revenue. Looks like Cost of Goods Sold killed us. Big rise on Cost, plus a big Inventory write-off.

"especially if the shares
are shorted down further"

Only if the shares go down further. There I fixed it for you.

I guess at this point, with not much left in this investment it doesn't really serve much to bail, so I will go down with this till the end I guess. Been here for more than a decade so I may as well see it through to the end.

On a more concrete note, any info about how market share here fared this last quarter? TIA

A reverse split also affords Denner/Sarissa the
opportunity to acquire a larger stake in AMRN
after the split takes affect, especially if the shares
are shorted down further. After that, Denner decides
whether or not to initiate the share buyback which
would further increase their ownership position.
Of course, this is all at the expense of retail. Can
retail still benefit? Depends on what the ultimate
game plan is. An eventual BO by BP would be good...
A BO by Denner would NOT!

Access to capital markets is another way of saying maintaining the listing... they remove de-listing fears by getting back above the arbitrary $1 level.

Then they shouldn't have said they are doing it to preserve access to the equity capital markets, giving the impression to the unknowing that they anticipate needing money.

Aaron Berg commented, "Building on our efforts and results in 2024, we continue to identify steps to advance the company." How about once in a while cluing us in to what some of those steps might be. Because we have seen or heard little.

Denner is smart... anyone who dumps because of a RS alone is less so. Unlike most RS situations, Amarin has no need to raise cash. De-listing worries will be removed. If the company deploys the buyback on any RS puke, it will significantly enhance shareholder value (more than deploying it higher to push above $1). I called for getting this over with earlier but will be adding on weakness. The Reverse Split is, in and of itself, meaningless!

Access to capital markets... For what reason... to lose more money.

I guess some knew and that could be why we sank back to the 40's from mid 60's.

Using the words "ratio change" instead of reverse split.

It’s on Yahoo finance and it is definitely a 1:20.
Of course I changed my stance real quick these fuking idiots just slaughtered us as retail.

Wow, you changed your stance real fast. A few posts ago calling sellers brain dead.

Not sure where you saw that information? If they do go ahead with a RS it is not that surprising for it to be a 1 for 10 or even the 1 for 20. Saw some here thinking it would be 1 for 4. Not a chance.

EDIT: I now see it under NEWS for Amarin. You are correct. 1 for 20. Guess the company really didn't have anything else up their sleeve.

Well if the reports are correct of the 1:20 split it’s over for us as retail. Been nice knowing everyone. I am in shock.

Kiwi,
https://www.thefdagroup.com/blog/505b2
Sleven,

Good luck to both AMRN longs and shorts for tomorrow earnings call. While I still believe it will be a non eventful salad of words from Amrn mgmt, there is a small hope they might say something to support/boost the share price in a possible way. Let’s see.

Oh bother :--)
Required Studies:
The studies may include:
Preclinical Studies: In vitro and in vivo animal studies to evaluate the pharmacokinetic, pharmacodynamic, and toxicological profile of the drug with its new route of absorption.
Clinical Trials: Phase I, II, and III clinical trials will be necessary to determine the safety and efficacy in humans. These trials will compare the lymphatic absorption route with current standard methods.

Kiwi

JR. the fastest / easiest way is to work with NVS on the trial they are currently running for Inclisiran in Germany
Other then that ...read my response to N7
Good luck tomorrow
I think this is may be the trial
VICTORION-(NCT05030428)
Full Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease

Description: This Phase III trial investigates whether inclisiran, a small interfering RNA (siRNA) therapy targeting PCSK9 to lower LDL-cholesterol (LDL-C), reduces major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke. Participants receive 300 mg inclisiran sodium (or placebo) subcutaneously on Day 1, Day 90, and every 6 months thereafter.

Status: Actively recruiting, with an estimated primary completion date of December 2027.

Relevance to Germany: This is a global trial with sites in multiple countries. Germany, a key player in European cardiovascular research, is highly likely to be involved, especially given its participation in prior inclisiran trials (e.g., ORION-11). Specific German sites aren’t always publicly detailed mid-trial, but Munich, Berlin, or Leipzig are plausible locations based on past patterns.

May not be the trial I was thinking off . They are running one exclusively in Germany ...20 mth on drug



Kiwi

Sure ...this is the easiest / fastest way ...but they may not qualify if as Capt says ..its bypass's the liver


The 505(b)(2) pathway is a type of New Drug Application (NDA) in the United States, defined under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. It’s a hybrid approval process overseen by the FDA that allows a drug sponsor to rely, at least in part, on existing data not developed by the applicant—such as data from a previously approved drug—while supplementing it with their own studies. This distinguishes it from a full 505(b)(1) NDA, which requires all original data, and from a 505(j) generic drug application, which relies entirely on bioequivalence to an existing drug.

The pathway is often used for drugs that are variations of already-approved products. Examples include new formulations (e.g., extended-release versions), new indications, new dosage forms, or combinations of previously approved drugs. It’s a cost- and time-efficient route because it avoids duplicating studies already conducted, like some preclinical or safety trials, but it still requires the applicant to provide evidence of safety and efficacy for the proposed changes.

A key feature is that the referenced drug (the "listed drug") must be an FDA-approved product, and the applicant can cite publicly available data, like published studies, or data from the listed drug’s NDA, though they may need a right of reference if the data isn’t public. The 505(b)(2) also triggers a review of potential patent or exclusivity issues tied to the listed drug, which can lead to delays if there’s a 30-month stay due to litigation or a period of market exclusivity (typically 3 to 7 years, depending on the change).
It’s a strategic option for companies looking to innovate without starting from scratch. Think of it like remixing a song—you use the original track but add your own spin, and you still need to prove it works.

Kiwi

On my Yahoo Finance for Amarin it shows an estimate of -.03 for tomorrow. I think earnings will not be that important. Cash drawdown, and what they say will be critical. Unless that loss of 3 cents shows up as a loss in the double digits. Good luck to all of us.

Agree that the new formulation has to be the carrot they dangle in front of BP. Will it be enough to entice them, who knows.

Kiwi, I do not know enough about drug trial requirements to know if this is the case. But even if it is, it does not mean that a BP is not willing to buy Amarin and assume the responsibility of running the trials themselves, post-acquisition. If there is a strong enough case for the new formulation, then a BP may be willing to pay good money for it.

The fact is, if Amarin was not planning to leverage the R&D they are doing on the new formulation, they wouldn't be wasting the money and resources on its development.

That is some interesting research. I really
hope AMRN is keeping this secret for competitive
reasons...However, I hope if that is the case they
would disclose whatever they can as to what their
game plan is and how well it is working.

Perkins Cole who represented Amarin and won the Appeal against Hikma, is apparently suing the Administration. Not sure if this affects their representation of Amarin. 

Well that didn't work too well:

https://www.google.com/search?q=does+the+fda+require+new+studies+for+drugs+using+lymphatic+system+for+absorption+rather+than+portal+vein&ie=UTF-8&oe=UTF-8&hl=en-us&client=safari

I am guessing the new formulation would be the additional kicker to coax a BP into a deal.  Don't know how many hoops or how long it would be that tge FDA would require but it is doubtful a current standalone Amarin could do it. Here is an AI take on this:

"AI Overview
+1
Yes, the FDA generally requires new studies if a drug's absorption route relies on the lymphatic system, rather than the conventional portal vein, because the lymphatic system offers a unique pathway that can bypass the liver's first-pass metabolism. Here's a more detailed explanation:Lymphatic System as an Alternative:The lymphatic system provides an alternative pathway for drug transport, enabling a bypass of the liver's first-pass metabolism. Significance of First-Pass Metabolism:Drugs absorbed into the portal vein (the conventional route) undergo first-pass metabolism in the liver, which can significantly reduce their bioavailability (the amount of drug that reaches systemic circulation). Lymphatic Absorption Benefits:Drug transport via the intestinal lymph circumvents this first-pass metabolism, potentially enhancing oral bioavailability, especially for drugs that are highly metabolized in the liver. FDA Requirements:While the FDA doesn't have specific requirements, researchers must conduct adequate studies to demonstrate the safety and efficacy of drugs absorbed via the lymphatic route, and they must also address any concerns related to the unique characteristics of lymphatic absorption. Examples:Some examples of drugs that have shown improved bioavailability when delivered via the lymphatic system include methotrexate, paclitaxel, and cyclosporine. Focus of Research:More research and innovative technologies are being explored to exploit the lymphatic system for targeted drug delivery. "

Kiwi, Please post the FDA guidance that supports your opinion.
Sleven,

CPT, Would be great to see some confirmation of this
from AMRN, along with the game plan for the development
of this new EPA formulation. I would also like to see what
Dr. Bhatt has to say about this new formulation. Your excellent
graphic on this would make it possible for the concept to be
explained to a BP in just a few minutes. (My fantasy would
be for Alex Denner & Dr. Bhatt use the graphic to explain this
to NVS.) As always, my POV is that the sooner a BP gets behind
this, either through a JV, BO, or partnership arrangement, the better
the legal, financial, and political protection that could accrue to this.

Thanks for that word/image discussion, Capt.--perhaps the statin could still be eliminated for statin-intolerant individuals. 

North, If you have the contacts, you should reach out.
Sleven,

I currently don't know if the CEOs of Dr. Reddy or Hikma were in the room to hear this, but CNBC-TV  today reported that the FTC Chairman just promised those CEOs that were in a meeting with him that the FTC will take their companies to Court if it finds any conduct events or merger activity that hurts/harms the American population. 

Sounds to me that the FTC is very ready to investigate the fraudulent, culpable, inequitable conduct/activity of those 2 miscreants in their post-trial court brief in a Nevada District Court a few years ago. What the FTC/DOJ/FBI now need are the facts and law related in our Amarin stockholder/EPA Drug Initiative II Petition for Writ of Certiorari, on which facts/law no court or federal agency has expressed a rationale opinion. The cardiovascular and monetary health of the United States has been compromised/harmed by their post-trial actions, deliberately imposed on the Courts.

Capt. you know that to get the R-IT indication for this new formulation that bypass's the liver ??...AMRN would need to run a large double blinded Outcome trial for at least several years . But whats another 5 plus years and mucho $ , between friends
Kiwi

That would be phenomenal .......

This is how we get the US IPE market back!

Here’s a quick illustration that distinguishes the differences in the uptake of EPA between VASCEPA®’s current formulation and the forthcoming LR-EtEPA formulation. The current formulation (Plain-EPA) is delivered through the Portal Vein Delivery System. In this system the first pass is through the liver which absorbs a significant amount of the EPA thus diluting the uptake at the target organs.

On the other hand, the Lymphatic Delivery System bypasses the liver and delivers directly to the target organs. The process is described in the LR-EtEPA patent application (WO2023146984). This new formulation can deliver from 170-296% more EPA to affected organs than the Portal Vein System. This could increase drug compliance, reduce the number of daily doses, cut Rx prices 50-75% and very importantly, incorporate easily with a Statin + VASCEPA® one a day combo pill!

Honestly I really like the setup here. $10 is my long term PT. I think Denner gets it done by the EOY. Most will exit along the way up but those that hang tough will be rewarded once again IMO.

https://www.courtlistener.com/docket/59859757/dr-reddys-laboratories-inc-v-amarin-pharma-inc/?page=2
Sleven,

Good luck to Jron the short tomorrow. My guess is its going to be same old same old its undervalued blah blah blah. Hopefully I am wrong if now Jron will probably make money on his short tomorrow.

Elect clowns you get a circus

"I am just waiting for the MDCO blueprint to play out"
Larrybirdlegend
Me too

If Jron is to be believed Denner has had master plan all along and is just waiting to unleash it.

I actually think they could do both of these when the new formulation is ready. I think it is how they take back the U.S. market.

💥💯 Um, yes please!

Selling to a BP for $10/sh would be new...... let's do that instead

Amarin needs to do something new.....An AG or a start to develop LR Et EPA comes to mind.

In less than 20 hours we will find out if it will be mums the word or whether there is some sort of as of yet undisclosed plan.  Setting my alarm since I am now in a left coast time zone. No matter what, unfortunately the market is in a state of turmoil. What's new. 

North, these 2 patents are tied to the Amarin and Mochida collaboration for FDC.

North, I've tried to copy and paste but the PDF files are protected from being copied. Below is an excerpt from one of the files. From EU patent files.

EP4338805 – EPA for use in reducing the risk of NON-FATAL MYOCARDIAL INFARCTION in a subject on statin therapy
Status: 15.01.2025 Grant of patent is intended

EP4342546 – EPA for use in treating the risk of NON-FATAL STROKE in a subject on statin therapy
Status: 15.01.2025 Grant of patent is intended

Give the man his due , He is an expert on predicting the past

Great INformation ! Stock now in the 40's this is yet again another wonderful buying opportunity BUY BUY BUY . The charts show a double kangaroo houdin inversion coming I tell you what it means after it happens

Management never says a work. Nobody has any idea what is going on so it does not matter if they have 300 million in cash.

Well Rosem...... I figured over and above helping to find waste, fraud, and abuse in the government, there would be benefits to TESLA when it comes to getting regulatory approval for Full Self Driving and Optimus robots..... we'll see. In the mean time, I sure hope we start getting upside surprises tomorrow and get this AMRN investment out of the toilet.

North is there a problem opening the link? on left side, it shows a link for "all documents"
Below is link the grant of one patent.
https://register.epo.org/application?documentId=M5VLYMREQQFGE5M&number=EP24152359&lng=en&npl=false

I agree, sleven. New patents, new generics with unknown compositions in capsules, and new patent infringement suits filed against new and old generics where appropriate. Nothing absurd about that--even generics are aware in Delaware and New Jersey in current litigation.

Save everyone some time, lizzy, and print text of application or patent claims shown in respective claims. I'll return later tonight to view those claims.