Amarin Corp Plc (AMRN)

[Nukemtiltheyglow]

Geez, give it a rest willya? Denner and company is still cleaning up the mess from the previous “inept” management scum bags.

[CaptBeer]

Thanks I’ve been waiting for the actual peer reviewed journals from the ACC24 Presentations.

[DMC8]

Effects of icosapent ethyl according to baseline #residual risk in patients with #ASCVD: new evidence from the REDUCE-IT trial now out with #openaccess in #EHJPharmacotherapy 👉 https://t.co/4LYIT0fb5x @EditorEHJCVP @FeliceGragnano @MattiaGalli10@DLBHATTMD @gabrielsteg pic.twitter.com/bsKSFQCMt6

— European Society of Cardiology Journals (@ESC_Journals) May 4, 2024

[Number sleven]

Kiwi, By the way. This new management team is who you endorsed.
Sleven,

[Number sleven]

Kiwi, If you want the company to make different decisions, talk to them. I can only track decisions that they make. How long did it take for statin drugs to gain traction? You apparently don't believe that the drug has clinical value. I do. Generic competition is forcing the price cuts. This is killing our margins and profit in the US. Is this a surprise for you? I believe both past and current management understand how to deal with this problem. Supply chain will be the key
Once again I urge you to sell your position and move to a company that you can understand.
Sleven,

[Whalatane]

Well your mindsets seem to be to stick with the same ol same ol ...cos eventually ....eventually , the entire Cardiology community will see the light and start aggressively writing scripts ..especially in the EU

Meanwhile ...do the math here, Q1 24 over Q1 23 saw a 41% decrease in US revenues . Similar will happen in Q2 and Q3 and Q4 because the major health providers like Kaiser have switched to generic V or are forcing AMRN to beat generic pricing to retain their market share .

Great deal ..hey we have retained our US market share ...but were losing $ doing it ..but never mind

And while this is going on in the US ...script growth ( except in Spain ) is barely moving .

But lets stick with the same ol same ol ...with a $50m share buy back thrown in so mgt options that vest next April, can maybe cash in .
Cos thats the best idea we ( mgt ) can come up with .

Kiwi

[Number sleven]

Chromosome, I think you and I have a similar mindset. I look forward to more conversations. Enjoy your weekend as well.
Sleven,

[Chromosome]

Thanks NS…I was referring to the post remand decision by the district court…assuming it goes back which from the tone of the call seemed to indicate it will..
Anyways thanks. I always enjoy your posts as I feel it it one of the more informed ones. I also enjoy contrarians that are well research like Tatsumaki who although I don’t agree with at least has well articulated reasoning.
I work in oncology now and it’s amazing how easy it is to get accelerated approval based on surrogate end points like ORR and people are asking for more trials to prove what is already proven through the Reduce-IT gold standard.
Enjoy the weekend everyone…and the beer

[Number sleven]

Chromosome, I agree with your opinion about the European market. It's a time issue. As far as the infringement suite goes, the court of appeals can't actually make any rulings that directly effect either party. They are simply making a determination about the dismissal by the lower court. If they send it back, the suit picks up where it left off.
Sleven,

[Chromosome]

Thanks NS. I listened a couple of times. I am not a legal expert but am wondering if there is a scenario where it’s gets remanded and Hikma is forced to specify the indication in their marketing material but not face any retroactive monetary damages. My other thought is even if it gets added to their website and other marketing material, whether Dr.’s will actually pay attention to the new wording. Without any reps visiting Dr.’s, it’s hard to educate the physicians.
Bigger picture, for me personally everything positive that may happen in the US is a welcome and somewhat unforeseen upside. oUSA and especially EU market is big enough to warrant an attractive valuation…eventually. You need the patience of Job , which I have and I suspect most of the well informed posters here do as well.
Again, all jjust my opinion.
Have a great weekend.

[Number sleven]

RMB, I agree.
Sleven,

[Number sleven]

Chromosome, If you hadn't I was going to give you a link to the audio. It sounded like the court was going to remand this.
Sleven,

[Chromosome]

Yes NS, I did…..and?

[rosemountbomber]

Sleven I think things went pretty well for Amarin at the Appeals court. I am guessing remand but I am mostly interested in the wording and instructions of their order.

[Number sleven]

Chromosome, Have you listened to the oral arguments at the circuit?
Sleven,

[Chromosome]

Damn spell check..meant Nissen

[Number sleven]

https://clinicaltrials.gov/study/NCT04216251?term=Vascepa&rank=6&tab=results
Sleven,

[Chromosome]

Well Kiwi, I believe for people like Nissan and his buddies, no amount of evidence is good enough because their egos have been hurt and they will find another excuse to poo poo the results. Ignoring the US, just the big 5 in Europe should suffice for a reasonable valuation. Typically on the US market share in class peaks at 12-18 months (we have looked at a bunch of analogs). In Europe, the time to peak is much longer as it takes longer for the markets to build. With our new runway to 2039, that’s plenty of time. Plus and AG and China plus a little here and there, there is plenty of cause for optimism. Plus throw in a bit of legal upside (albeit low probability in the US). Of course that’s just my opinion and everyone should invest at their own risk.

[Whalatane]

https://eas-congress.com/2024/. Big Cardiology conference in the EU coming up

What's AMRN presenting ...anyone ?

Alright

Beyond LDL-c: Residual risk and Elevated triglycerides - Industry session sponsored by Amarin
Welcome and introduction

Presenter
Michel Farnier (France)
Lecture Time
14:45 - 14:50
Residual risk and Elevated triglycerides: Where do we stand in 2024?

Presenter
Lale S. Tokgözoglu (Turkey)
Lecture Time
14:50 - 15:00
Icosapent Ethyl in clinical practice : Who needs it the most?

Presenter
Azfar Zaman (United Kingdom)
Lecture Time
15:00 - 15:10
Icosapent Ethyl in clinical practice: What mediates the protective effects?

Presenter
Lluis Masana (Spain)
Lecture Time
15:10 - 15:20

Kiwi

[Whalatane]

Chromosome ..Well I am definitely in the minority .
You may think R-IT is the gold standard but because of the placebo used some major figures in the Cardiology world don't buy it .
Capt has a long list of non believers .
This affects script uptake here and in the EU

The current trajectory for AMRN ....significant decline in US sales , combined with minimal sales in the EU indicates a slow steady decline to oblivion ...not a BP buyout.

So what to do about that ?
Apparently nothing according to most on this board

Kiwi

[Whalatane]

Jim I was on Mevacor . Back then it was only for the HeFH indication I believe. Approval for primary prevention etc for CAD came years later ...1995 I think .
Above is just from memory .
The big change was Lipitor . I was given free samples that lasted about 6 mths ...handed out like candy on Halloween, when that hit the market .
Did you sell Lipitor ( Atorvasatatin ) also .?
Kiwi

[Mr Stockboy]

Not everyone is a statin user, or tolerant to statins.

IMO I'd love to see a study without statins, but not paid for by Amarin but by its acquirer. That would LAUNCH Vascepa/Vazkepa to the stars!!! Seriously.... (BTW, statins limiting cholesterol may have a brain affect called Alzheimer's -- not a joke).

[Jim Nasium]

Not really a bribe. It is fairly obvious from Kiwi's wife's and your experience, these trips, lunches etc., are SADLY what it takes to get some of these MORONS/physicians, to learn about something new. You really think these docs are going to sit in some conference room with coffee and toast to learn about some NEW CVD drug??There's a new one out every day!! What's really despicable, SOME interventional cardiologists are only making money when they're in the Cath Lab and purposely won't use anything not in the ATP guidelines!! I remembering selling Mevacor, the first "statin" drug in a huge metropolis, Cardiologists were some of the last docs to start Rxing. Every other industry in US is allowed to take these "reward" trips from their vendors, but not Physicians, or those in powerful positions in the hospital, i.e., CEO, administrators, etc. Medicine is corrupt and in serious decline, like everything else.

[alwayswatching1]

Because he’s the eternal pessimist. Still not totally convinced he isn’t Nissen lurking around here to torture us longs

[Chromosome]

Kiwi, I am not sure why you keep saying that AMRN should sponsor a small trial focused on sub-groups. Reduce-IT was the gold standard. There is still positive data coming out for and RWE is also emerging. If any investigator wants to further investigate, they are free to do so and I am sure AMRN can give them free drug but a full sponsorship, given the preponderance of data does not make financial or any other sense. I agree with NS; the rest of EU will eventually come on board. If anything, a better HEOR dossier leveraging RWE may be more effective.

[Whalatane]

Another example of a short CAD trial ...this time in Sweden

The SWITCH-SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial.
The trial aims to systematically evaluate the transition from using ticagrelor to using prasugrel as the preferred P2Y12 inhibitor drug for treating patients with acute coronary syndrome (ACS) in Sweden.
The administrative regions in Sweden will constitute the clusters, and the order in which they switch from ticagrelor to prasugrel will be randomly assigned.
The primary endpoint is the composite 1-year rate of death, stroke, or myocardial infarction.
The trial will establish an important standard for introducing and evaluating the effects of healthcare changes within the Swedish healthcare system.
The trial is designed to provide a systematic, randomized comparison between the use of ticagrelor versus prasugrel for treating patients with ACS in a real-world setting.

[Whalatane]

Try this with available Kaiser data

PRECLUDE-2 was a Swedish registry study involving over 100,000 post-MI patients. It found that the majority of these patients who have at least two cardiovascular disease risk factors showed a marked but gradual increase in incidence of cardiovascular death, MI or stroke during the follow-up period of three years. If all five cardiovascular risk factors studied were present, there was up to a nine-fold increase in incidence of CV events, compared to when only one risk factor was present.

Compare SOC vs SOC and Vascepa ...3yr study ....we have EU patent protection til 2039

Kiwi

[Whalatane]

RMB. As I have posted before . You pick a R-IT subgroup with a high risk reduction where the event lines separated fairly early . The Revasc rates ...especially second revasc rates as an example.
Real life example .
Wife was unable to dialyze one of her patients recently because he was complaining of chest pains . Sent to the ER where they found one of his coronary stents had re occluded ( plaque had reformed possibly as a result of injury to the vessel sustained at time of PCI ) .
Patient was not on Vascepa
So run a short trial ...or at least look at Real World evidence for these patients ....Kaiser must have lots of it by now.
SOC ( standard of care ) vs SOC plus Vascepa ...follow rates of re occlusion following a recent PCI .
Huge cost savings if re occlusion rates fall for those on Vascepa .
No placebo , open to all TG levels
Kiwi

[rosemountbomber]

Good insight. Only other thing it could be would be that they know the company is grossly undervalued and they can get a better return on their money than any other investment or expense.

[rosemountbomber]

I don't think (could be wrong) that the study you posted was done by a BP. And additionally, 68 weeks as they only had to show a reduction in LDL. With Vazkepa you wouldn't have one biomarker that you could show but would need to have a much longer duration trial to show MACE benefits. Now, if it just involves collecting, collating, analyzing existing data from patients in the RW taking V for the last 5 years, fine.

[Tatsumaki]

Well, when Denner suddenly starts buying and crosses 10% ownership, you'll know he already has an offer in his back pocket and has to wait 6 months before telling anyone else.

[Tatsumaki]

All the trips, the dinners, the fancy swag bags filled with expensive goodies is still alive and well. It's just shifted up to people with the authority to change Rx habits in an organization. You said it yourself, your wife doesnt have the autonomy to Rx a new drug on the market. Why spend those efforts on someone in that situation? Reps will focus on the dept. heads, executives or PIP developers. The consolidation of smaller clinics in to larger managed care operations just made it easier to manage for the pharmaceuticals from a top down approach vs. chasing after thousands of individual Drs. Win win for everyone as the clinic can spin the "we dont allow big pharma reps to bribe our Dr's" and BP can work over fewer people for the same impact.

[Number sleven]

Kiwi, What you think the company should do is irrelevant. We are investors not board members. We don't get a vote. You and I have access to the same information. We disagree about the outcome. If you are convinced that the Vascepa market won't grow, sell your position.
Sleven,

[Whalatane]

Snd. RWE studies are done all the time to inform regulators and physicians ...I've easily identified several .
Heres one on PCSK9's in Germany

A real-world, single-center study that examined the use of PCSK9 inhibitors (alirocumab and evolocumab) in a large patient cohort (n=635) in Germany. This study was conducted at the lipid clinic of Charité Universitätsmedizin Berlin and assessed the prescribing patterns and treatment outcomes of these novel lipid-lowering therapies in a clinical practice setting.

Kiwi

[Whalatane]

Here are some examples of real-world evidence studies on existing cardiovascular drugs:

Cardiovascular drugs are an area where real-world evidence (RWE) has been increasingly used to supplement clinical trial data. RWE can provide valuable insights into the real-world safety and effectiveness of these drugs beyond the controlled settings of clinical trials.

One example is a study that used insurance claims data to evaluate the cardiovascular safety of the diabetes drug Tradjenta compared to an older treatment, glimepiride. The study was able to replicate the results of the large CAROLINA randomized controlled trial in a much shorter timeframe of 6 weeks, compared to the 8 years it took to complete the CAROLINA trial. This demonstrates the potential for RWE to efficiently evaluate the safety of cardiovascular drugs.

Another example is a study that used electronic health record data to evaluate the real-world use and outcomes of the heart failure drug Jardiance. The study found that Jardiance was associated with reduced risk of hospitalization and death in a broad population of heart failure patients, including those not enrolled in the original clinical trials. This type of RWE can help expand the understanding of a drug's benefits beyond the narrowly defined patient populations in clinical trials.

RWE has also been used to evaluate the safety of cardiovascular drugs in patient populations excluded from clinical trials. For example, a European health technology assessment agency requested real-world data on the safety of a new oncology therapy in patients with limited cardiac function, who were excluded from the registration trials. The RWE analysis helped inform the coverage decision without the need for an additional clinical trial.

These examples illustrate how RWE can complement clinical trial data to provide a more comprehensive understanding of the real-world use and impact of cardiovascular drugs, ultimately supporting regulatory and clinical decision-making.

my emphasis
Kiwi

[Mr Stockboy]

The fact Amarin plans to spend up to $50M on the BB tells you they plan to sell the company. They're not spending it on advertising, building out another sales staff, not a new product, research, nope, nope, nope. Spending $50M on BB because they can as they move into the 6-12 mth window as the year goes on to sell the company. It is smart because it not only tightens the float, squeezes shorts, raises current shareholder holdings, it's obvious Amarin is saying it has enough cash on hand to get to the finish line--selling the company. So what's the time-frame for the BO? First-half next year when France and Italy are both known (good or bad). HFs will want in on the ride so there's going to be a lot of smart investors showing up.

[Whalatane]

N7. Dr Nissen has made this a scientific / medical debate . Real World Evidence follow up studies are done all the time ...including studies done by the German Health Dept . I linked a follow up real world data study they did on 2 blood thinners recently ...a short 1 yr study .

Regarding math resolving in our favor .
Here's a math challenge for U
Q1 2024 shows a 41% DECREASE in US sales vs Q1 2023 . Meanwhile sales growth in the UK / EU is minimal .
This company is shrinking right in front of us with the current game plan

Kiwi

[Birdbrain Ideas]

They don't believe it? Maybe Amarin can hire Judge Du to tour the globe, telling everybody how "obvious" it was that Vascepa could reduce heart attacks and strokes. She even got skeptical judges on the Federal Circuit and Supreme Court to believe her. What are a few European nations?

If they really don't believe Amarin, it shows how far the reputation of the FDA has fallen in the eyes of the rest of the world. The U.S. response to the first year of the pandemic will not easily be forgotten by the rest of the world.

[Whalatane]

Well no thats not how it all works now . Sales reps are prohibited from visiting my wife's Renal Dept ...and yes she does miss those free lunches with young male CQ model type sales rep pitching her some drug .
And I miss the all expenses paid trip to some resort ( I got to tag along ...room was paid for ) ...but sigh ..those are the sacrifices we must make .
Kiwi

[Tatsumaki]

Not jaded. It's just how real life works. Amarin needs to hold more all expenses paid 4-5 day conferences in the Canary Islands for Dr's in UK/EU instead of waiting on "the science". Invite the regulators from Italy, Germany and France while they're at it.

[JRoon71]

Kiwi, do you think it is also possible that, outside of the larger markets (UK, Spain, Italy, France, Germany, China, etc.), Amarin is deliberately choosing not to market to docs in those countries due to the cost/benefit? And maybe those countries are just carrots for a BP?

My thinking is that in the short-to-intermediate term, the cost to launch in a small market outweighs the benefit, and would just be a cash drain. So focus resources on the large markets, and let a future BP handle launching in the small markets with their existing salesforce.

Not sure of there is any validity to this, but was thinking about it recently. I just can't think of another reason why some of these small EU countries that have given the green light over a year ago (approval AND reimbursement) still have zero sales.

It's a bit different in the non-EU countries, where we have left it up to partners to launch.

[Whalatane]

Don't underestimate the shade Dr Nissen has spread ...it reaches far and wide .
Kiwi

[Whalatane]

Ha Ha ...oh jaded one
Kiwi

[rosemountbomber]

Inadequate presentations maybe? Or a lack of confidence by KOLs? Lack of confidence caused by inadequate presentations?

[Tatsumaki]

Boss goes to a Kidney disease conference ..does a deep dive with the Valtessa team ...comes back and says OK start using Valtessa. It was like a light being switched on.

Which resort town was the conference in?

[Whalatane]

RMB. Conferences / symposiums are big for launching new drugs in the EU / UK
Usually attended by heads of depts or the top team and then if convinced , issue a directive once back at the hospital .

In the US this happens also ...related to my response to poster Chromosome ... Valtessa was approved but not being used for lowering serum K at my wife's Renal Dept.
I asked her why not . Her answer ...Boss hasn't approved yet .
Boss goes to a Kidney disease conference ..does a deep dive with the Valtessa team ...comes back and says OK start using Valtessa .
It was like a light being switched on.

The conferences / symposiums aren't driving Vazkepa uptake in the UK , Netherlands , Sweden and AMRN mgt needs to explain why that is
JMO
Kiwi

[Number sleven]

Captain,
https://classic.clinicaltrials.gov/ct2/history/NCT04216251?B=12&A=11&C=merged#StudyPageTop
Sleven,

[Whalatane]

Re

You have an impressive memory Kiwi…

...thats due to all the Vascepa I've taken over the years ..:--)
Thx for the market analysis ...I owned both ZSPH and RLYP . My wife had dialysis patients continually ending up in the ER due to serum K overloads ( often from parties where they drank too much and ate the wrong food ) She prescribes Valtessa now.

In the CKD field theres interesting developments with treating serum phosphorus ...ARDX and UNCY

Good luck with AMRN

Kiwi

[CaptBeer]

According to the Clinical Trials website the PREPARE Study was updated today. Don't know what was updated:
https://clinicaltrials.gov/study/NCT04216251?tab=results

[Tatsumaki]

I remember way back when, just after Marine approval when Joe Z was touting more suitors than employees. But I think the idea of GIA (or an unreasonable expectation of a selling price) enamored JT to the point that he lost the focus of the primary directive.

The value to BP was Anchor. 10x Lovaza market. Well established, easily tested surrogate biomarker (trigs). A sales hook to convince to Dr's to switch from L to V right as L went generic... "Same great Trig reduction, no LDL-C increase!" Full regulatory exclusivity intact. This company's only purpose was to get Lovaza 2.0 developed, approved and sold off to a BP. He probably did have multiple offers in hand contingent on Anchor approval.

JT wasnt "enamored" by the thought of GIA. GIA is what you're forced to do when nobody wants to buy you so that's what he did. During most of JT's tenure, Amarin had nothing... a busted label and a half finished study everyone knew was just a rehash of Jelis. By time Reduce It came around, regulatory exclusivity was all but gone and there were already multiple ANDA's filed against the Marine label pending lawsuits putting the entire IP stack at risk. BP doesn't spend billions on a drug with 0 exclusivity.