Amarin Corp PLC (AMRN) Quote

RMB. Germany follows a different method on determining reimbursement then most of the other EU countries . Each EU is different but Germany stands out .

Taken another way ...any drug that gets reimbursed in Germany is almost certain to be reimbursed in the rest of the EU


Unlike countries like the UK, Germany does not use cost-effectiveness analysis or quality-adjusted life years in reimbursement decisions.
Decisions are based solely on comparative therapeutic benefit.
New drugs get immediate access to the market and full reimbursement for the first year, unlike countries that require health technology assessment before launch.
The reimbursement process is more centralized at the national level compared to decentralized models in some other EU nations.
Reference pricing based on therapeutic equivalence groups is more widely applied compared to many other EU countries.

Things change after the first year

r
The key steps for drug reimbursement in Germany after the first year on the market are:
The pharmaceutical company submits a dossier to the Federal Joint Committee (G-BA) demonstrating the added therapeutic benefit of the new drug compared to existing treatments.
The G-BA commissions the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the dossier and determine if the new drug provides an added benefit over comparator therapies.
Based on IQWiG's assessment, the G-BA determines if the new drug has a major, considerable, minor or no added benefit.
For drugs with added benefit, the National Association of Statutory Health Insurance Funds (GKV-SV) negotiates a reimbursement price with the pharmaceutical company. This price must reflect prices in 15 other European countries.
The negotiated reimbursement price applies from the 7th month after the drug's launch in Germany, replacing the initial free pricing period.
If no agreement is reached, an arbitration board determines the reimbursement price from the 7th month onwards.
For drugs with no added benefit, the reimbursement is capped at the price of the appropriate comparator therapy.


The problem I think is that Germany does not see any benefit above Ezetimbe ...used as the comparator ...so thats the most they would reimburse for Vazkepa . No way AMRN makes $ on Ezetimbe pricing
Kiwi

Thanks Kiwi. But are those drugs being reimbursed everywhere else in the EU?

RMB As of 2019, around 28 drugs had been withdrawn by manufacturers from Germany after failing to demonstrate incremental clinical benefit over comparators during the assessment.

I think most are initially approved but some are withdrawn due the German Health dept and the drug manufacturer being unable to come to terms on reimbursement after the first year

Kiwi

Chrom. Agree in general re UK and the EU .
Re Alzhiemers ...I was looking at the inclusion / exclusion criteria for BRAVE

Inclusion Criteria:
United States Veteran eligible for VA care
Age 50-75 years, inclusive
Cognitively healthy

Exclusion Criteria:
Dementia or mild cognitive impairment on screening evaluation


Mild cognitive impairment excluded ?? I would like to see a study in those with mild cognitive impairment like Onrish did . Does 4 gms of V slow the decline vs placebo control ...also in 70-80's age group

Kiwi

Kiwi, thanks for your thoughts. My base case didn't include any of the stuff you dismissed and there is plenty of value in Europe alone. Looking at the launch trajectory in UK, I think it is going well but will take time. And Germany for me personally is not an IF but a WHEN. Not reimbursing would be tantamount to governmental negligence on a grand scale. JMO

Just doing a thought experiment. Assuming every country other than Germany approves V for reimbursement. Are there any examples where Germany is the only country to not reimburse a drug when all the other countries in the EU are?

Chrom. I think they just have to keep hammering away at the clinical evidence to gain wider access to the EU market .
More studies in select subgroups .
I had copy and pasted something from a link Dars posted ....NNT of 6 ??? to reduce re vascularization rates in Germany . How do you not follow up on that to at least try and gain reimbursement for secondary prevention patients ...especially revasc patients .

My other opinions
Don't expect any meaningful income from China . The generic's and Mocha's Epadel will dominate that market
The US ...I await with bated breath, N7's persuasive arguments on why we should dump $ staying alive in this market ...besides the 2 I mentioned in a response to him earlier .
Combos' are a waste of $ and time . Any new formulation would require extensive FDA trials
ROW market ....does everyone understand exchange rates ? My understanding is Vascepa is priced in US dollars ...so most of the worlds health care systems can't afford and won't pay for it .
Additional indications ... Dean Ornish ( who I've met ) has been looking into O3's reducing risk of Alzheimers ...have you looked into his work .
https://pubmed.ncbi.nlm.nih.gov/38849944/
https://www.cnn.com/2024/06/07/health/alzheimers-dementia-ornish-lifestyle-wellness/index.html

Kiwi

N7. Funny. So make the case for the US operations ...which I believe are running at a loss . The only 2 things I can see is the slim chance we get relief in the courts and the fact we need to sell Vascepa here..... even at a loss .....to avoid the penalties we would face cancelling our API supply agreements .
Kiwi

Thanks Captain again for posting the UK scripts. For me personally the 10% MoM increase in very encouraging. Based on my experience, full uptake in Europe takes 3-5 years vs. the US where share within class peaks after 12-18 months. I am curios to see what others think but for me the catalysts in the short, medium, and long term are the following:

Short term: (within the year)
1. remand of lawsuit back to lower court
2. Italy reimbursement
3. China CVD indication
4. share buy-back

Intermediate term: (1-3 years)
1. France and probably Germany (cant see how Germany opts out permanently in face of such strong, clinical evidence)

Long term: (+5 years)
1. Full uptake in Europe and healthy royalties from China and other partnered markets (while these contribute a small percentage to revenue, they contribute significantly to profitability)
2. Reformulated smaller pill or maybe combo for better compliance/persistence
3. Maybe additional indications outside CVD
(I don't think 2 and 3 are needed to drive value but it would be a nice upside case)

Curious to hear what others say. Again these are just my opinion.

RMB, I agree. Without AT LEAST two of those countries, we are dead in the water in the EU.

But it seems there is a legit shot at Italy and France. Germany, not so much. At least not in the next few years.

Kiwi, Your actually none of those things.
Sleven,

I prefer to be a realist ...not an optimist or pessimist .
Kiwi

Zip, I would feel more like you if we had Germany, France, and Italy in the fold.

Nope

Always looking for the negative in anything related to VASCEPA. I am an incurable optimist.

Zip
I am as optimistic, positive and enthusiastic as you are about the future of AMRN
So let me ask you what is your reasonable range of SP that you believe AD will sell the company for?
Tia

So they now have about 3,000 patients on Vazkepa ...out of an eligible UK population ...R-IT profile of 425,000. !!!
Kiwi

PS. we don't use the word Robust ...anymore since John Thero left :--(

Is/has AMRN ever been listed on the LSE.

Capt I was curious if your data allows distinguishing between NRx (new scripts) and refills?my guess would be no but just wanted to check. Thanks

From April 23 to April 24, 200% growth? Robust growth!

Capt...Vascepa is like a firecracker with a slow fuse... The fuse has been lit and it is smoldering...making its way towards the moment when it explodes.

Capt. I think in the UK sales reps can only see an MD on a sales call twice a year .
Conferences like the UK HEART and especially the recent one in Amsterdam (?) featuring presentations by KOL's like Dr Bhatt if possible ...is the way to reach prescribers

Follow up. Capt I can't find the quote on limiting MD contact to twice a yr but several references to MD's preferring more online contact instead ...following the pandemic
Kiwi

Thx Capt. Good example of why they need to dump the US market , conserve cash and concentrate on the UK / EU

Kiwi

No it doesn't . The price of the API is not the only consideration when competing in the US market
Kiwi

Thanks Capt. Slow and steady as she goes. Trajectory looks similar to pre-Reduce-it (MARINE) growth pattern in U.S.

The regional thing is confusing. Lack of scripts in London makes no sense. It still makes me wonder if the region represents where "buying groups" are located, not where the end consumers are located.

I forgot to show the geographic distribution of VAZKEPA scripts in England. 7-Regions are shown across the front with script numbers for January-April across the rows. In this view you can see the incremental growth for each region.

With the Southeast and London Regions being the most populous in England (9 million & 8 million respectively), it's easy to see where improvement in VAZKEPA sales is most needed. Also, note the estimated sales revenue for this year so far.

Hey Amarin, Increase your sales headcount in these two Regions!

Thanks Capt. Slowly V is gaining % of market monthly. 27% up to 34% since January. It would be nice to see a hockey stick growth as V continues to grow.
Thanks again for your efforts to keep us informed.

Captain, Thanks.
Sleven,

Thanks for sharing Capt Beer… nice MoM growth above trend line

Thanks Capt for the UK data !!

Pining away for amrn's play, desperate ghouls, investing fools, every week the same, truly insane

$AMRN Hello my Friends. English Prescribing Data for April 2024 is in. Here’s a summary and A link to my report for VAZKEPA® scripts:
Link: https://drive.google.com/file/d/1nknE5CBC1C58WfmmYLtqOp4YCiRBA3M1/view?usp=sharing
Summary:

VAZKEPA® Scripts (Capsules) continued grinding upward in April (210,256 vs. 189,380 in March). This represents an 11% increase over March. This is in comparison to a 2.84% growth rate for the entire Lipid Lowering Therapies (LLT’s) Market.
Slides 1-4 show the full dataset for each month in 3-Tables:

1. Total Market,
2. Omacor vs. VAZKEPA®,
3. Non-Statin Market

Slides 5,6 show the monthly growth rates for Omacor vs. VAZKEPA®

Enjoy

OK, makes sense

That will only be quarterly, unless the exceed 5% at any given time.

But each time they buy, they are then selling to Amarin, so they will likely never accumulate a large position.

JRoon, My opinion was included in my response. They are trying to eliminate Amarin"s ability to compete through reduced pricing. I also spelled out why I didn't think it would work. I don't think the generic companies had a choice, other than to file the complaint. I also don't think Amarin will have a choice if they win. The generic companies can't expand their market until 2039. None of them will be able to buy API in large enough quantities to significantly reduce cost. Amarin should be able to.
Sleven,

Can we see how many shares Cantor owns or does thaty come out in a quarterly statement?

Sleven, then what do you believe is their motivation?

JRoon, If the generic companies win the Sherman Act suit, what happens next? If the government determines that Amarin is guilty of monopolistic business practices, their exclusive contracts will be terminated. This would prevent Amarin from ever being able to compete on pricing. We know that undercutting generic wholesale pricing has been the strategy to maintain US market share. At that point the US market would be lost. What options would Amarin have then? The ability of the government to enforce the Sherman Act doesn't extend beyond the US boarder. Amarin can't afford to have those agreements terminated. The only choice would be for Amarin, to withdraw from the US market. Generic companies don't win by winning. All of the Sherman Act suits are being consolidated into the DRL v Amarin suit. With each additional plaintiff reducing the monetary reward for the companies involved.i don't see how a "money grab" would be a motivation. When the court assess monetary damages, it will be based on the generic indication.
Sleven,

Good to know, thanks Kiwi. I think what must be the case is that Amarin has been issuing shares on such a regular basis that it has triggered ongoing reporting.

Yes, Sarissa will be trying to sell the company while the litigation is ongoing, but the intrinsic value of the company is higher with the probability of a positive outcome (even in a settlement) than ZERO probability with no case at all.

Why would they sit around in court again for another couple of years when trying to sell the company? It makes no sense but then again you think they are shorting the stock to make money so by your theory a sale would not matter anyway. If they are just looking to make money anyway they can. I am surprised you keep buying more while per you denner is trying to drive the price down. Odd strategy. You went from Denner will sell the company for 15-20 a share to now they are shorting the stock to make money.

JR. some follow up on reporting share count
, UK companies do not have a regular reporting cycle for share counts. They must simply notify Companies House within one month whenever they issue new shares or have any other changes to their share capital

Kiwi

JR. Yes. Gr8 DD .....we would know by looking at their reported share count
Kiwi

Michael,
no?
<= 2.25/share, which would be a 300% premium relative to current price.

Kiwi, that might be true. However, Amarin DOES report their current outstanding shares on a weekly basis in the UK, so we would know by looking at their share count. Plus every time they sell shares (presumably to fund options), there is a filing in the UK.

JR. update / correction
[quote] A UK firm is not required to disclose if an agent is buying shares on their behalf during a share buyback.
The key requirements for a share buyback by a UK company are:

The buyback must follow the procedures outlined in the Companies Act 2006, including passing the necessary shareholder resolutions and board approvals.
The company can purchase its own shares either through an on-market purchase (on a stock exchange) or an off-market purchase (private contract with shareholders).

There is no specific requirement to disclose if the company uses an agent or broker to facilitate the share purchases on their behalf, whether on-market or off-market.

The company must have sufficient distributable reserves to fund the buyback.[/quote]

Kiwi

excuse double post

I think AMRN will want to carefully follow disclosure regs . If Cantor is buying on their behalf I think it will be disclosed if UK law requires .
If theres no disclosure by end of this week , then the buying we saw last week will probably have been a hedge fund front running the buyback
JMO
Kiwi

Also, I think the new SEC rule requires disclosure of daily transactions, but only on a quarterly basis:

Disclose on a daily basis for each buyback
transaction, quarterly or semi-annually
depending on type of issuer:
? On Forms 10-Q or 10-K for issuers using
those forms.

https://www.mayerbrown.com/-/media/files/perspectives-events/publications/2023/05/legal-update--sec-adopts-new-share-repurchase-disclosure-rules.pdf

Right, but is that after Amarin buys shares from Cantor, or when Cantor first buys them?

My point is, could Cantor hold onto shares for a while before selling them to Amarin? Or if we don't see a disclosure in another week or so, is that confirmation that they have not yet bought any shares?