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Don't underestimate the shade Dr Nissen has spread ...it reaches far and wide .
Kiwi
Ha Ha ...oh jaded one
Kiwi
Inadequate presentations maybe? Or a lack of confidence by KOLs? Lack of confidence caused by inadequate presentations?
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
Re
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
I will welcome others to correct or educate me, but my thought as to an answer to your question is that beyond approval and a thumbs up for reimbursement, the company still needs to launch, market, and educate to gain sales. Just because Vazkepa is written down in some book that it is now being reimbursed for doesn't mean docs automatically start writing scripts for it. Except for New Zealand, there is no advertising for drugs in these other places and it requires some get out the info by the company. That is why it has always basically been understood that Amarin couldn't launch V around the world by itself and needed to be bought out. Heck, 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.
Sleven, Looking for a fight - as always' ! Not enough bashing Stockboy any more ?
Cant you just 'be offended' again - and take a long break - more peaceful here then !
Why don’t we have any sales is places like Australia, New Zealand, Netherlands, Sweden, and the Asian pacific countries? I thought we had approvals in all these places yet only sales in Spain and England. Seems like Spain got up and running quick but I hear nothing about these other countries. Sweden was approved two year ago.
In the Netherlands, the Dutch Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients with established cardiovascular disease and elevated triglycerides (≥ 1,7 and ≤ 5,6 mmol/l).Aug 9, 2023
In the first national reimbursement deal Amarin has signed in Europe, Sweden agreed to cover the drug for statin-treated patients with established cardiovascular disease and elevated triglycerides, Amarin said Monday. Vascepa is branded as Vazkepa in Europe.
The Swedish reimbursement price, at 1,640 Swedish krona (about $175) per month, meets expectations and is high relative to the drug’s U.S. net price after discounts and rebates, Cantor Fitzgerald analyst Louise Chen wrote in a Monday note.
oh oh... someone touched a nerve. If you can't stand real posts that point out reality, then why don't YOU pack it in? Sell, and do yourself a favor. Release yourself from the mistake and move on!
Look at the bright side, if you sell, you won't have to pay long term capital gains taxes.
Jasbg, Incorrect. I still find your ignorance offensive.
Sleven,
Interesting technology for delivering OMG-3 FA along with Atorvastatin for Improving bioavailability and antihyperlipidemic action!
Who owns this IP??
https://doi.org/10.15171/apb.2019.031
Kiwi, l don't think any more studies are required. The scientific committee understands the value of icosapent ethyl. This is not my opinion. I make this statement based on medical treatment guidelines. France and Italy have both backed Vazkepa. They just don't want to pay for it. I do a fair amount of reading. To me this looks like an economic issue, not a scientific/medical debate. Eventually the math should resolve this in our favor. The cost of prevention is less than the cost of post event treatment. Germany never had any intentions of reimbursement. I base this on the comparator drug. They will avoid the expense as long as they can. Eventually they will be forced to pay up. The adoption of new medical therapy is a top down process.
Sleven,
Jasbg, this is an odd take. Not sure how you come to this conclusion. It's OK to support Denner and Sarissa. But let's get real. With (relatively) steady cashflow, $300M cash, and no debt, how would a company go bankrupt in one year?
I will certainly acknowledge that Sarissa moved much quicker to cut expenses than prior management did. But beyond that, Sarissa is basically following their playbook. Most of what has been "achieved" (approvals, submissions, partnerships, etc.) were already in motion when Sarissa took over.
Interesting response, Caddie. I was just giving my take on future BO potential, and why Denner wouldn't sell the company yet. If I offended you in some way, feel free to just skip over my posts.
Kiwi, first off, I just picked kidney disease at random, as an example. I don't know much about it, to be honest.
As far as buyout estimates, I am clearly working with a lot of unknowns. I have no idea what revenues will look like eventually. But I look at what has happened in the U.S., Canada, Spain, etc. to help predict what would be "easily achievable". I also don't know what hurdle rate a BP would apply to Amarin revenues. Generally, with less clarity and more risk, a higher hurdle rate is used. With more certainty and less risk, a lower rate can be applied. This is why Denner would never sell today - there's just too many unknowns sitting out there for Amarin. I think once they can get Italy and France on board, get greater traction in UK and China, and possibly achieve more certainty with U.S. revenues (not sure what that would look like), then a BP has a whole lot more to work with.
Oh, and with regards to "Enterprise Value", you would include A/P in the debt number (short term debt). But EV is really just a calculation. It doesn't represent a BO estimate.
No argument on the “as much as he can get” statement. Who wouldn't?
But don’t lose sight of the fact that Denner and the board are also compensated by AMRN. I suspect the board members were chosen to vote however Denner tells them to vote and they bring no real value to the company.
I believe in pay for performance. If share price is an indication of performance, they deserve $0.
Sleven, Saw 'you stopped' being offended - and like Whala (20.000+ posts - without shares) spreading your endless wisdom again !
You have an impressive memory Kiwi…yes was at ZSPH through the acquisition and two CRL’s followed by shuttering the San Mateo site. AZ paid 2.7 b for us; Lokelma was the superior drug for hyperkalemia due to rapid lowering of K+…they were projected to do a billion at peak and are at 400 now so many years after because of the delay in launch. Goes to show, all things being equal, market order entry goes 50- 60% share for 1st to market, 20 to 30% for second and 10 to 20% for third.
Back to AMRN, I have seen again and again that ultimately the science will prevail. Still long 92K shares.
“A short trial or study that will convince the remaining big 3 EU markets the Vazkepa will reduce events and save them Health Care Euros.” REALLY ?????
No matter how many ways you try the spin the same thing again and again, it’s not gonna happen. Thinking that a short trial could convince them when the landmark reduce-it trial could not, is just a ridiculous thought. Do you think they are a bunch of infants or toddlers????
It is purely your own fantasy that a short trial is magical key to getting endorsements in Germany, France and Italy. Forget about Amarin, even health officials from Germany, France or Italy do not believe it.
BP BO
I see lots of comments about this , but honestly which BP would be best to purchase AMRN? Anyone with comments or answers on this?
Kiwi, I will get beck to you to tomorrow.
Sleven,
N7. I'm assuming Denner is acting in his best interests which hopefully align with ours ...altho Tats posts ( re Denner short selling ) has made me question that .
On balance I think we want the same thing ...a higher PPS for AMRN
Re Jasbg posts ....I basically ignore them which is unfortunate . He posted some great Playing for Change music clips ( one filmed near where I live ..and featuring someone I'd met as a neighbor ) ) which I enjoy.
Music may bring us together when all else fails .....hopefully not wishful thinking .
Hope AMRN works out for you
The current period reminds me of 2014
Then PPS was under $1 and AMRN committed to finishing the R-IT trial ...which main stream Cardiology expected to fail.
We need the same " we'll prove it " in the EU . A short trial or study that will convince the remaining big 3 EU markets the Vazkepa will reduce events and save them Health Care Euros.
We're against the ropes ..just as in 2014
We need bold moves and we have some time due to the EU patents extending out to 2039
JMO
Kiwi
Any BP with a CVD portfolio can add Vascepa/Vazkepa in a heartbeat to drive sales. The USA is still worth billions as is the ROW and EU. This isn't about naively trusting Denner, Holt, or the BOD, this is about everyone on board wants to make a ton of money. You buy Amarin shares because you think you can make a ton a money. Plain, simple, fact. All risk assumed. A savvy investor only needs to score once in biotech land to walk away with millions. My money remains on the Vascepa/Vazkepa enterprise. And I accept all risk.
I have to laugh at this post because it implies something I do not. Denner, Holt, et al at Amarin all want what I want. To make as much money as possible. Myself, I don't think Denner is awake at night thinking about investors, but I do think he wants as much as he can get. Here's my point: I'm happy to ride his coattail because I doubt I'll be disappointed in the end, and I know all about risk. Thanks!
Kiwi, No disagreement. Some posters here seem to think that because Alex Denner is a billionaire biotech investor, he can do no wrong. He must be acting in the best interest of the average shareholder. Factual information of prior misdeadeads will not change their minds. Does that remind you of any other currently relevant situation?
Sleven,
N7. as you know ...there is no way AMRN fails to exist with $300m cash on hand near term ...even if they were losing the same amount of $ they were with prior mgt.
Many of us may have our reservations about Denner ...but at least he has stopped stupid waste of the Co's resources .
Kiwi
Jasbg, You went to school on the short bus, I assume.
Sleven,
the_kube, Have to say - that is absolutely living outside financial reality.
-------------------------------------
Without Sarissa and the 2023 Proxy - Amarin might (not unlikely) have been already history today !
Do not forget: New patents in suit(s) in Delaware (and New Jersey ?) that are presumed valid. Present CAFC appeal by Amarin only involves infringement issue now; the CAFC decision/opinion will be important to Sarissa/Denner/Holt.
IMO the BP that acquires Amarin..will have Vascepa PLUS new EPA meds and new indications to pursue and the time to pursue them.
JR. excellent post . Interesting that you referred to kidney disease ...your analysis was spot on .
Great example was the development of drugs to lower high serum potassium ...ZSPH and RYLP . One of the poster here Chromosome ? may have worked at ZSPH at one time .
My wife has CKD patients regularly having episodes with high serum K . Many would end up in the ER and event rates were somewhat predictable .
ZSPH and RLYP developed a drug that patients could take to lower serum K and both companies were brought out by BP's
RLYP got to market first with Valtessa .
I still don't get your buyout estimate for AMRN . Where do you see short term debt ? AMRN says no debt .
Co has shrinking margins , 41% decline in US sales of Vascepa , very limited sales in the EU with no assurance that the remaining big 3 EU markets will reimburse.
No reason for anyone to buy this Co as things stand.
The only plus I see ...and the reason I recently invested in Co is the EU patent extension out to 2039.
But so far Co has failed to show any vision on how to take advantage of this, beyond the same ol same ol
Kiwi
I would think that the extension of the European patents to 2038 is the large enough window that Amarin needs for an eventual sale to a European pharmaceutical company. Now, it needs to secure Italy and France and get some price deals in places like Greece and Portugal under its belt. Then, it needs to show a trajectory of script growth in countries like England and Spain so a potential buyer can make projections about eventual sales. It would be nice if we could get something positive out of the BRAVE trial or the introduction of the Combo pill or something to make the company more appealing to a buyer. Then, it'll be important to unload the company next year sometime or in 2026 at the very latest so a buyer still has plenty of patent time to make money.
Why don’t you just f’in sell and go buy shares in Wall Mart or McDonald’s. You are beyond tiring. Who is your intended listener on these message boards, Mother Hen?
Regardless , there was relatively little volume yesterday and I did add on a few shares yesterday at $0.83. If it was that bad, the volume of selling should have been at least $15-20 million shares, It was not.
You are right. We have 15 years of exclusivity. It has not, not yet, been priced correctly.
Really..that’s of concern?
Enterprise Value is a financial/mathematical calculation, not a valuation model.
The 2039 exclusivity was huge news and I don't think it was recognized enough by AMRN Longs. Adds big value to EU IMO
The hurdle rate that a BP would use for "maybe" revenues is so high that it places very little value on those future revenue streams. And determining those revenue streams for a DCF calculation is difficult because Amarin is in the unenviable position of already broadcasting to the world that uptake is very challenging for Vascepa.
In other words, we actually have to at least get approvals/reimbursements done for a BP to buy-in to the story that Vascepa has legs.
The issue most investors miss in the BO calculation, is that BP's (or buyers of any company) value certainty over risk, and a clear path to revenue. This is why Sarissa will not just sell the company now. Because a BP simply won't place much value on "unknown" future revenues, especially with the headwinds that Amarin has put in place.
This is in contrast with a phase 3 drug, where a BP will be 100% responsible for the "buildout".
To put this in better context...BP seeks to buy a phase 3 drug used to treat kidney disease, that has just cleared final FDA approval. They know the number of folks impacted by kidney disease. They know what the historical uptake is for other kidney disease drugs, and how much people pay. They can extrapolate out those numbers to the new drug. Compare to Vascepa, where they really have no idea what could happen, because in addition to losing the U.S. patents, they face headwinds with worldwide approvals AND uptake, and also face headwinds because not all members of the medical and scientific community are on board with the efficacy of EPA (thanks Dr. Nissen). This all equals RISK, which they do not like. So even if they make an offer, the hurdle rates will be astronomical.
So this EV assumes no values for intellectual property and current stream of sales revenue?
I don't think Yahoo considers short-term debt in its calculation (which it should).
This would put EV at around $300M~ish (debt and cash essentially offset each other for Amarin).
Because Amarin's cash typically offsets its debt, Market Cap is usually a reasonable proxy for EV for them.
MrMain, that has been the question that has consumed us for quite a while now. Many feel that Amarin has to first get things rolling (in the EU primarily) before convincing a BP to consume us. Of course the other option (although probably harder to convince BP) is to market V's potential to BP now. The latter course will obviously bring much less in terms of a sale price, but the former tactic runs the risk of Amarin botching growing V enough to entice BP, and I think we can all agree that BP would be able to extract value from V much quicker. Luckily we have gained a few more years in the EU as far as protection goes.
Many here (probably not you or I) would be upset if Amarin sold itself now at a low price, but for now, I think that is a low probability as I think Denner is looking for more remuneration for his trouble. Of course if he sees the light at the end of tunnel dimming he may change his mind and want to get out with his skin intact.
Those hurdles are meaningless, as in a buyout, 100% of his options vest immediately at whatever price the BO occurs at.
They only have value if he chooses to exercise his options BEFORE a buyout. But why would he do that, if theoretically the buyout price is the highest price we ever see?
In other words, those hurdles were put in place to placate investors, and make people believe that Holt had specific targets he is trying to hit (of course, he likely DOES have his own targets in mind, AND he wants to get as much as possible).
Fair points. For what it’s worth… I selfishly wish for the success of AMRN and don’t really care who’s in charge when that happens. I hope such success manifests in the stock price. But, just like KM, good will has a shelf-life and for me Holt, Denner, the other board members and Sarissa and is quickly approaching that expiration date.
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