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Triple88
Thanks
Lots of questions
Canada and HLS vs EU: keep in mind Canada has a different system than most of EU. We have a hybrid private/public drug coverage. Seniors, ppl <25 and unemployed/welfare get most meds free. Working people have health plans through work that are required to cover based on Health Canada approvals (with exclusions) but the funnest exclusion is that they exclude themselves, the government. Private insurance covers V for DM2 and secondary prevention based on Health Canada approval whereas the government only covers for secondary. Also, healthcare is provincial so each province is different (not sure BC even covers it yet). Governments and private are putting up more obstacles like prior approvals and recent lab data as a way to pressure HLS to drop their price. EU will be doing the same. Prevention just doesn’t get attention because you don’t see the results. Bureaucrats in German and Italy know it works but starting preventative therapy a year or 2 later won’t cause obvious harm and EVERYBODY is only focused on the current budget. It’s always just about the money.
V should pick up faster in EU than Canada because for the first 18 months it was only covered by private. EU will start off stronger.
What needs to be done? Great question. I’ve been trying everything I can think of locally with limited success. Docs are starting to come around but it’s been tough.
I previously listed the obstacles I’ve faced in response to Capt.
People never quit their pain meds or sleeping pills but a statin or V where nothing happens when you stop - that’s a different story.
The stock trading has been weird today, I’m a little nervous about cc. I think we will have a drop in cash but the extent is the worry. Denner has been a complete ghost, I’m really hoping he does something soon.
Nuke
V has been available in Canada for 3 years so I have 3 years experience dealing with prescribers and the obstacles.
11 years in Amarin purgatory
Capt
Unless the increased discount happened to all insurance companies prior to the start of Q2 or at most the early weeks of Q2, people should be prepared for another drop in revenues.
Also, product launches are expensive so as things progress in EU (eg Spain) you can expect increasing expenses while also expecting a slow uptake. Doctors are VERY slow and resistant to changing the medications of a Pt for a number of reasons: 1) taught to use the lowest effective dose/drug & avoid adding unless absolutely necessary 2) minimize pill burden 3) if it’s not broken, don’t fix it (and V doesn’t “change” or fix anything 4) no GP wants to be prescribing CVD meds for their pts who have a cardiologist because that’s the cardiologist’s job (except that many cardiologist feel that lipids and BP management is the GP’s job because it’s simple and time consuming).
Prevention just isn’t a priority
This has been my personal experience over the past 3 years.
I don’t see anything positive coming out of the cc but the fact Amarin has blindly followed XBI for the past couple months (thanks to FFS’s chart) reassures me the current SP is a function of the market sector and not a specific problem or impending doom of Amarin operations.
As always Capt, we have to continue to wait.
FFS
Thanks!
So not just a broken stock with no support, it’s a broken sector.
I feel much more comfortable knowing the primary driver of Amarin’s demise is the the Biotech sector (and of course, Denner not having a single person in the executives or Board that has any experience AT ALL launching and selling a cardiovascular drug in EU).
FFS
Just out of curiosity, could you post that same chart with Amarin and XBI together?
Thanks
Mark
Canes
“My prediction is Sarissa runs this back over a dollar before that comes to pass.”
The notice is a meaningless formality. Amarin would have 6 months to respond or comply.
FFS
Just to clarify and avoid any panic, the delisting process would take a minimum of 6 months, during which they only need to return to $1 for 10 days. Surely the all powerful Saint Denner can manage that. The very small possibility of a “going private” scenario should be enough to ensure enough short covering to resolve the delisting concerns.
“Involuntary delisting occurs when a company fails to meet the minimum listing requirements or violates other rules set by the exchange. Once a deficiency notice has been sent, the company has 90 days to comply with the continued listing standards, or 180 days if the violation was for a sub-$1.00 share price. In order to be compliant, the company’s share price or market cap must rise above the minimum for at least 10 consecutive days in the 90-day (or 180-day) period”
I do completely agree that shorts will be losing interest with the new low being hit, especially with so many other more vulnerable stocks out there with exposure to the market instability (interest rates/bond market/debt etc)
Don’t forget, if JT hadn’t pumped the stock in July 2019 and then diluted to raise $200M 2 week later at $18 this company would have been bankrupt 2 years ago.
Hindsight is 20/20. He kept the company afloat when the FDA screwed them by moving the goal posts.
For those interested in the science:
The attached podcast is very heavy on the scientific lingo but it is a “must listen” for anyone interested in the science and future potential of V.
Note: IPE/EPA is converted to E-Series Resolvins (E1, E2, etc: as a group are called Specialized Pro-resolvin Molecules or SPM) which stimulate the resolution of inflammation. The guy being interviewed is Prof Serhan, the Harvard scientist that discovered Resolvins. The podcast is blatantly sponsored by fish oil supplements and a lab that sells tests so they go to great lengths to NEVER mention V. They constantly slam the evil “Big Pharma” and advocate “doing what’s best for the Pt” yet never mention a proven, high quality source of the very topic of the podcast.
The guy clearly believes Resolvins (and therefore the precursor EPA) will be effective in Alz, rheumatoid arthritis, brain injuries, depression, and several others.
He is involved with a startup biotech trying to produce specific Resolvins.
https://podcasts.apple.com/ca/podcast/dr-kara-fitzgerald-new-frontiers-in-functional-medicine/id1103271110?i=1000624815219
Functional medicine is a new branch of medicine that focusses on prevention. Their focus is on the underlying causes of disease, using diagnostic tests, lifestyle changes, diet, exercise, and other natural remedies as the drivers of prevention. It’s becoming clear to me that practitioners of functional medicine are “naturalists” and against pharmacotherapy beyond the basics of statins and blood pressure meds (only when all diet and exercise options have failed). It’s so unfortunate that nowadays every aspect of life has become an “us” or “them” issue and open minded people are pushed out by special interest groups with money and power trying to get “their” agenda out.
Kiwi
You realize “Dr Alo” isn’t a medical doctor right? He is a DO - Doctor of Osteopathic Medicine.
“went to medical school in Chicago at Midwestern University’s Chicago College of Osteopathic Medicine.” He specializes in osteopathic cardiology- whatever.
He’s a social media quack
He talks BS and controversy because that is what gets him attention. Don’t give it to him.
Capt
Did @DrLipid actually “like” and EPA related post? If so: un f@cking believable that he has actually acknowledged EPA as a therapeutic, let alone like it. That guy’s stubborn resistance to ANYTHING other than ApoB is unbelievable.
Laurent/NS/Dogn/JRoon/those interested in the science:
Here is an edited video of Bhatt at ESC. Had to chop off the first 5 minutes (basic R-IT background) and at the end the audio and video aren’t aligned but that is how it was when I watched.
https://drive.google.com/file/d/1SeBlpk658eAuADfhhj71L5gGyXDLxyec/view?usp=drivesdk
Bottom line: “it’s the EPA stupid” and more specifically the ratio of EPA to AA that drives the benefits of V.
Supports my theory from 3 years ago that our over consumption of Omega 6s in corn and soybeans has thrown our immune system into disarray. This is very good news because it implies that other inflammatory conditions will benefit because it’s not specifically targeting cardiovascular dysfunction.
The imaging data from the reevaluation of the EVAPORATE trial is very supportive of BRAVE which has cerebral blood flow as a primary outcome.
https://drive.google.com/file/d/1m86Nb-CaPL-uuUCm-RfqNopk1w5Sq1ts/view?usp=drivesdk
Tatsumaki
Your thoughts:
I find it very “odd” that on the 1 day where the SP dropped below $1 for a short period , and while only 9 million shares traded, AD was able to buy specifically 2 million (exactly) shares (net, after any selling to drive it down) at exactly $1.
My suspicious nature of AD leads me to think he was, via some third party, in control of that transaction from BOTH sides. Who was selling a sizeable 2M (22% of the day’s total) shares at the stock’s multi year low? I realize it wasn’t necessarily a single transaction and that “dark pool” accumulation was likely involved, but it just doesn’t seem practical.
It doesn’t pass the “sniff test” IMO.
I guess we can assume no BO on the way in the next 3 months or so, AD can’t be talking deals while buying stock. I guess the path is now very clearly GIA (just like everyone has been expecting with the great blue wave of finally having a management that knows what they are doing - even though they no longer have a SINGLE member of management, Board or Executives, who has ANY experience in launching a cardiovascular drug in EU).
No wonder WS is willing to sell at $1
Capt
From my research, keeping your EPA:AA or Omega3:Omega6 (related, but the first is more accurate IMO) at 1:3 or lower (1:2 or ideally 1:1) is the key.
For 1000’s of years it is believed the Omega3:Omega6 ratio was around 1:1 but in the past 100 years it rocketed to 1:20 due to the rise in corn and soybeans.
My ratio is 1:1.2 by avoiding corn and soybeans, eating grass fed beef and limiting carbs.
Rose
In the summer of 2021 I had a 1 on 1 video call with Dr Bhatt. We talked about my EPA for COVID paper in which I hypothesized that it was the substrate ratios of EPA and AA at the COX and LOX enzymes that drove the inflammatory response and damage to the body. I pointed out that he had all the EPA and AA data from R-IT and asked if they had looked at the ratios and the effects on outcomes. His response: “there is no plan to do such an analysis at this time”. If Bhatt didn’t think the EPA:AA ratio was important at that time I assure you Amarin could not have marketed it to physicians or Pts that way at the time. Can’t blame JT or KM, it was Bhatt that didn’t act. BP would have been the same.
A few months later I asked the same question to Bhatt’s former boss and mentor Dr Peter Libby. I was able to record that question and you can see from Dr Libby’s response that it was only an unproven theory at the time.
https://drive.google.com/file/d/1xi1vrPEUOukORL2BCoExg_g9mqjPP-Nc/view?usp=drivesdk
Also, if the marketing angle would have been “the EPA:AA ratio is the cause” then any DS would have been seen as a less expensive alternative to bumping up your EPA level.
Focus on the good points: if it’s the EPA:AA ratio controlling inflammation that caused the benefits in R-IT then it further supports the hypothesis that V will be beneficial in several conditions that are driven by systemic inflammation (Alzheimer’s for example)
Kiwi
“Is that a correct assessment of your views ? “
No
I’m confident governments will cover V (unless they are in a really bad economic situation like Germany and Italy) but I think it will be a slow growth in sales because prevention isn’t a priority and because without measurable biomarkers it’s a tuff job to convince doctors and Pts to use it.
Amarin has to maintain sales in the US long enough for EU to become profitable, which is at least a year away. So far it appears the exclusivity agreements KM negotiated are doing the job. Let’s hope the new crowd can keep things going for the new contracts for 2024.
NS
Yes, thanks for the link.
As usual, insurance companies don’t give a crap if the drug benefits you or not, their goal is to avoid paying wherever possible and to put up as many obstacles as they can legally get away with.
Kiwi
Forgot: you also asked for a link to his presentation. I could share his presentation but I would have to spend time editing the video to protect my source and I just don’t have the time (nor the editing skills).
Key point: It’s the EPA:AA ratio that is responsible for 65% of the benefits. Bhatt also said that in an absolute “worst case scenario” the RRR would be 20%
I believe I posted the biomarkers
https://drive.google.com/file/d/1NU8NZ7XMSp2G8PwItlzOuOL8ovsdwDeh/view?usp=drivesdk
And the conclusions
https://drive.google.com/file/d/1Y8_TvccrxwZ1HBx4zbCb15BVU0ScJv94/view?usp=drivesdk
Kiwi
“Re governments not paying
They are falling over themselves to pay for Semaglutide ? ( Ozempic ) “
Not quite the truth nor is it apples to apples.
Ozempic, approved several years ago for DM2 is covered by government insurance. Not “technically” covered for weight loss but physicians can prescribe off label and the government can’t tell the indication.
About 3 months ago many of the main private insurance companies announced they will no longer cover unless documented DM2 with treatment failure on a list of other drugs. They are NOT falling over themselves to pay. They are trying to not pay but got caught off guard with the Pt demand caused by Hollywood endorsements.
Another BIG difference: Ozempic causes immediate and measurable changes in key biomarkers (HgA1C, daily BG, and the pts weight) all of which the Pt cares about (generally).
V doesn’t change anything. If it works perfectly nothing happens. Much harder to motivate Pts.
Night and day comparisons
Orbapu
Last weekend Bhatt very clearly called out that study. As I mentioned on ST:
Bhatt went out of way (off topic completely) to totally slam Nissen without mentioning his name directly. IT WAS BEAUTIFUL TO WATCH!!! He then went on to OPENLY and DIRECTLY call out the editors of the journal that published the inflammatory biomarker study. He clearly pointed out how intentionally misleading it was to use RELATIVE increases and ignore ABSOLUTE increases, pointing out that some of the relative increases were smaller than the specificity of the testing equipment.
There are only 2 people left who question the R-IT results: 1) Nissen (because, IMO, the US insurance lobbyists paid him a lot to throw some shade on the results. If nobody countered the strong results with a p<0.0000001, then insurance companies wouldn’t be able to justify refusing to cover, which they did purely to save money) and 2) Kiwi (because he likes to argue)
Government payers all know and believe the R-IT results, they just don’t want to pay (can’t afford it in their budget). Paying for prevention only helps the budget in 3-5 years.
stockBOY
Ok, so you have no medical background or knowledge. Got it
Mivan
“I can't understand some of the logic in the chart:
If Vascepa is prescribed for Cardiovascular Disease and patient has TG ≥ 500mg/dL, he will be denied unless he has gone through fibrates before. Do I read this right? “
If TG are over 500 the Pt likely has a different medical condition (VHTG) which has a different origin (involving abnormal chylomicrons, which shuttle fat absorbed from the GI tract to the liver) instead of VLDL which shuttles TG and cholesterol from the liver to the rest of the body (except CNS).
Both Lovaza and fibrates are more effective at lowering TG at these very high levels so they are the preferred choice.
Most Pts with TG over 500 are unlikely to get their TG level under 150 with either of those therapies alone. They need dietary changes and likely additional medications like V later on.
Michael
That makes no sense. V was approved for all of EU years ago. KM hired sales staff for Germany when they were scheduled to launch (already approved). The law changed after the launch had started. The sales staff were on short term contract to be renewed once reimbursement established.
Hayward
You don’t appear to know what happened in Germany.
Germany has always allowed drugs to launch with the price the manufacturer decides for the first year. During that year the company and government negotiate a price. You can start selling on day 1.
Due to COVID, a war next door and very bad economy the government changed its policy and suspended new drug launches with the exception of certain acute or critical circumstances (preventative therapies did not qualify). So AFTER the planned hiring and launch the German GOVERNMENT changed the rules and V was not covered. Nothing KM could do about a NEW LAW BEING PASSED.
Later the scientific approval guys decided V was the same as ezetimibe and therefore reimbursement LAWS prohibited reimbursement above generic ezetimibe ($30/month). At that point KM fired everyone and left Germany.
They changed the rules in the middle of the game.
Do some research before ignorantly shooting your mouth off.
Lizzy
$0.96 yesterday. Saint Denner is doing an amazing job.
They need to offer KM those extra 20M shares to come back and salvage the company
Johnniegalan
I would only support an aggressive marketing campaign to sell in EU for ASCVD. New indication would take many years and only have a small benefit in the final years of EU patents.
Zero benefit to any new indication in the US. US insurance receive a PA stating the Pt needs V for the patented CVD indication and they give them gV with zero legal worries. Wouldn’t be any different for arthritis or COVID or Alzheimer’s etc.
We have $300M in the bank and cash flow neutral. We don’t need more cash. This is just AD taking a bigger percentage of Amarin for really cheap at the expense of retail. We get diluted, he get greater ownership
JRoon71
Diluting at a 5 year low in SP while having $300M in the bank and cash flow positive would be criminal. I would hope the other HF invested in Amarin would try to stop it. I have no faith the SEC would be of any use but he would be screwing a lot of HF as well.
Johnniegalan
Shareholders have no say in such a transaction. Denner was gifted 100% control. The “shelf” in the previous AGM, for which we had no cc because the original cc failed to meet quorum (never seen that before) gives the Board the right to do whatever they want with an additional 100M shares.
Amarin is now Denner’s personal company to do with whatever he pleases.
S3
Preferred shares going to Sarissa????
Denner sells himself 100M shares at $1 and ups his ownership to 25% of a very diluted company???
Jasbg
“You have repeatedly shouted from the hilltop - that Amarin after Proxy is run by completely unqualified people
And now you go and buy in the company - you have told everyone is rotten to the core !”
Yep. Those are fairly accurate statements.
Regardless of the incompetence and dishonesty by Saint Denner and Sarissa, I still think V is a valuable asset and that Amarin is worth more than COH plus inventory so I bought some shares. I also believe in “buy when everyone is selling, and sell when everyone is buying” to some degree.
$0.96 proves WS has no faith in the great blue wave. WS also has no patience, I do. I bought knowing it will be a year or 2 before SP reflects the value of V.
6 months ago it was absolutely unforgivable that the SP was below $5 under the old Board. They were in their positions for 6 months and failed to achieve quadrupling of the SP. Now everyone is fine with the SP dropping below $1 and having had 6 months with the new Board, claim they are prepared to wait another year. Those people are the hypocrites.
I’m not related to KM but he clearly had more relevant experience than the current CEO.
Full disclosure: I did buy 4,200 shares today at $1.03. The companies has a hell of a struggle to stay cash flow neutral while launching in EU but and evaluation of COH plus inventory was too much to pass up on.
I still believe we have at least another year before SP sees any significant increase.
It will get sold but I’m sure most will be disappointed with the accepted offer. AD will make a good profit but we will only know about a fraction of what he made.
What did he say in his latest PR- I must have missed it? So much more transparency with the bankers in charge (100% in charge)
Kiwi
“but his opinions on KM and PCSK9's are shall we say "poorly informed "
Spent 2 hours with the Amgen rep today who drove 2 hrs to meet with me. We discussed all aspects of Dyslipidemia/CVD prevention. He shared stats and his in-depth knowledge of worldwide use. In the pharmacy I manage we do not have 1 single Pt on a PCSK9. Zero
I’m pretty confident in my prior statement and feel more informed than most.
Your clinical trial of 1 and your personal expenses as a FH Pt with good private insurance is not typical.
Free Crestor? Wow. Most of my Pts have to pay $4.10 for 3 months supply. KP must really care about your health as their first priority.
Aren’t you working on getting the MITIGATE data released for the critical “US data to confirm R-IT” because somehow RESPECT, JELIS, EVAPORATE, CHERRY….. don’t count if not done only on US Pts?
Zero concerns about the science. Just every payer wants to avoid paying and needed Nissen to give them some bogus theory to allow them to justify not paying.
V has been in the US for 11 years, ASCVD approved for 5 YEARS and US insurance still fighting to avoid paying.
ITS ALL ABOUT THE MONEY
Johnhancoque
Neither KM nor Saint Denner are GIA because they want to. They have no choice but GIA until someone makes an offer. Nobody wants to buy Amarin. That’s reality.
Healthcare budgets are maxed everywhere. Systems are struggling to meet the acute care crisis of day to day care. Prevention is a low priority compared to an MI in the emerg. Accountants don’t care about saving $50,000 in 5 years if it means spending an extra $3,000/year until then. The budget in 5 years will be somebody else’s problem.
PCSK9i are the same thing. They are amazing drugs that are hardly used for the same cost reasons.
Prevention is a very hard sell. Thus, no interest. Novartis learned their lesson with The Medicine Company, overpaying for a drug they can’t sell. But at least they also got IP with that purchase. No such luck with V.
Bid
And now the company has absolutely nobody with any experience whatsoever in launching and selling a Cardiovascular medication in Europe. Nobody in senior management, CEO, or on the Board. Nobody with any experience at all. No shortage of bankers and HF buddies, but nobody who knows how to execute a biotech launch, negotiate coverage or launch marketing. Nothing. KM had 20 plus years of experience. Laurent had experience as well. Now we have a guy with a PhD in supply chain management running Europe. Do you feel more comfortable now?
Stop lying to yourself. Amarin is much worse off now than they were a year ago. And the stock price clearly reflects that.
Always
I really hope I have to but considering they have not done ANYTHING positive half a year later I’m not too worried.
Zero communication
Failed to have quorum for AGM (first time I have ever heard of that happening)
Released unaudited financials while announcing a new CEO so that they didn’t have to face a cc
Quarter ends with no cc - unbelievable
Preparing to hand over a huge piece of the company to themselves
A Board of unqualified people
Zero change in plan
I just can’t find anything to give me any confidence that as a shareholder I should be comfortable with AD in charge (especially with 100% control, zero accountability)
Canam
Denner has conned retail into handing over 100% control of the company and now he is going to arrange a sale where he makes a fortune and retail gets screwed. Try and convince yourself that Denner is doing something positive for anyone other than himself if it helps you sleep at night but it’s pretty clear to anyone with their eyes open that he pulled off a huge scam and will walk away with all the money.
You are in absolute denial.
Over $300M cash and stable COH and yet they are handing over a chunk of the company -why?
KM and the old Board could not possibly have done worse to shareholders than AD.
Tat
Agreed
JRPac
Ouch! Thanks for the bigger picture.
Maybe Holt was brought in to sell Amarin to a private equity company (who ???) for 300M in a year? Amarin is not going to be making any real profits in EU for the next 12 months so Saint Denner can just keep Amarin struggling to stay afloat long enough for retail to get fed up and bail at a huge loss. That sounds like Denner being a very smart activist investor- making himself rich and screwing everyone else.
Considering it takes about 2 years after a final reimbursement decision for a new drug to get accepted and incorporated into the routine prescribing habits of doctors, Amarin is going to have to fight to stay alive for quite a while. I’m sure Denner is prepared to patiently wait for retail attrition before handing HIS COMPANY, which we handed to him, to his private equity fund and making billions in profit.
I have been unable to find anything at all in today’s information to give me any hope or optimism.
It would appear Saint Denner’s approach is to maintain sales by throwing V in the discount bin.
Race to the bottom against several generics with no overhead.
Ride the blue wave!
Kiwi
Just FYI (no criticism, just an interesting clarification on a common misconception) on the “do no harm” idea: it’s not actually in the Hippocratic oath.
Also, often to do nothing is the most harmful act (like not prescribing V due to worries about Afib, something a local MD constantly falls back on to avoid actually doing something for his Pts).
From the Harvard Press:
https://www.health.harvard.edu/blog/first-do-no-harm-201510138421
As an important step in becoming a doctor, medical students must take the Hippocratic Oath. And one of the promises within that oath is "first, do no harm" (or "primum non nocere," the Latin translation from the original Greek.)
Right?
Wrong.
While some medical schools ask their graduates to abide by the Hippocratic Oath, others use a different pledge — or none at all. And in fact, although "first, do no harm" is attributed to the ancient Greek physician Hippocrates, it isn't a part of the Hippocratic Oath at all. It is actually from another of his works called Of the Epidemics.
So why the confusion?
Admittedly, there is similar language found in both places. For example, here's a line from one translation of the Hippocratic Oath:
"I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous."
Yes, the pledger commits to avoiding harm, but there's nothing about making it a top priority. Meanwhile, Of the Epidemics says
"The physician must be able to tell the antecedents, know the present, and foretell the future — must mediate these things, and have two special objects in view with regard to disease, namely, to do good or to do no harm."
Again, there is no clear priority given to the avoidance of harm over the goal of providing help.