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DAR...I agree...The news that a BB was in the offing was crucial...mainly, in that it gave notice to investors that Amarin was financially stable...Now Amarin is expecting a catalyst to give investors and potential buyers additional confidence for a BO at a higher valuation than the present one.
The problem is that there too many potential culprits in cases where generics use off label prescriptions to infringe.
This makes it difficult for an innovating company to pursue a generic company for infringement on their patented indication
The parties to blame may include:
-the generic company
-the Doc
-the patient
-the pharmacy
- the pharmacy benefit plan
-the insurance company
-the government
A generic company may invest very little cash, and even though their infringing product may be inferior to the branded product... they can still stand to make lucrative profits.
Marzan...Information on China approval of Vascepa for CVD, as well as announcement of the Chinese national health service prices for Vascepa, are the 6 billion dollar questions...I would assume they will happen sometime in the first half of 2024....or, at the latest, in H2/24.
CBB....A drug such as Vascepa, that's destined to treat a large part of the world's population...must have a price tag low enough to be affordable to a large part of the world's population.
CBB...China approval of Vascepa for CVD opens many doors including...
-huge increase in volume of sales
-lower prices for API charged by suppliers to Amarin for the high volume Vascepa...than the higher supplier prices for API charged to the generic companies for the low volume generic knock offs.
-lower prices to national health services for Amarin's Vascepa
-an AG by Amarin for Vascepa in the U.S.
-blockbuster status for Vascepa in world markets (i.e. similar to that Lipitor)
-blockbuster profits for Amarin
MA5...IMO such important news is best delivered with a link, for a better understanding of the full details....i.e....if the Brave study did not show statistical significance, was there any positive trend that demonstrated that Vascepa ameliorated Alzheimers...or delayed the onset of Alzheimer's symptoms... as shown by the cognitive testing results or by the biomarker results in the study.
If so, the safety of Vascepa, combined with the severity of Alzheimers disease, might lead to the approval of Vascepa as treatment of AZ...perhaps contingent on the initiation of a larger study.
Posts with useful information, as well as posts with thoughtful opinions are helpful to us investors ...Posts with intentionally misleading information or with very extreme opinions, either positive are negative are not helpful.
IMO, PD and NS gave us important information...and even though I didn't always agree with PD and NS, I appreciated their posts....and I wish they would resume their posts.
Considering that Vascepa, which is 97% PURE EPA, is being perpetually mistaken for 'just another Omega 3'...and considering that the sales of Omega 3 drugs are expected to grow markedly in the future...perhaps it would now make sense for Amarin to rebrand Vascepa as Omega EPA...or Omega EPA-PURE to take advantage of this growth in the market.
Capt...Early detection and treatment are key to reducing Alzheimers,...NOT the removal the amyloid ...once it has already been developed due to inflammation in the brain...If the Brave study shows a positive trend towards anti-inflammatory Vascepa slowing amyloid development in the brain, it would be an important treatment milestone.
Jas...Some patients, sadly, will die after being denied Vascepa ...and have to take a generic as a poor substitute...when these patients might have had their lives extended...if they had taken Vascepa, as prescribed by their Docs, but substituted for with generics by insurance companies or pharmacies...Lawsuits from the families of the deceased might attract the attention of the FDA...especially if studies by Amarin or by a BP could affirm the differences that we know exist.
This also applies to the situations when pharmacists advise omega 3's or Lovaza, as a cheaper version of Vascepa, but... as a "heart healthy drug, which is just as successful as Vascepa in reducing CVD".
IMO, Amarin has better odds of being sold to a BP during the next 180 consecutive business days(i.e. about 7 months from now)..than it has of being under a buck at that time....When a company's stock is under a buck, BP's refrain from buying that company...because, if the BP pays a fair price for it, this generates criticism from the BP's own shareholders....
The goal of Denner is to get the price up high enough to generate a reasonable offer from a BP.
For those interested in TA...I noted this morning that Fidelity, which had pegged the resistance line for Amarin stock price (as seen on my trading screen) at $1.16 the during the past week), has now changed this line to $1.31..If Amarin price can go over that, it can indeed go much higher....especially with the gradual realization that safe Vascepa is really effective at reducing CVD.
CVD is widespread in every country...I suggest a simple slogan to be imprinted on the label of every bottle of Vascepa...IT WORKS!
Vascepa's largest competition, by far, is worthless Omega 3 OTC's...Its time for effective Vascepa to make inroads on this market.
Every food store and pharmacy currently has large displays of Omega3's...Wouldn't it be helpful for patients to see similar large displays of Vascepa, when they walk into a store or a pharmacy.
Bidmark...Why not go all the way...Have Amarin market a more expensive product, "Vascepa OTC" containing the patented capsule...and a less expensive product, "icosapentethyl generic OTC", containing the less expensive capsule...
Allow informed consumers...and national health care systems to make the choice.
Denisk...GS, increasing their position in Amarin by over 160 thousand shares, while having a sell rating...seems to me, admittedly a non lawyer, to be an illegal conflict of interest.
Capt...It is of interest to note that Lipitor in the UK has 73% of the statin market, even though there are statin competitors which are effective....all the while Vascepa's INEFFECTIVE competitors, containing both EPA AND DHA, have 76% of the Omega 3 market in the UK... even while Vascepa, which is EFFECTIVE, has only 24% of the Omega 3 market.
WHAT IS PFIZER DOING RIGHT?
This PR is reiteration of things we already knew...including..." PLANS TO LAUNCH AN AUTHORIZED GENERIC IF REQUIRED".
IMO this was the most important point of the PR...especially if China opens its market to Vascepa for CVD.
The increase in volume would make sense for an AG in the U.S. to compete with other generics on price.
IMO this PR is a heads up for what is coming.
kiwi....Nasdaq delisting rules..."Failure of a company to meet a minimum closing bid price of at least $1 for 30 consecutive
trading days can trigger delisting. When this happens Nasdaq issues a deficiency notice to the
company. Another action that brings a deficiency notice is a company's failure to file periodic
reports by dates specified by the Securities and Exchange Commission.
Receipt of Deficiency Notice Receipt of Deficiency Notice
Any Nasdaq company receiving a deficiency notice has four business days to file an 8-K form
with the SEC or to issue a press release to announce the notice. However, reporting failures
require a company-issued press release. The company must provide the deficiency notice’s
receipt date, unmet listing requirements, and action plan. The company must send a copy to
Nasdaq before issuing the press release.
Return to Compliance Return to Compliance
After receiving a deficiency notice, a company has 180 calendar days to return to compliance. A
company warned about its shares' minimum bid price must achieve a closing price of $1 or
more for 10 CONSECUTIVE TRADING DAYS DURING THIS PERIOD. Report-filing offenders must file the
required reports, and then must file subsequent reports by the due dates.
Additional Grace Period Additional Grace Period
If a company with a minimum market value of $1 million in shares held by non-affiliates
satisfies the other listing requirements, it may receive a second "cure period" of 180 calendar
days. To receive this, the company must notify Nasdaq of its intent to correct the deficiency.
Nasdaq may exercise its discretion in determining whether it believes the company can cure the
deficiency.
Delisting Letter Delisting Letter
If a company fails to comply with the minimum requirements during the first grace period or any
second grace period, Nasdaq will issue a delisting letter to the company. As with the deficiency
notice, the company must notify the investing public of the delisting letter within four business
days, by filing an 8-K with the SEC. The company then can appeal its delisting to the hearings
panel.
Hearing Process Hearing Process
KIWI...QUOTE..."Once a company receives a Nasdaq delisting letter, it has seven days to formally request a
hearing. This request effectively halts the delisting process until the panel renders a decision.
At the hearing, the company must present a detailed plan to regain and maintain listing
compliance. The panel may consider the company’s financial strength, general market overview
and historical pricing.
Delisting and Appeals Delisting and Appeals
After the seven days, Nasdaq delists a company. First it suspends trading of its security, then it
finalizes the delisting. If a company appeals but the panel rules in favor of delisting, Nasdaq
gives the company 15 more days to further appeal to Nasdaq or in federal court, but it begins
final delisting procedure"
The ten days for Amarin are over next Tuesday...After that, the process starts again.
Invest...Reverse splits are poison...That is the common wisdom...shared by everyone...probably Denner included.
FFS...my non TA take...Investors with large quantities of Amarin stock were unwilling to see the price stay below $1.00 for too long, which would have lead to a delisting...so they bought more cheap shares.
They will hold till further good news comes out, buying more shares if necessary...and, at that time, these large stake holders will press for a sale to whichever BP makes the best offer....
The upside is much better than the downside for Amarin.
island...Agreed...It all depends on your definition of "big acquisition"...For Pfizer, after buying Seagen for $43 billion, buying Amarin, a small company, already on the market, with a safe and effective drug, with which a fuse has already been lit by a current positive cash flow... would seem akin to devouring a minnow for desert.
Interesting after hours at 5:30 PM...Buyers on the bid for 130,000 shares at $1.09 or $1.10.... with only 100 shares on the asked for under $1.19
Someone wants to buy on the cheap.
Dusty...This PR from Amarin may shed some lite on the near term future for The near term trejectury for Amarin stock price..
"On January 9, 2024, Amarin entered into a conditional share REPURCHASE agreement with Cantor Fitzgerald & Co. (“Cantor”) to purchase up to $50 million of Amarin’s ordinary shares held in the form of American depository shares (ADSs). The implementation of the share repurchase program will require Amarin shareholder approval as well as UK High Court approval, as required under UK company law. The Company intends to call its 2024 annual general meeting of shareholders early in the second quarter of 2024 to seek shareholder approval of the program, which would be followed by the UK High court process. Amarin anticipates that these steps could be completed by the end of the second quarter of 2024, with share repurchases commencing shortly thereafter."
Assuming that Cantor does not already own these Amarin shares, Cantor will need to buy them in order to sell them to Amarin, as per their repurchase agreement...This should keep the price up, at least until the repurchase agreement is fulfilled...
By that time, catalysts from the US, Europe and ROW, including China, should have begun to check in.
Interesting article on Amarin's future...However, probably in the interest of brevity, the author did not mention...potential new EPA products which, are catalysts for Amarin, such as EPAMAX(patent applied for) which is a new formulation of EPA, allowing it to be better carried in the lymphatic system(and better cross the blood- brain barrier) for the treatment of ...
-cardiopulmonary,,cardiovascular, and cerebrovascular diseases(including Alzheimers)
-cancers(including lymphoma)
-huge potential in China
My first MI was in 2010...At that time, A coronary stent was placed and I was started on 80 mgs/day of Lipitor along with antihypertensive drugs and blood thinners....In the following years I had 2 strokes and 2 MI's resulting in the placement of 3 more stents. My last stroke was approx. 10 years ago while I was on this regime. The stroke(which, in retrospect, might have prevented if I were taking Vascepa)...resulted in my retiring from an active ophthalmology practice...
I continued with my previous therapeutic regime after my last CVD and my cardiologist at the Mass General Hospital added Vascepa 4 gms/day during the last 8 years...After my INITIAL Rx for LIPITOR in 2020, my LDL fell from over 200 mgs/dcl and has remained at under 100mgs/dcl ever since....I have not had a CVD event since taking Vascepa.
I was surprised and disappointed when the FDA set a minimum level of 150 mgms/dcl LDL or more...plus either established CVD or 2 additional risk factors for CVD,as criteria for approving patient Rx for Vascepa for the CVD indication....I believe that millions of patients with LDL under 100mgs./dcl could also be spared CVD events
At the time of the FDA approval, the FDA still had concerns about side effects from Vascepa...The fact that millions of patients used Vascepa since its FDA approval...with placebo like side effects have assuaged these fears.
IMHO it is time for the FDA to consider adjusting downwards the criteria for prescribing Vascepa.
In an era when drugs for CVD and especially for cancer, which have many side effects... are costing tens of thousands and even hundreds of thousands of dollars per patient, Vascepa, which has been proven to be a very safe and effective drug, saving people's lives and dollars for medical care and hospitalizations, seems relatively cheap, even before an AG.
KIWI....China approval of Vascepa for the CVD indication, plus an AG in the U.S....leading to a lower prices for the drug, both to self paying patients and to government health plans, may make Vascepa even more appealing, not only to Germany, but to the ROW.
As John Thero was wont to say "Vascepa is a volume play...not a price play".
LBL...IMO Germany denial of Vascepa was about price rather than efficacy...When Amarin drops its price, Germany will drop its denial.
CBB...AGREED...Each time I walk into a Costco store, I shake my head in disbelief at large displays of "hearthelpful" OTC omega 3's....Where is the U.S. FDA in this costly scam?
Capt....This study was done using omega 3's(containing DHA as well as EPA), and the drugs may be confused with Vascepa(97%pure EPA) by some detractors of Vascepa...To avoid confusion, and to save lives as well as cash, Lovaza should be removed from the market...as it has been in Europe.
ggwpg...Thanks for the transcript of the JPM conference....
My guesses after Holt's talk:
-China approval of the CVD indication for Vascepa in the near term is a real possibility
-cheaper prices for Vascepa, together with increased volume of sales, will follow China approval for CVD
-lower costs for API, sold to Amarin, will follow the increased volume
-an AG for the U.S. will follow
Holt projects that Amarin cost cutting will result in $40 million in savings this year...These savings will come close to paying for the 50 million shares Amarin will be buying back in the first quarter.
The Q4 2023 report makes clear that Amarin has $300 million plus in cash and a positive cash flow...It also indicates that Amarin has an accepted product(Vascepa) in a vibrant market in the US and in ROW...with significant potential to become a blockbuster drug.
Amarin's positive cash flow is very important.....it enables Amarin to handle any unforseen events and to take advantage of opportunities to expand their business.
EPS follow positive cash flow...and eventually lead to dividend pay outs.
Amarin
Financials are looking good...
"Revenues: For the fourth quarter, Amarin estimates total revenue between $72 to $74 million (Europe ~$1.5 million; U.S. $64 - $65 million; RoW $7 - $8 million – including supply shipments and milestone achievement) and between $304 to $306 million for the full year 2023.
Cash Position: Amarin ended 2023 with approximately $321 million in cash and investments, with positive cash flow of approximately $10 million for the full year. The Company has now reported six consecutive quarters of cash positive or neutral operations."
Amarin is subject to UK law...not Irish law
"On January 9, 2024, Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald & Co. (“Cantor”) to purchase up to $50 million of Amarin’s ordinary shares held in the form of American depository shares (ADSs). The implementation of the share repurchase program will require Amarin shareholder approval as well as UK High Court approval, AS REQUIRED UNDER UK COMPANY LAW. The Company intends to call its 2024 annual general meeting of shareholders early in the second quarter of 2024 to seek shareholder approval of the program, which would be followed by the UK High court process. Amarin anticipates that these steps could be completed by the end of the second quarter of 2024, with share repurchases commencing shortly thereafter."
Volume over 2 million now..Some one is accumulating...My bet is on Denner.
QUOTE..." The preliminary results suggest that the trial may not have meet its primary endpoint, which was an improvement in blood flow in the brain"
Obviously the Brave trial did not meet statistical significance, but it still may have trended positively...With the small number of patients in the study, no one really expected statistical significance anyway.
If the Brave study results are positive(or even if they are negative), it will attract a tsunami of attention(as well as critique)...This may be why the researchers want to be very careful before releasing these results in a respected organ.