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and if we don't get Italy on board and make some progress over the pond, there really isn't much to sell to BP. To me, we are in crunch time.
I'm with you JRoon on the litigation timeline. Though, 2-3 years is quite more optimistic than my guess. As far as injunctive relief, I would seek clarification as to which court and jurisdiction this strategy would be pursued. Sounds like the ITC would have to get involved and I know by experience that they operate about as efficiently and predictably as the district and appellate courts. I have yet to witness any activity suggesting that Amarin seeks this course of action. This has never been a very aggressive legal campaign on our part.
The children shall inherit the earth. Gimmicks will set you free. Whether it is a reverse split, a buyback, or any other kind of action that takes one's attention away from the mundane and boring topics (regulatory approvals, operational efficiencies, reimbursement programs,......etc), continue to whine, place blame on others, look for the under-handed reasons why this investment hasn't worked out to the script written so eloquently in your head. Over used statement, but I have to say it, "if you can't stand the heat, get the hell out of this kitchen".
sharks in the water! something is happening
RMB- There really is no reason for the company to be listed on the nas. This investment is an asset play and we know where the value levers reside. Progress in the legal/commercial US market (authorized generic?), rest of world regulatory approvals with reimbursement programs, high level scientific promotion and education of the benefits of IPE are the biggies that will not be impacted by Nasdaq inclusion/exclusion.
That said, it will be a long road from now when Nasdaq delists a company that is providing an actual approved (in many countries) product at cash-flow positive operation. RS kills all shareholders. I believe Denner still remains top shareholder. It would be a cutting off his nose to spite his face sort of thing.
DAR and ram, thank you for your responses. I just had to share my recent experiences showing just how bad a side effect can be from a drug that was tolerated by me for over 15 years. While the ace inhibitors work wonders for most, the less than 1 % crew that I now belong to will never go near this class of drug again. Go with the ARB when possible. It works on a different pathway and does not inhibit the degradation of braykinin. What a mean little peptide it is.
DAR- switching from Lisinopril to an ARB may have been the biggest favor your doctor could do for you. Today is my 6 month anniversary from my first ER visit with potentially fatal Lisinopril induced angioedema. With severe tongue swelling, I came close to needing airway management to prevent waking up on the wrong side of the grass. A couple of ER visits later, I still have regular bouts of facial, upper airway, and groin swellings that have made my life a prison sentence. While the bouts have become less severe and should eventually pass, the only medical advise I get is to always be close to a facility that can provide emergency airway management. This is a Brady kinin mediated event that does not respond to antihistamines, steroids or epi. I have stopped the Lisinopril after the first event, but it can take months to over a year to be free of the symptoms.
RMB- I've stated many times that having lived through similar type IP litigation, time-tables need to be stretched past 5 years up to a decade for complete resolution on each case. Settlements typically happen during the meat of the trial on the courthouse steps (years away from today). Alex Denner did not invest over $100,000,000 to wait around and root for good legal outcomes. The generics are not acting very concerned - hell, Apotex just filed a complaint to the NJ court claiming that Amarin must be unfairly leaning on IPE suppliers as for some miraculous reason, the brand is able to hold on to over 50% of the total market several years after the product became generic.
I have not heard the cc, but if someone offered that a reverse split is even in the realm of possibilities, we are toast. Every short shop on the street is now putting a target on this ticker. I don't see a way here anymore.
RMB- I think delisting is not a terrible fate when you consider that this company will soon be in a battle to remain north of the $100m / year in total revenues. The business plan seems to be to keep the spend to an absolute minimum while time is bought for the progress of getting row onboard and set up for reimbursements. We do not need to be a listed nas. company to achieve our plan.
can we at least now all agree that a buyback has no place in the on-going actions of this company. Ramp ups in row, multi-front legal battles, rapidly declining domestic revenue, challenging supply chain obligations, etc. .....................
Chromosome, very possibly correct. I recall reading some recent comments coming out of Amarin Italia that sound like they are gearing up for an imminent launch. I'll try to hunt those comments down.
I believe the ST poster alluded to the delay as more of an overall issue relating to the Italian healthcare system and one not Vaskepa specific.
RT- thanks for the awesome trip idea. I have already started the research. I think walking 18 miles a day should counteract the weight gain from the great food.
biggest waves, best meds - I should retire there.
The anti-trust complaints underway in New Jersey that have been recently augmented with the newest generic addition (Apotex) describe how Amarin is unfairly advantaged in the IPE market by way of their exclusive (free market killing) supply contracts. I believe I even read in the newest complaint that the proof of such advantage is demonstrated in how the brand manufacturer has to date been able to keep the majority of the market, years after the first generics have shown up.
How much more rope is needed here in determining exactly what % of the market the generics currently believe they are entitled to?
Sounds like you found the "back of the napkin" plan B that Denner used to make his decision to invest over $100,000,000 into the Amarin journey. I guess he was confident the Euro guys would extend IP protection to firm up his hedge.
NS- I do agree that we got the right panel. As jaded as I have become, I still check the CAFC site multiple times a day. Keep hope alive!
NS- I have heard portions the proceedings and read direct legal accounts. There is no defense as to what is happening in the market and induced infringement is real and obvious. The generic manufacturers do not appear to be concerned. I can only surmise that for many reasons (the most prominent being the complex decision/action chain that occurs from when the doctor prescribes to how the medication is provided and paid for) these manufacturers feel the cover of the system.
I just don't think the necessary parties are encouraged enough to pierce the cover. Like I said, I've become too jaded.
I believe (through long tough experience) that investing in anything requiring policy change is simply a quick way to turn an investor into a poor social activist. I take the original CAFC rule 36 and the actions of Judge Andrews in Delaware as an accurate telltale of the appetite the courts and government have in addressing the shortcomings of the existing law.
An order remanding the case back to Delaware will in my opinion include the prescription to how the generics can continue "business as usual" without fear of further litigation. I may simply be that jaded, but I doubt it.
JRoon- I can't agree more with two of your points. This case will have no impact on the fate of Amarin (as it will not exist in current form in the 4-5 years that it will take to fully litigate this case), and the case itself is far from "super strong". Apotex proves the latter point in its filing yesterday. They state directly in their lawsuit that Amarin would lose nearly all of their market once generics entered the market. Not a care in the world about indication and any concern about staying in the skinny label lane.
NS, would we not be advantaged in the future if Amarin was able to offer either brand (requiring exclusive contracts) or generic (down and dirty price competition) to all of the US market? I can imagine that we would have some policy advantage to being the only supplier offering both brand and generic. If not, why was this ever even a consideration? This was first mentioned by John Thero shortly after the loss in the 9th district. I have always interpreted this card being suggested by various leadership over the years as a fall back to ensure that if necessary we can reduce margin to keep supply advantage while the ROW is further developed.
What about tiers and state mandates wrt generic vs brand. These were issues discussed on this forum for years as major advantages for generics in the market. They no longer mean anything?
JRoon, can't argue with that. We both hope Alex knows far more than we do. I believe that the prospect of the buyback was put out there during an opportune moment several months ago to jump start some action back into the stock. It did help to get the stock back into compliance. If I were a betting man, I would think that the buyback has been shelved for now and Denner will have the UK acceptance for buyback placed in his vest for future use.
I have always been of the belief that a company should buy back stock when it appears that doing so is the best investment alternative it has for excess cash on hand. How can such an argument be forwarded with the current state of the business. With the recent dramatic reduction in revenue that appears to be coming in the US market (our only significant market for now), with instability in leadership, with the very slow uptake of business outside the US, with several of the big euro countries offering no visibility wrt sponsoring Vaskepa, with challenges coming from the supply chain that will continue to plague the company as growth remains stagnant, etc,.etc.,.... Where does the excess cash come from? We just received a long extension on exclusivity in Europe. This is a long term investment. Not a quickie. Doing a "low rent" buyback now is a dreadful mismanagement of money.
they must not go forward with buying back shares. It is merely a financial gimmick to temporarily prop up the pps 10 or 20 percent for a very short period of time. Anybody who has been in a penny stock that runs out of money knows the outcome of the dilution that will follow with "death spiral" financing. Everything must go into lengthening the cash runway. Not shortening it!
could be today, could be a year from today. I've been involved in a litigation stock(RMBS) where the district judge took over a year to rule on one motion. The courts have no concern for time. Days to months, months to years, years to decades. The goal that each judge wants is settlement. Prolonging the process acts to accomplishing the goal. The CAFC also has little concern for time, although as busy as they are, will rule 36 as much as possible.
wow! 21% institutional holdings. I figured we were in the low 30's- looking rather moribund at the moment. Looks like Denner's original investment is more than all current institutional value.
how in the world can a buyback be justified under these conditions?
The complete lack of catalysts in the near term (6-18 months) puts the issue of buyback on back burner. No company with the circumstances faced by Amarin should be considering such a blatant misuse of capital. The buyback will most likely occur later as an effort to bring share price back up to compliance. They need 2-3 years of running time at current run rates to tread water. That is what I currently see.
I don't know where this "bankers running the business" notion came from, but the information I see shows the top 4 executives with a combined 90 years of pharma/bio experience. Also, I guess Denner himself has embellished his track record in the industries as well. What is his doctorate in? To call these guys merely bankers is a bit of a stretch.
CAFC April 2, 2024
I think the expected rotation from tech to bio/pharma is at best put on hold. Seeing the action in tech/growth really hits like a sledgehammer when one considers the huge opportunity cost incurred by hanging around this ticker for years. Hopefully some progress will be shared next week. Any hint of progress will have to do. Europe has been incredibly quiet for the last several quarters.
i don't think earnings is scheduled yet.
"Has anyone considered that maybe Amarin's prior management and current management have looked into those legal avenues, and deemed it not a viable option?"
Not to mention the engaging of top IP firms that live for this stuff. So funny how everyone here decides that Amarin had employed the keystone cops for the original appeal when our guy wasn't able to get past Dyk's Novo obsession. No lawyer had a chance in the appeal. I was warned years ago that when it came to matters of IP law, any lawyer not specifically trained and skilled in this subject was essentially a layman in theses matters. This advice came directly from the General Council of a tech company I was invested in that lived in the courts pursuing IP legal litigation.
I guess Dyk will get his 3rd bite of the apple here. Hopefully the other jurists take more than a minute to familiarize themselves with the briefs. As a betting man, the
money has got to be placed on rule 36. Call me a pessimist or maybe an optimist with way too much experience.
"Maybe I should start prescribing it to more of my patients." Is this collective malpractice by just about all the doctors in the U.S.?".....
Most insurances switch V for generic in the CVD indication. Imagine trying to get any coverage off label in AD. No insurance company will cover V for AD. Patients will not pay out of their pocket for even the fountain of youth. Docs will continue to advise the eating of more fish.
According to a poster on Stocktwits, 7 million shares have been traded off exchanges so far today. This guy reports dark pool trades almost everyday and seems legit. If he is in fact correct, a ton of volume has traded via DP over the past few weeks with little impact on price action. Big boys at play here?
Sleven- Thank you for the link. Looks like V is progressing in the Irish system in a normal way.
"A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of icosapent ethyl compared with the current standard of care."
Sounds like a punt. I wonder how long such an assessment takes and what new fun pops up after the HTA is tackled. Somehow I thought we were further down the road on this.