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Wow, those look great. Thank you for posting.
Agreed. The patent case looks very solid to me. Just pointing out that Amarin does have 100% of Europe until they partner it, and it's a continent with 500 million people. Yes they would pay less and yes it's an expensive undertaking, etc etc etc, but Amarin is not broke, far from it, already is in Europe and the sales over $400Mil are going to reach $700Mil even in a disaster situation.
The company is undervalued even when I calculate out the absolute worse outcome.
sts66, You've made a clear and convincing case for what would happen should Amarin lost the patent case which I also must say is highly unlikely.
There is however 1 MAJOR flaw in your prediction around Europe.
I'm of the opinion that if a catastrophe were to occur and Amarin lost and the Generics took over the US market, Amarin would NOT, partner Europe.
The PPS may indeed go thru the turmoil you suggest, but the end result would not be quite so dramatic.
1. Sales of Vascepa in the US are still going to hit $700+ million this year as it would take time for the generics to ramp up. Amarin would eliminate advertising, and sales staff, and support and be pretty profitable while sitting on over half a billion in cash.
2. They redirect those resources to going alone in Europe and run the operations from Ireland where they are already established.
They could still realize Peak Sales of $2 or $3 billion per year by 2024 or 2025 from global operations including being a generic competitor in the US.
Would any of that be fun? Heck no!!! But there would be a reasonable pathway for the company and this is partly why I scratch my head at the current market cap. Way too cheap even with catastrophe taken into consideration.
JL I for one totally agree with your assessment. They might call themselves very stable geniuses, but that does not make it so.
I think we all agree we just don't want the Judge or anyone falling for something as dumb as them saying their JPM2020 presentation was "perfect" and no inducement, no infringement, a witch hunt, and fake news.
Yep and I'll bet the generic patent lawyers say they only have the best people or we don't know the people who gave that presentation at JPM2020, I mean, maybe we have our picture with them, but we have our picture with everybody, thousands of pictures with people we don't know, but the presentation was still "perfect" no inducement, no infringement, witch hunt, fake news!
I hope you're right Kev. My fear is the Judge could be dumb enough to listen to the generic lawyers saying the JPM2020 presentation was a "perfect" presentation, and this pointing out the facts on our actual slide show is a witch hunt, and a hoax. Everyone knows it's a hoax, the presentation was perfect, no inducement, in infringe, all a hoax, fake news.
TTE you are spot on. That is exactly how the law works. Showing intent is not about a word for word confession like saying I'm holding military aid from XYZ country until you fabricate something I want. It's deciphering the more subtle like seeing the request of a "favor" in exchange.
It's the same as a guy running a grocery in Chicago in the 1920s who has the actual police turning a blind eye to his shop being robbed who is told, we could probably get to that and wouldn't it be nice if the police ya, know had a place to come in and have "snacks" whenever we were hungry? Hard to do on a policeman's salary.
Pets and treats for you.... Good boy.
TTE you are like a dog so used to being hit that when the owner raises his hand to give you bacon you immediately crouch for the blow.
The Judge has already given multiple clues on infringement.
The Generics DO NOT have a 20% shot at winning.
Not even close to that. Maybe 2%...
The odds are so dismal they should be throwing themselves at Amarin now begging for a settlement before losing 100% of what's going to be a gigantic market for 9 months to a strong and capable generic producer in Teva.
TTE your read makes sense but a “puncher’s chance” correctly implies the generics have lost the match on the judge’s score card if we are using boxing terminology correctly and now go into the final round with only a lucky knockout punch that can save them.
Now the pressure on the generics must be mounting by the hour to find a way out of the mess they’ve made for themselves. The probable outcome of them having to watch Teva monopolize the market for 9 months before they can enter is much less theoretical.
Boxing allows the corner to throw in a towel to stop the fight. I would suspect the generics must weigh very carefully the probable outcomes. I suspect they would now accept a settlement on Amarin’s terms but I’m thinking Amarin may be content to just beat them outright and hold the title belt over their head while standing over the generics limp beaten body.
Raf, great find... Nissen must have been grabbed by aliens and replaced only in body with a new brain. Or AZN has a real interest.
HDG you have been great providing insight on our legal path. What is your opinion of today’s activity in adding pressure on generics to settle?
The international and for that matter the domestic revenue targets/estimates are all too low. That being said I think there are 2 prevailing views that I also share.
1. Everyone recognizes the blockbuster potential and simply want to get the IP issue resolved. That should NOT be taken to think the IP is in any real danger, it’s not, but we need the generics to either go ahead and settle or to watch the embarrassment they will incur at trial. Once this is done expect the stock to move to new highs.
2. While JT and the management have proven to be outstanding in getting us this far they appear too small to the task of actually running the company in the sales execution and global ramp phase we are now entering and the need to broker an M&A deal is at the forefront now.
I read today’s coverage as positive despite the Neutral on the $22 pt. She’s telling clients Vascepa is on track to be a blockbuster “and then some” and openly admits M&A could provide a huge move up. She’s simply allowing the IP to settle before she upgrades and even so provides a pt higher from Friday’s close.
I think it’s very strong and I think upon generic settlement which is likely soon upgrades galore pour in.
No. The defendants have something to lose too. If they press thru the trial and lose they suffer the following.
1. Likely to be ordered to pay Amarin millions in court costs.
2. They will be forced to wait 9 months longer than Teva, who did settle, to enter the US market. Presumably the market will be mature and worth between $2 and $10 billion dollars annually. Teva would have the opportunity to convert much of that to their generic before Defendants could get their first script. Also assuming automatic refills this is a potential for Defendants to miss out on massive $$$.
This game of chicken will only go on for a bit longer. IMO there is close to zero chance the Defendants will roll the dice considering they will lose the trail.
Thank you BB
BB, the 12 week argument dies in the language stating as an add on to maximum tolerated statin. Statins are lifelong drugs. Period. End of story.
As an adjunct to statins. Statins are a lifelong drug. There is no ambiguity.
I stand by my point. Dr Reddy’s total sales for the 6 months Teva would have in front of them would be ZERO. That is not debatable. In the course of 6 months half of the entire refill market would be placed on Teva’s generic. There is simply no arguing this point.
On the patents I think everyone should just take a breath.
I'm NOT a patent lawyer, so consider that with what I'm about to say.
The generics are pinning all their hopes for a win on 1 thing not 2. Yes, they have two points, but let's examine the first one.
"There is a select market for lowering TG levels in 12 weeks that stands alone and would not infringe upon Amarin's patents."
This argument is absurd. There is no chance of winning on this as there is overwhelming evidence that managing TG levels is a chronic issue and doctors would simply write refills into infinity. There is IMO zero chance any court would allow that and I don't think we need to lose any sleep over it.
Now the one issue the generics are hoping for is to get the court to agree Amarin's patents should be invalidated as they were issued in error, the error being "obviousness."
In this instance the generics are asking the court to go back in time to change their view with the today's understanding of how EPA works and apply it to the thinking of the issuance of the patents in the past.
This is beyond simply unlikely as well. I doubt the court would be convinced to do so.
At the end of the day, the generic claims and litigation are an attempt to shake down or extort Amarin for payment and while the court must follow the law, I believe the court has signaled thru the Summary Judgements and notes from the judge that they view it as such and are not happy about it viewing the entire thing as bordering unethical use of the courts.
Amarin now holds all but the final card of moving thru the proceeding. A settlement is likely IMO but for very little money and entry to coincide with TEVA. If the generics do not settle? They also stand to lose possibly a billion dollars over time. Consider that.
Dr Reddy goes to trial and loses and gets nothing.
They can not enter the US Market until 2030 6 months behind TEVA.
How many scripts will TEVA fill in 6 months that Dr Reddy will never get once they are on automatic refill with TEVA? It will depend on how big the US market is in 2029 but that in more than theory would cost Dr Reddy hundreds of millions of dollars in perpetuity. It would cost them billions over time as they fight to gain market share from a forever crippled position having given up the market of 6 months at the start.
DO NOT THINK FOR A MINUTE THEY HAVE NOTHING TO LOSE!!! THEY DO!!!
The GS report/note was really well written and bullish.
In my opinion it telegraphs the intentions. It covers Mineral Oil, the history with FDA, their internal physician surveys and it all points to a strong likelihood of a successful Adcom and eventual approval.
Everyone gets hung up on their current pt. Forget that noise.
IMO, GS is basically saying "hey clients, just be aware it's getting approved and we are not trying to influence the price today, but upgrades will be coming so plan accordingly."
That can be a signal to shorts or those looking to establish a position long.
GS does have a loyalty to the big clients who buy $$$ their advice.
Meh,,, Adcom coming and time will take care of the PPS. It's going much higher and the minute by minute, day by day is just noise.
Meh,,, Adcom coming and time will take care of the PPS. It's going much higher and the minute by minute, day by day is just noise.
Amarin has zero control of who a BP might choose to represent them in making an offer, and GS owes AMRN nothing.
JT wanted a successful secondary and agreed to the terms and GS executed it for their fees. End of story from AMRN's perspective.
The GS report is actually really good from a regulatory perspective and on issues like Mineral Oil. Where it falls short is in the revenue projections... Way short... And there may well be reasons that cloud GS from wanting to put a big number on it. My hunch is they are signaling to their short clients it's time to change direction and the revenue and pt were a gift to help them.
Time will tell.
BB,
As folks are sending info about Vascepa to Bernie, anyone with contacts should also send info to Larry Kudlow as well. He suffered a mild Heart Attack in the last year too.
This place has gotten out of hand. The conspiracy theories and angst and worry over FDA and MRC are not in context of reality.
Is there anyone happy about the Adcom and the delay? No. But this is not 2013.
Vascepa is a marvelous medication with an incredible track record of safety and efficacy in treating very high Triglycerides. There is simply years and years of data on that fact.
The last Adcom vote fell short with FDA basically saying run a CVOT and come back. Amarin did. And Reduce IT gave them what they needed in spades.
The Adcom will take place with Amarin having ICER, NEJM, ADA, AHA, NLA and many of the finest Cardiologists in the country on their side.
The only prominent dissent I can find quoted is Dr Nissen, who is running a competing study for AZN and even he concedes he believed the Reduce It study was positive even discounting any possible influence of Mineral Oil.
I can't acknowledge MRC's views as they are anonymous, clearly motivated by money alone, and not peer reviewed by anyone willing to step from the shadows and attach their name and credentials to it.
Believe me, if anyone associated with a nationally recognized medical organization or group of cardiologists were willing to throw dirt on Vascepa Matthew Herper at Stat would gleefully provide the platform, not because he hates Vascepa, but because he hates small mom and pop investors and his job ultimately is to drive controversy to drive readership and subscriptions to Stat news and yet, he can find nobody other than those working on the Vascepa competitor willing.
Everyone should just relax.
We are holding all the cards.
BB,
FDA "WILL" approve the expanded label before or on the PDUFA date but in a limited way.
The expansion will be limited to TG above 150, and nothing for Diabetes, family history, or history of past Ischemic events.
The Adcom, "WILL" be held to discuss whether the label should expand further and will be built around the reality that TG are a marker/indicator but are TG the only thing physicians should be using to determine who should be on Vascepa?
Post Adcom the FDA will expand the label further to TG of 135, and a host of other qualifiers.
This is my prediction.
I'm here. Yes quietly working. No change in my AMRN views. Working on another couple of names.
Thanks JL,
I'll also say I think FDA is 100% correct to hold the Adcom because nobody can answer one question.
How does Vascepa work?
Imagine FDA 20 years from now it it were to be determined taking Vascepa for 20 years causes you to grow fins?
I think they love the safety profile. I think they love the Reduce It results. I think they look a Jelis as conformation Mineral Oil is meaningless.
But still they can't answer that basic question. So for cover they will get the panel to vote on has Vascepa shown to be effective delivering benefit with a very safe profile?
They will get the YES and have the cover they need and we will be off to the races.
Sorry JL I did not... Hard to keep up with all the posts today. Which post are you referring?
Hey North,
That's the point. Once everyone get's their legs back under them from the "surprise" reality will begin to come into focus.
Vascepa is one of the most researched, tested, and safest advancements in Cardiovascular health in a generation.
My bet is the main issue unresolved is MOA and does it matter?
Does lowering TG prevent ischemic events? Is TG the cause? The answer is no. Loveza lowers TG but does not reduce ischemic events. So then how did Vascepa do it?
IMO they want to argue, analyze and debate around this subject. There will be hypothesis around inflammation and TG as a "marker". They will go back and forth but in the end given 2 things Vascepa's label gets expanded.
1. Vascepa's safety profile is incredible. This elevates many concerns.
2. Reduce IT is a CVOT not a search for the MOA. The trial getting a 25% RRR, is statistically inline with the earlier Jelis study with no Placebo getting a 19% RRR.
Bottom line, it's safe and 100% it delivers benefit at a substantial rate and patients and care givers need greater access to it.
I'm sorry can some long timers please respond?
I was not here in 2013, and I'm seeing anxiety about the Adcom and how AMRN was "ambushed" by this particular panel with FDA's help. Can I ask a few simple questions for clarity?
1. At the last Adcom were we represented by Dr Bhatt?
2. At the last Adcom had we completed a 5 year 8000 patient CVOT done hand in hand with FDA?
3. At the last Adcom had the materials been peer reviewed by NEJM?
4. At the last Adcom had Vascepa been reviewed by ICER?
5. At the last Adcom had Vascepa been named standard of care by the American Diabetes Association?
6. At the last Adcom did you have the same number of patients safely using Vascepa without SAE's as you do now?
Of course I'm being a bit sarcastic here but I'm trying to make a point.
So many long timers got stung they seem now to not see the difference.
Spot on... That's 100% correct!!!
Waters are calming. As expected. Again, we end today down between 4 and 10%.
Adcom is NORMAL in such a Huge decision. This is not a CRL. Free money IMO.
And for all the moaning about JT raising the money?
For the folks here who cried over it all I can say is NEVER play poker with JT. He's a master. PERIOD.
We are very lucky to have him running this thing.
My bet is we end today down somewhere between 4 and 10%. That's it...
Once it digests and the jumping off buildings ends, people will see, this is not a conspiracy, or MRC or Nissen, or FDA revenge. It's not a CRL, or clinical hold or suspension of Vascepa sales in any way.
It's the biggest approval FDA has seen in decades. 1/3 of all US Adults!!
FDA needed to CYA themselves. That's all this is.
Bus, if they wanted to take us down they would have cited something in the data and issued a CRL. An Adcom for the biggest drug since Lipitor is not unreasonable.
Sorry to sound off but folks need to get a grip.
Very good post and I believe spot on.
OMG!!! Did everyone see the CRL? How about the emergency halt of all Vascepa sales? How about the hold on the Evaporate trial to protect patients? No? Nobody saw that?
RELAX!!!
Everyone needs to take a breath,,,.
Amarin is on the edge of getting approval for a therapy that will impact 1/2 of all adults in America. People on this board talk about it all the time, but obviously tonight fail to grasp how big a deal this is.
FDA is obviously shaking in their dance shoes because this will be so big. They may have listened to the CP filed or from AZN or who knows who, but it would not have really taken too much IMO to get them to slow down and be sure every single base is covered on something this large.
This is not a CRL. This is not some sort of hold.
The company and Dr Bhatt will crush this. It's going to be fine.
JL, You are way off base. Not on science or medicine. Not on Vascepa and the benefits it will bring, but on the diatribe however cloaked in the interest of small shareholders against JT and management in general.
Management would have been fools to have not raised that capital.
You nor I can predict the future. I wake this morning to find another White Nationalist terror attack and Iran seizing another oil tanker.
There are protests in Moscow, and Hong Kong and a new leader in the UK willing to break off from Europe with no economic deal in place.
These types of things "could" at any moment cause a global calamity.
There is no assurance of anything. Ever.
This does not even touch the odds of us receiving a CRL. I put them at 1/1000...
A big part of a CEO's job is to ask "what if".
What if the FDA asks for a 2 year trial on another placebo? What if that happens while simultaneously one of any of the events above spins out of control?
JT has appropriately insured us against these and many other things I could sit and list, while simultaneously lining us up to go big at launch. That's the fact. I hate the PPS too. I hate Goldman Sachs and the folks getting the deal too.
But I can quote Buffett as well. On the financial crisis he compared it to being in a boat with the guy you think caused a hole and your taking on water. Do you kick him out of the boat or help him start bailing? If you let your emotion lead,,, you sink.
Best
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