Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Our lawyers did. We have the same counsel as GSK.
LOL. They are scrambling.
Have not seek his comment yet, but he completely did not know about GSK v. Teva. It's ironic because in his comment he said it would take some sort of case or Congress to change the law.
He didn't see GSK v. Teva coming.
The law is very clear in this case. The REDUCE-IT patents are still in tact and valid. Hikma nor any other generic can infringe on those.
What this new suit does it brings it to light / out in the open. Hikma has a decision to make now. Continue to put out generic Vascepa in an amount that exceeds the Marine Indication or stay confined to the small Marine Indication part of the sandbox. The pharmacy cannot dispense what it does not have.
Again it goes back to Hikma. Do you anticipate other generics now saying you know what we want to jump in here because stealing the REDUCE-IT indication is going to be easy pickings. Quite the contrary. Teva already learned a lesson. Hikma is going to find itself alone and with each passing day the more they infringe the more they will be potentially liable for lost profit damages. If there are only 2 players in a market, it's not hard to see which one is likely infringing.
Check mate.
The larger point is that it's brilliant because the lawsuit creates a downward spiral for Hikma.
The more aggressive Hikma is with producing generic Vascepa....the likelier they are to infringe on the Reduce-IT indication. The more infringement....the easier the path to show liability / damages.
This will not end well. Hikma can decide it's fate. The more aggressive....the more damages.
Filing the lawsuit was a great move. It likely puts other generics at bay and you're right it backs Hikma into a corner. Do you knowingly put more product into the market greater than the Marine indication when it's likely that you will be the only generic now trying to compete with Amarin in the USA. Other generics can see this has escalated beyond a headache given lost profit damages.
Then there's the lack of CV limitation in the Indication and Usages section of the labeling that is glaring.
For the generics this is no longer low hanging fruit but rather the potential for real harm to their underlying business if they are liable. You can find out a lot in discovery. Hikma's actions post the GSK v. Teva ruling to try to take down press releases and alter its website are telling.
Hikma may have thought other generics would be joining them at the buffet...come to find out it's just them and Amarin and there ain't much food to be had for the cost of admission.
Great move on Amarin's part. What's your move Hikma......
Check mate. I encourage everyone to read the complaint. You can find it on FAQs on Amarin's website.
The GSK v. Teva case served as a roadmap for Amarin on how to "catch" Hikma in the act and Hikma's own actions from its press releases to altering its website post the GSK v. Teva decision underscore this point. Even though GSK v. Teva is not mentioned, we have the same counsel as GSK (Singer) and you can tell Hikma fell right into the trap via their own actions post that ruling. And Amarin even cited to Hikma's expert about alternative uses of Vascepa aside from the severe HTG indication. Genius.
Not to mention the Indications & Usage section of Hikma's generic label did not contain a limitation for CV usage.
"Like the current VASCEPA® label, Hikma’s Label does not include the CV Limitation of Use."
Asking for a permanent injunction was great because it boxes Hikma in to just the MARINE indication, which is really all they are entitled too based on Judge Du's decision.
Check Mate. Hikma's hands were in the cookie jar and they were caught with the cookie (press releases, website changes, and no CV limitation).
Wow. Very interesting. Thanks for your quick response.
Pharmacydude if you had to guess a percentage. What chance of success (%) you think that Vascepa works on Covid?
Got it thanks. Yep, people want their sweetened / processed foods and would rather take a pill to keep eating the stuff they like.
Thanks again.
Thanks for sharing. Given 3 vaccines have shown initial efficacy, will this lessen the need for Vascepa even if it shows efficacy? How do you see this playing out given Pfizer, Moderna, and AstraZeneca vaccine are already there at finish line.
AMRN is not going to be sold for $15 lol. I don't know what price but a BO will be north of $15.
We have a Chinese partner. Again you don't need the entire 1 billion population. In a country where there's a billion getting only 10 or 20 mm may not seem like a lot but it's monumental because the starting base is so large.
Just do the simple math and you will see the royalty revenue is quite staggering.
The REDUCE-IT label will be a game changer.
I think it's very much realistic and it's something the market has not picked up on. Terrapharma tweeted about this last week. Check his twitter.
Just google China and cardiovascular disease. Tons of articles. It's high priority as our western diet has created a lot of heart disease in China.
The best thing is we are working with a local partner in Eddingpharm. They will know how to get the REDUCE-IT label. Their interests are aligned with ours. They want to make money too.
Just the sheer amount of people who live there and as JL always said this is a volume play. Well you have the largest population of people combined with Vascepa's potential.....numbers are staggering.
CVD is a high priority in China.
I think China could be worth quite a lot.
The press release said:
There were approximately 180.4 million hypertriglyceridemia (HTG) patients in China in 2019, representing approximately 20.2% of the adult population. Among all HTG patients in China, there were approximately 9 million adults who had very high TG levels (≥500 mg/dL). In 2019, there were approximately 36.1 million statin-treated adult patients in China with elevated TG levels (≥150 mg/dL) and either established CVD or diabetes mellitus and two or more additional risk factors for CVD, the addressable patients of the FDA-approved indication for reducing CV events of VASCEPA in China.
A previous press release said a royalty in the high teens. Let's say 15% to be conservative. And if it's 18% or 19% royalty even better.
Let's say 20mm people are on Vascepa in China times 15% royalty times price of Vascepa in China and you are looking at staggering numbers. Remember this is a volume play and fortunately Vascepa is not a high priced drug.
Even if it's only 10 mm people you are still looking at staggering numbers.
China is quite valuable and remember we are working with a local partner. Best way to do business over there. Cardiovascular disease is a high priority in China.
JMO
You could just do a CVR for those other indications. By waiting you start to lose value on USA whatever can be salvaged and Europe as clock starts with approval and then you have to negotiate reimbursement. It cuts both ways....you learn more by waiting but also give up on what you currently have not to mention a BP would want to steer the ship in Europe. BP could have a certain strategy on how it wants to rollout/attack Europe...etc
Interesting. The danger with waiting till 2022 is you lose another year of enhancing USA sales by not being in hands of a BP and also that means AMRN would be driving the ship on negotiations of reimbursement in European countries...
Wouldn't a BP want to control / decide that from the outset?
Waiting till 2022 is not ideal.
I agree.
JT mentioned M&A. Read the tea leaves. Who would hire a new IR person if the company is going to be sold.
A BP would want to steer the ship in Europe from the start me thinks.
Yes thank God we will have regulatory exclusivity.
I guess this puts further onus on hurrying up and getting approval in Europe before this goes into effect but we should be fine based on our regulatory exclusivity. Moreover, hard to see this being applied ex post facto to those drugs already approved but could impact new drugs if and when passed.
The flip side is that it could be a bonus to those who have drugs with a long exclusivity period like ours. Making those drugs with long tails more valuable if newer drugs seeking approval in Europe get curtailed with a shorter patent window.
In short, we could benefit from such policies because we have a drug with a long exclusivity period while other patented drugs are facing a shorter window. This could help our valuation to a BP.
If approval in China is "weeks" away with expanded label for REDUCE-IT, that will be huge.
Saw a figure where 1 in 5 adults in China have CVD.
We have a partner in China in Eddingpharm and that's the right way to do business there. Just collect the high royalties....the sheer numbers of people there can make this lucrative.
Expanded label in China plus approval in Europe -- the stock price will get moving soon and we will become very attractive to a BP.
We can let the BP deal with Hikma through its relationship with the FDA. A BP will have more leverage than we will. And let's not forget GSK v. Teva, which can give a BP more certainty around the USA market.
Maybe should have held off on posting scripts till after the market closed today to let the stock absorb this China news lol
oh well.
I suggest everyone listen to the Jefferies interview with JT this morning. Link can be found on Amarin's website.
JT pretty much said he's open to M&A.
Michael Yee did a great job of summarizing the situation for investors.
A must listen.
Can you say M&A? ......wow JT just did
Michael Yee is helping us with his questions.
JT very little energy.
Can he be a little enthusiastic.
Bio you are assuming Hikma is rational. They seem to be pretty adamant about going ahead with their launch thus far.
Bio. Thanks can you explain the link to Medicare Fraud piece of this?
Another thing to keep in mind this is reporting as of Sept. 30th for institutions pre GSK v. Teva verdict, which was Friday Oct. 2nd.
Yep.They sold 2.4 mm but it's great they still hold 32 mm here so they are steering the ship so to speak.
I'm sure they have JT's attention.
Even if it's allowed it seems like this could be a layup for someone with marketing expertise to design an ad campaign touting ours over theirs.
I think the company can certainly hire an investment bank but doubt they would ever publicly disclose that until any such deal is announced.
Is this what you are referring to under Secrecy
Secrecy
6. Are there any rules on maintaining secrecy until the bid is made?
It is a fundamental aspect of the Takeover Rules that absolute secrecy must be maintained until a bid is announced; this applies to both hostile and recommended bids. The Takeover Rules are very restrictive in terms of the extension of the "circle of knowledge" and Panel engagement is typically required earlier in the process than in, for example, the UK. If, following an approach to the target, there is rumour or speculation or an anomalous movement in the price of the target's shares, the bidder or target may be required by the Panel to issue a holding announcement that an offer is being considered or that talks are in progress. Unlike the UK, the Panel has not issued guidance on what constitutes an anomalous share price movement.
https://content.next.westlaw.com/5-502-0825?__lrTS=20201016193312322&transitionType=Default&contextData=(sc.Default)&firstPage=true
I think Teva got its extension around the 16th.
I imagine the deadline for the court to respond to Amarin's en banc filing has not passed. Thus, we have not heard. I don't know when the deadline is but I am not counting on us getting an en banc hearing.
Teva asked for and got an extension. Pretty routine.
Courts move at a slow place. These delays only help Amarin.
Now can Amarin execute to take advantage of this....
Teva has asked for an en banc hearing just like Amarin did. Teva has until Dec. 2nd to submit its filing for en banc. Will thet get it? Who knows. My point is that the longer GSK v. Teva gets dragged out the better for Amarin. Delays are our friend.
Now can Amarin execute and take advantage of such delay and an open USA market is another question. It's barely been a month since the GSK v. Teva ruling came out that shook up the entire generic / big pharma landscape. While this seems like an eternity to us that decision only came out Friday Oct. 2nd after being heard back in 2019.
The GSK v. Teva decision does not hurt us; rather it helps us. Thank Judge Newman.
Now can Amarin execute?
Whatever action they take by the 20th it will look nothing like the action they were going to take pre GSK v. Teva ruling.
Delays favor Amarin.
Can Amarin execute and take advantage of such delay is a separate question.
No sitting CEO of a generic company is taking this risk given the damages. Not happening. That's not their business. You can't try to game-plan away from a lawsuit because as we all know courts can be uncertain. We have a precedential case: GSK v. Teva. Judge Newman came through in the final hour for us.
GSK v. Teva shifted the risk calculus in a major way.
GSK v. Teva saved the USA market. LOL
shifted the risk back to generics.
While it would be great to get an en banc hearing, we don't really need it so long as the GSK v. Teva case remains in litigation.
Newman came through for us in a major way. That case could be stuck in the courts for a few more years with en banc plus possible appeal to Supreme Court. Generics are not making a huge investment nor trying to procure supply with GSK v. Teva hanging in the balance. They too have fallen victim to the courts. It happens.
Of course if Teva does not get an en banc hearing, then it's really game over for generics. Either way they are sidelined right now because of the damages and what they could add up to.
Perhaps Amarin and generics will now settle.....only time will tell.
That's on JT and management to make the case to Wall Street. They have been relatively silent since GSK v. Teva ruling came out.
JT needs to connect the dots for investors.
Of course Teva is going to ask for an en banc hearing. So this could stretch out well into 2021 and this does not factor in a likely appeal to the Supreme Court.
What does this all mean? What generics thought they won has been completely halted so long as the GSK v. Teva case is still pending in the courts. Why?
DAMAGES. There's not a CEO out there who is taking material steps until the case is fully resolved. The longer the better for Amarin. Delays in the Teva case are to Amarin's advantage because it keeps generics at bay.
Why is Amarin so silent on this? I don't know.