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Seems like the report was well received by the press.
I'm relieved and encouraged by what I've been able to digest so far.
Can't wait to dig into the ICER report more later on.
I'm trying to focus on what this means to Amarin's negotiations with Medicare, the Veterans Administration, third-party payers, etc. As far as I can tell, it seems pretty positive. The preliminary conclusion in the report was something to the effect of, at the current prices, the drug appears to be cost-effective, with some room to spare. That's a great report to bring to the negotiating table. I'd like to go back to gg's linked article a few days ago where I think the FDA was granting wider latitude to drug companies to communicate with payers ahead of FDA approval.
Would love to know what is being said between all of them now in anticipation of expanded label approval. And I wonder if we'll see an immediate impact on reimbursements.
Amazing response! From the VP of Communications no less! Just speculating, but if ICER is as tough and no nonsense as their reputation seems to be, and they are all about consumer protection and controlling costs and seeing themselves as a sort of guardian of the public trust, and still in the process of building their reputation, then I could see them having the attitude of a very strict professor. Like an A is for perfection, so no one gets an A, and very few A-minuses. Just a complete guess and nothing more on my part.
Very much appreciated, turby!
Thanks, study. I'll talk to my doctor and look into these testing companies. My goal is to eat fish four times a week, but I probably end up having it maybe three times a week at most. Fortunately my wife got me eating fish long before I discovered Amarin and this board.
I'm thrilled over the report today. Never been so excited over a B-plus. That was a big B-plus!
Same to you on your investments. Best wishes!
It's the first time, PSea.
The organization is relatively new. But its influence is apparently growing quickly.
The public has been wanting to try to control the price of drugs, etc., and ICER stepped in with these cost effectiveness evaluations.
Is the EPA/AA ratio something that automatically gets reported in blood test results? If not, how do you ask for it to be included?
Airbaa, hope you didn't sell too much, or if you did, I hope you jumped back in in a big way. There's too much money to be made!
I picked up some more long-term calls myself. When I saw the news, I thought to myself, rats, I missed the upswing. But the price never really took off after the news, or not as much as I thought it would.
Can't wait for the part of this ride where we are all flush and reminiscing about the terrible old days!
Thanks for the suggestion. Honestly, there aren't that many messages to sort through, but enough to make me wish I had known about my mailbox sooner. Technology is not a strength of mine!
Airbaa, this is a small approval-stage single-drug development company on a relative shoe-string budget and limited revenue. Speculation, binary events, paranoia, buyout fever, shorting, capital raises, and crazy unexplainable price movements maybe should be expected. I would't be surprised of much of the fall in price after this secondary offering and the one in the fall was caused by lowered expectations of a buyout. Anyway it's not a mature drug company. Maybe your expectations are too big or too early?
I'm guessing JT is in it for the long term, full speed ahead and short-term prices be damned. Until we make it to post-FDA approval it will be interesting and even afterwards, but hopefully less so.
JT has us in great position, at the threshold of a huge event, with full control over the company and over a drug with enormous potential, with cash on hand and the backing of influential investment banks if we need to get more or make deals. With no debt and no restrictions. With priority review from the FDA and the Canadian version of the FDA, and with support in the medical community including the ADA SOC guidelines, and with encouraging sales numbers.
Thanks, GG, for the timely boost of encouragement. All three posts were great to read.
Well, I just discovered I have a mailbox. I had no idea!
I noticed my mailbox and out of curiosity opened it up and realized I have messages I never read or replied to. I thought I had to scan the board for replies, which was very hit or miss. Sorry for ignoring people. Now I know.
Hoping for good news tomorrow.
Gus, just my own opinion, but I hope you will reconsider and keep on posting. Heck, you've been here since 2016! Obviously, this is your place as much as it is anyone else's. I did feel the need to chime in, but I didn't mean to be judgmental. My bad for coming off that way.
One of the reasons I love this board is because of all of the great back and forth discussions. People contribute their information and opinions. Other people agree or disagree or add or subtract or whatever. If we can't agree on something, we agree to disagree. Maybe it is asking too much, but generally speaking I don't think we should handle the issue of race any differently.
All the best.
Not saying there was anything intentional, but yeah, I could see some people being highly offended and hurt by your statement, Gus. Not meaning to judge anyone, but there it is.
"Responsible company would have taken debt and paid back with business rather than diluting shareholder values."
Clearly JT and management prefer dilution over debt. And that might be unsettling.
I don't think that taking on debt is such a great alternative. Money isn't free. A debt has to be paid back. Nobody buys a car or house without having to consider whether they can afford the monthly interest payments. Not anyone I know anyway. I get the sense JT wants to keep non-selling expenses as low as possible so that when the people that pay the money negotiate their prices, there will be money left over for Amarin to make a respectable profit. And given that no ultimate price has even been established yet, that makes the need to be conservative even more compelling.
Bet you anything that in JT's list of goals, getting Amarin and V across the finish line ranks above short-term shareholder satisfaction. When he's weighing the two, I think the latter loses out. So a secondary offer beats out taking on debt. One is comparatively cost-free for the company. That's okay by me if it's to accomplish the first goal, which I hope will benefit me and satisfy me more over the long run.
But you still make a fair point about dilution. Keep in mind this company has been in the drug testing and approval stage for forever. They haven't had enough revenue to do much more than keep the ship moving forward. I wouldn't even call it a ship. More like a raft. I guess it all depends on your point of view, but I see what they've done there alone as quite an impressive achievement. So if they want to do an expansion or capital investment, and their revenues aren't exactly overflowing, they have to get the money from somewhere else.
Bummer, right? But I'm hoping they won't have to keep diluting. If they get the FDA approval they need and some time for the world to adjust, I'm hoping their revenues begin to flow fast enough to provide for solid organic growth, without the need for more dilution. I expect suitors or partners will be willing to pay more, maybe even something satisfactory, if we get FDA approval, and maybe that will provide some cash as well. With FDA approval, I expect it would be a brand new day in many ways.
Hoping and praying!
Thanks for confirming that, Funny. Makes me feel just that much better about things.
Time will tell, maybe, who is right. Or better yet, hopefully it won't matter to anyone because the price will be back up high enough to satisfy us all. And stay there. For at least two weeks in a row.
Vertical integration might also allow them to expand and strengthen their research into production and process methods. Process patents can comprise an extremely effective intellectual property portfolio. I wouldn't be surprised if some of their existing patents are all about that. JT has said over and over that this drug is difficult to make. That creates a lot of opportunity as first in the field.
Agreed. The only thing that I feel fairly certain of out of all of this is that BP has not given Amarin an offer it finds acceptable.
JT is doing the right thing by doing everything he can do to go the distance if BP doesn't make an acceptable offer.
Well, no one can complain they weren't offered the same deal as the institutional investors. This is your chance!
Raf, I think very little chance of a buyout before the FDA decision. But afterwards, assuming FDA approval, I think the chances are better than even for a buyout within the first 18 months. In the very least, I would expect some dealing. I believe there are strong incentives on both sides after FDA approval.
I would be disappointed if they sold out for 2 x $18.00. I can't see Amarin agreeing to that. Amarin might as well take the ball and run with it at that price. They could easily surpass that on their own.
Trying to put this secondary offering in context.
JT raised the revenue forecast. Announced it to the world. "Amarin management anticipates higher sales revenues." What else can be interpreted from that? They aren't absolutely certain of higher sales, but they aren't anticipating lower sales. Just expecting higher sales and hoping for higher sales.
And in anticipation, they are hiring more sales reps. Perhaps there is also a need to create marketing materials including print and television ads, ramp up drug production, and have money for unanticipated needs.
And so, they want the money now, a little over two months before an anticipated FDA approval.
But of course money doesn't grow on trees, and JT is not a magician.
Hence the secondary offering.
Not saying this didn't hurt me. It hurt a lot. I hate this. I was expecting $23 a share about now. But somebody has to pay up if we want to take full advantage of what looks like a promising situation.
No doubt, I'm frustrated too. I wish this were a lot easier, like investing in Amazon. Just hoping and praying it pans out.
But in context, I think we still have a good thing going.
Thanks, Sam!!! Incredible news!!! : )
Anyone know if advisory committee involvement would make priority review less likely? Could that slow the process down enough to justify a standard review instead. Thanks.
Hey Funny. I understand that. But have you looked at these other patents?
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=0&p=1&f=S&l=50&Query=5840944%0D%0A&d=PTXT
Just in this one quick search there are 90 patents showing, many of them awarded to Amarin in recent years, presumably, maybe, with life beyond 2029. What is the value of these? I wish we could ask JT at the next meeting. Or could we ask the company now? I understand they may not have much value, but I am curious to know.
Thanks, JL.
I'd love to know the value is of Vascepa after generics come onto the market. I've been wondering also just what the agreements are that were made with the generics.
There is still so much about this drug that is a mystery.
Glad to hear that, JF. Pretty amazing!
Maybe some day I'll start taking V too, if they'll let people take it like vitamins.
For now, I've just been trying to eat fish more often, about three or four days a week. And I've cut way back on chicken, but not completely, ever since I started reading up on the EPA/AA issue.
Funny thing is that over the past six years, I have had a burning sensation and weakness in each of my forearms whenever I used them to lift moderately heavy objects or pressed down on surfaces with them, or played racquet sports. But just recently, about a three weeks ago, the burning and weakness went away completely. I believe it was either the fish, or just as likely, my vitamin D was really low, and I just recently began to take D3 supplements more regularly. Anyway, I thought the burning and weakness was simply a sign of getting older, and now I'm thrilled to have discovered that's not the case.
Quotes: "Does anyone have any idea if the manufacturing process is difficult enough that Amarin has been able to build a moat around it's product, in terms of cost effectiveness, stability, purity, etc?"
***
"... probably not."
***
Well that would be a disappointment.
JF, is the Vascepa helping with the pain? Another year or so and hopefully you'll be covered. Good to know you have a union health care plan.
Agree that priority review and the four months knocked off would be very good news.
I've heard JT say over and over again how hard it is to make Vascepa. I've heard many say on this board that Amarin will have a first mover advantage over the supply, maybe over the process.
Does anyone have any idea if the manufacturing process is difficult enough that Amarin has been able to build a moat around it's product, in terms of cost effectiveness, stability, purity, etc? In terms of building up its patent library, in the same smart phone companies did in the past? I wonder how much of a competitive advantage over generics and dietary supplements all of this will be when the original patents expire.
I know JL has mentioned some of this in the past, being able to be the most cost effective.
A lot still has to fall into place, obviously. And like others have said, no one is beyond criticism.
But it seems JT is as qualified as the next guy when it comes to managing biotech startups.
For anyone not already familiar with his background:
https://www.reuters.com/finance/stocks/company-officers/AMRN.A
I didn't realize this is the fourth startup he's helped to lead.
Just for kicks, here is a list of patents resulting from a quick patent search citing Flubbers patent. Many are Amarins. It was just a casual search, and there are probably a lot more related patents out there.
Just points out that I'm not sure anyone really knows what we have here in V. I'm sure Amarin didn't obtain these patents so that could mount the certificates on a wall. You'll need to cut and paste the below address:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=0&p=1&f=S&l=50&Query=5840944%0D%0A&d=PTXT
Kiwi, thanks for the article. I think it shows off JT's admirable ability to be both the visionary leader and the practical one-day-at-a-time operational CEO.
They go hand in hand in this case. To make Amarin attractive as a buy-out target and get as much money as it can, it does need to hit its drug development goals. But it also needs to prove that, if necessary, it can and will go it alone.
Mass,
To the extent they are sitting on their hands, i'm guessing it's because they need to reserve their resources until the time is right.
The time is not right yet because:
1. Currently, Amarin is extremely restricted in its marketing of off-label usage. All the company can do is have their sales reps personally contact physicians and other health care providers with pre-authorized information. No direct to consumer advertising is allowed. Absolutely none, in accordance with the agreement the company made with the FDA in their settlement of the company's lawsuit. And yet we've been told by some on this board that the impact of sales reps is limited due to less accessibility than in the old days and less influence generally. So it appears communication this way, by sales reps with no advertising support to back them up, is going to have limited effectiveness as a selling tool. What will change this is the hoped-for expanded label approval by the FDA. With that approval, Amarin can market the expanded on-label usage to its heart's content. It can blanket the country with advertising if it decides that is best.
2. It appears from recent discussions on this board that many insurers and other third-party providers are not covering V as much as we had hoped for. My understanding is that many of them are waiting for economic analyses to be done. Until that happens, it looks like adoption will be slow. But the good news is that those analyses are coming out this fall or early next year. Once those reports come out (with hopefully favorable numbers), then the payers and Amarin will be able to negotiate prices for the drugs, coverage by payers will be easier to justify, and individuals will find the drug much more affordable.
I think Amarin management has done an admirable job. The Reduce-it trial was huge. Who disagrees with that? The FDA settlement was huge. While it didn't give Amarin everything it wanted, the restricted sales efforts have been crucial to the company's ability to bring in much needed revenue. It gave the company enough life blood to continue as a going concern instead of being forced to sell itself cheaply to big pharma, or being forced to beg for relatively expensive financing from venture firms or other deep-pocketed investors. It has allowed Amarin to get by with a minimal secondary offering.
I believe Amarin is doing everything it needs to do to set itself up for later on down the road, this fall and into 2020. Part of that involves conserving their financial resources until they can get much more bang for their buck. My feeling is that, for now, without all of the pieces in place for explosive sales growth, they are doing just enough to keep revenues flowing and their operations on track. Anything more, such as hiring more sales reps, may very well be money spent unwisely and prematurely.
What I think some may be upset about is that things are not happening as fast as they had hoped. What's the hurry? Six to nine more months is not that long in the scheme of things. Clearly this has hurt those playing the options market, but everyone else will be okay in my opinion.
Thanks, Sam.
Hopefully the trend will remain positive overall. One would think ADA SOC, etc., should allow continued progress with prescriptions in the near term.
It feels like more and more what is really going to matter is everything after approval of the expanded label, including the script numbers. All is fine even with these numbers if you're holding long term in my opinion.
Great if you can, but no problem if you can't. Thanks either way.
Thanks, Sam. Hope all is well. Take care.
JL, knowing how long and how much you've believed in the drug and in the company, that's a powerful story.
"IMO indication Amarin is shooting for is primary prevention regardless of Trig level."
Makes sense to me. That was such a great video! Loved seeing their excitement over Vascepa.
Thanks for the excellent video, BB.
Very informative and encouraging remarks and overall tone.
Based on several statements by Dr. Bhatt, I wouldn't be surprised if Amarin is pushing for indications with triglyceride levels well below 150.
Steve and LBL, hoping you are right. I'd like to be more reassured since ICER analysis presents a double-edged sword. Could turn out to be great for Vascepa and play to its strengths, but I don't know.
How does Vascepa measure up based on cost effectiveness?
May speed up adoption by insurers and others, if ICER determines it to be cost effective, but even then, will there remain a challenge regarding lower profitability, or is cost to produce low enough that profitability is not a concern?
It doesn't seem Big Pharma controls this, at least not on the surface.
https://decisionresourcesgroup.com/drg-blog/will-institute-clinical-economic-review-evolve/