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.
Not sure 1 person is enough evidence to suggest the street has much doubts about approval. The recent analyst mentioning the label is the catalyst and not the approval, since the street is accepting approval, probably has access to more people than 1 random person from 1 random internet board.
The FDA approves almost everything that gets this far, near 90%, what would make Vascepa part of the 10% that gets rejected? Nothing. There is nothing at all to make it stand out in a negative way.
I've seen it on stocktwits recently so you can usually find it there on Friday early Am
Well, you have to assume market is also going to do a big December tank as well, the dilution did not account for most of that drop, the overall market sentiment did.
No sure that's completely accurate.
AMRN was 17.34 on October 10, right around same price now
IBB was 111.22 now at 104.74 or a 6% plus drop
In addition Amarin has suffered about a 20% dilution of shares overall since last September so stock is actually up 20% in market cap since
295 million shares in 10-Q for September 30 and 357 million shares now.
That's a huge amount of dilution, yes for some they got cash but also a good amount were just sold by management.
So you have the sector out of favor, ton of dilution,and a pretty good market cap for sales of $400 million in a year and no expanded label yet.
Amarin will be revving up sales, they should do $700 million next year no problem, I hope they can do 1 billion, that hopefully follows with 2-3 and then up to 5 billion in a few years. That seems like a very likely scenario. If that happens all shareholders will make money, so it is a low risk stock but market needs to see where revenue is going and how fast after approval. Remember the stock did jump big initially on better than expected revenue, THAT will be the main driver going forward.
50 Billion 75% GP is 37.5 million, add other costs and taxes cash flow is likely near $30 million. If they get 80% GP that's $40 Billion max, but over 10 years not including any other costs or taxes or profit on the $30 billion investment, again not unrealistic to say that they need $50 billion in sales to justify $ 30 billion
Also said there 20 years, not saying it's true or anything but all the info makes sense financially knowing how the BP would look at it
Yeah saw that after, was not factoring in all the other options
I can't find where they said that
"So, ICER inflated their numbers? They didn't mean to say that 1/2 Adult Americans should be on Vascepa? I could've sworn they said that."
They said 1/2 population is effected by CVD so Vascepa would have a large population eligible. Do you have the quote that says they said 1/2 the population would be eligible for Vascepa? We know you have to be on statins to get Vascepa in RI and this the label wills ate that so eligible is not half the population but just statin users.
Those numbers make sense though it's very hard to get good stats on statin users. How many people tried and stopped using due to side effects that will try Vascepa, for example. on flip side I know several people on statins solely due to Cholesterol numbers but whole family has high #'s and no heart disease ever in family but they get lower health insurance costs with lower #'s, get no side effect and it works so they would not go on Vascepa as they see no need.
The population that will actually take Vascepa starts with all statin users and goes down from there. 12 million low and 20 million high seem very reasonable population #'s.
Of course future studies may change that but any major changes are so far off I think we need to focus on what this expanded label gets us for population and stop with pie in the sky numbers.
Am I missing the half the population quote? ICER said half of adults will be effected by CVD and because of that fact a large population would be eligible for Vascepa. In this case eligible for Vascepa will require being on a statin so for the foreseeable future the populaton is a percent of statin users.
Amarin seems to have said very little about EVAPORATE, in the filing they say RESPECT-EPA results in second half 2021, when they talk about EVAPORATE they don't mention any end date in the filing despite it supposedly ending September. Have not read transcripts but was the end date mentioned at all on call today? Seems odd they have very little update on this trial.
Rumors get around so not impossible to hear a rumor, true or not, who knows.
Regardless, All the numbers line up with logic and line up with my own modeling. Even $30 billion make sense for Amarin to throw out there.
Unlikely BP would go above $20 billion, the modeling puts that at the peak price once generics suit resolved and expanded label happen. Amarin runs the same models.
This part is interesting
"They must get a buyer to see sales of 5 billion in 4 years."
About the same timing I have thought for 5 billion but I think that will happen without a buyer. If they can't get 5 billion in 4 years without a buyer management failed. I do see why she would say that, though. Just think she's not taking into account the uniqueness of the situation.
With drug prices on the political agenda, any changes there could hurt or harm Amarin, Vascepa is relatively low price but any large government policy to lower drug prices will likely lower price for Vascepa as well. But will also make Amarin attractive in a price control environment because it is a low price and high volume drug. This was listed in the recent filing as a risk to the stock and probably one of the more realistic risks but also a risk the makes a BO more likely if it was to happen. Though at a lower price.
That's how you get a buyout, you try to maximize the value currently by being aggressive.
There is no way to know if GIA or BO is going to happen until after FDA expanded label, and then maybe not until generic case is settled. Until then there will be no concrete offers, and without concrete offers you assume GIA as management.
They have been approached regularly for partnerships. Which means interest is high from other companies in their product. We will see what happens pretty early next year but this CC has nothing in it that would give anyone any idea how this will play out 6-12 months from now.
Shares outstanding based on today's filing:
As of July 29, 2019, we had 357,214,478 common shares outstanding
The consolidation and redesignation of the Series A Preference Shares currently outstanding would result in an additional 32,818,464 ordinary shares outstanding
So that gets us to 390,032,942 total shares outstanding once the preferred shares all convert. With about 12-15 million in a change of ownership for BO scenario you are at just over 400 million.
With incentives for management and employees with GIA success you are still going to be close to 400 million shares in a year with GIA.
You need to adjust the 23.90 down by the dilution to get an equivalent market cap. Still not 20.90 bit closer!
If they had 5 billion in peak sales and took a few years to get there the total life of drug sales before generics enter ends up around $45 billion. So that's a good answer as to why not $50 billion.
Remember there are approx. 35 million shares from both recent raises all around $18, that creates a nice support but also a huge amount of shares looking to exit at some profit level so it also caps the upside price a bit and also seems to indicate around $18 is fairly valued as of today.
-IF they can de-risk with label expansion AND get generic suits off table AND EVAPORATE study is positive then peak sales estimates will rise to the 5-10 billion recently mentioned by one analyst, remember most have 1-3 billion peak estimate of sales, assuming next years option grants and all shares get converted that possibly could in the future we would be nearing 425 million fully diluted shares and thus we have an all-in market cap of 7.6 billion or so. With the street looking for Blockbuster drug selling 1-3 billion seems reasonably priced.
-The market for Vasepa is not half the population but a percentage of people on statins, what % of that # that decide to take Vascepa will determine peak sales estimates, potential growth beyond that down the line would not effect price in the near term.
-It is a 1 drug company, patents and generic potential is a big overhang regardless of odds of it being a real issue. Amarin will settle when the companies except a reasonable payout and accept the same date as Teva, since court date is January nobody is in a hurry to settle until court date is close, just the nature of court cases in general.
Good points, hope it's true in terms of $30 price target, personally expecting it to settle around $25 but need to get some resolution on the Generics court date in January to even reach that. A positive surprise would be an expanded label that is less restrictive than street is guessing. I think street believes approval is going to happen, but there are some small doubts.
It's a big overhang but one most expect will go away. So by itself the catalyst is not as great as most would think but it will open up for more institutional investors and others to jump in that are waiting for AMRN to fully de-risk.
It also brings in the speculation of BO again.
It'll be interesting to see what happens with price post approval but people should temper stock price expectations a bit, it should solidly get it above $20 (FINALLY!) and if the generic suits get resolved I see $25, to get past that it all becomes about revenue growth if GIA so we will see how fast Amarin can raise sales.
In terms of your hedging, the fact anyone gave you crap about it is just a testament to the following and respect you got on this board, they just got scared that if you are hedging maybe there is an issue type of thing. It's just common sense for you to do it.
There are several people on the Facebook group posting they are all in on this stock, I get it but you should not go all in unless you are going to be OK if things go to the toilet because nothing is 100% guaranteed. I plan on going part-time and semi retire at 53 in a couple years, if Amarin goes to $3 I probably can still do that though adds more risk, if it goes to $30 plus makes that more comfortable. I could go ALL In and if it doubles I won't even need to be part time, but if it goes back to $3 I'm not retiring in any fashion anytime soon. Risk/Reward, smart to hedge even if risk is low that you need it.
Once FDA approves that goes away forever, people don’t read those details, they get an FDA approved drug that helps them be healthier, that’s all doctors and patients will know. Even ICER Mentioning that still was a very good grade, FDA will look at MO but just like everyone else they cannot conclude it had that much effect to account for the total results, so they approve, might be different if side effects were large but they are minimal.
I think we all have a button that the MO mention pushes but it is not going to matter at all and will never be spoken of again once approved.
This was reported when it happened and Amarin was not the responsible party, it does explain the need to have the 8-k but nothing to do with need to raise now and my understanding is it is not an Amarin controlled database so the vendor, not Amarin would need to contact anyone effected and would also be liable for anything.
You need to read the SEC filings. They had the same language in there for many quarters before the last raise as well.
I think they pretty much did
"As part of the normal sNDA submission process"
Normal the key word there. I don't think this is an issue, if it was it would need to be disclosed with offering.
And they need to money for the lawsuits from the people that just bought into the offering?
They had over $200 million in cash, why would a 3 month delay(which makes no sense since the gave PR) make us glad for a raise now, they could just raise after approval, they raise now because they are certain they need to advertise and hire and add more supply starting in September. If they, impossibly, get denied expanded label this money is meaningless. So assuming label is expanded, and a delay is a very small possibility, but a delay would mean you don't raise now IMO. Has no benefit without on-time expanded label.
He corrected that tweet with a follow up, to mention it was $17+ not 19.40, still questions timing but is not lower than last raise, is slightly higher.
And they got $400 million in cash on the books and no debt. Always amazes me how oversold these offerings get, good thing is in the next 6 months a bunch of positive catalyst coming and odds of negative news pretty low. With a news driven stock that's a good thing.
Yes there is a press release from Amarin
I think with the shares being offered they had to legally add these, just a formality and probably at the behest of legal council.
No signs point to any such thing, you don't offer new shares with large firms backing the offer to their clients while hiding bad news, it's not only unlikely, it is illegal.
If they only changed that so you have to close all short positions we'd be in business!
That is based on absolutely nothing. Amarin management has made several comments that make it clear they expect approval and on time. The company is not preparing itself for delay, if they expected a delay, they have 200 million dollars in the bank, they would not raise now, since we know they expect approval any delay would be unrelated to getting approved so why would they raise money and start hiring if they thought there was a delay coming? Anything is possible but management obviously believes no delay and approval, THAT is what the raise indicates.
Once they approve early or on time will be seeing the next group of posts on the generic court cases, then when that's resolved we will here about government intervention in drug prices....in the mean time the price will steadily head higher.
If they raise again in the future it's for rapid growth/acquisition reasons. Since they continually stated in filings they needed more capital if approved for expanded label we can at least be happy that it is behind us and won't kill the post approval momentum.
Except that all flies in the face of good old common sense
Not sure, it says "assumed" at that price, just might be for math purposes but will need to read the whole filing to determine the offering price, unless pre-bought nobody is paying more than market price for the shares.
I don't think cash raise has anything to do with whether a BO will happen after approval or not, they decided for a position of strength that they needed to have the money so they can grow it fast if BO price does not materialize.
If there was a BO pending it would be announced, otherwise you go full in on GIA until someone reached your price, guess what, if they raise $400 million and have $390 million left and get a BO offer the $390 million gets added to the price, it's cash on hand.
I take it unless Amarin Management totally screws up this should be the last raise unless some time in the future they are buying other companies.
Cash flow should be positive in the billions in a few years.
Expected by me all along, but expected after FDA approval, I would assume they think approval is in the bag(safe assumption)? Otherwise they don't need the money.
5% or so dilution and depending on final price will be the new "number they can't get over" for the stock price for awhile.
In addition the timing gives them strength in BO negotiations after approval also, pay now or we have plenty of ammo for GIA, not like whatever money is left is not paid for in a BO so has no effect on ST BO price.
$400 million seems like overkill unless they are using half that to invest in higher capacity and it does say that might be part of it
" (2) to increase commercial supply of Vascepa from third-party drug product suppliers"
Not shocked as totally expected a raise, a little surprised by the timing and size.
Stock will likely not recover above 20 until after approval, too bad there but is what it is.
Except Amarin would not have any info on what went on that meeting before they did their release. Could there have been an FDA leak about the meeting, yes and it would coincide with the Amarin press release coincidentally. Amarin would need to start hiring based on the September date anyways so they can be ready to hire and train as soon as approval word is given.
The PDUFA date is set as Saturday because of the timeline for days just happened to be on Saturday, they would not make a decision and send a letter on the Saturday, they would do it on the Friday at the latest, and do they ever have an ADCOM and PDUFA outcome on the same day or even 1 day apart?
Exactly right, common practice with hedge funds
I'm thinking September myself...pfffffft to 2023! It looks like it may settle around 22 for the new consolidation but always possible goes as low as 20 depending on overall market, I think we consolidated nicely from 17-20 and hovered around 18 for awhile, now I think we will settle at a new higher price for a bit, until more news or unless market tanks.
I think mid-19's is way too low, expect it will stay above 20 and hopefully above 21 as it bounces 21-23 for a bit......and then next wave higher.
Yes and no since the study is small it would need a larger follow up study to confirm the results and benefits. So then it would come down to how great are the results, will it be so great there is a lot of off label use?
I would imagine good results would have the medical community with a need to confirm results in a larger study as per the study design:
"The overarching goal of this trial is to assess whether icosapent ethyl beneficially affects intermediate physiological measures associated with onset of AD in order to evaluate whether larger, multi-site, longer-duration Alzheimer's prevention trials are warranted to assess more definitive clinical outcomes."
So really iffy if this study would lead to floodgates being open unless results were ridiculous overwhelming (unlikely in any trial but always possible), it is more likely that it would take several more years after to confirm positive results in a larger study.
Just when tasty says not a whiff of generosity or civility on the board!
Great positive post, we are lucky to have these types of resources in doing DD on stocks, anyone can take advantage of knowledge we could never gather on our own, it is a wonderful thing when used that way.
Good luck in retirement, congrats on the speedy recovery.
The article from this week linked to an older article mentioning up to 10 billion but that was a random joe, no analyst has come close to those peak sales, I don't see how on July 2 all of a sudden everyone just buy's into 10 billion peak sale. Also no analyst is going to upgrade peak sales before FDA approval and some more info on sales ramp up after that.
Maybe word of the Black Out period finally got out HAHA
Does seem that way, maybe FDA early approval, FDA did have interim meeting scheduled, maybe leaking out of there approval was coming and coming early? Just total speculation on my part but seems to me you need approval before any BO materializes. Other option could be related to court cases settling.
Volume and price action do not equate to what was in the press release, Monday will be interesting with many traders returning from vacation, if uptrend continues strong with volume then definitely something more going on behind the scenes.