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It’s really 99.99 to .01, you basically know the outcome based on the briefing documents. Just waiting for something to come out on the trial that’s a surprise but so far is pretty much useless trial as they really could have just use the briefing documents and been done with this.
Or a really interesting, not by the book, strategy.
Did she say all 800 reps or all reps, my understanding is they have not hired up to the 800 yet.
Lipitor was priced similarly to Vascepa and did 13 billion in sales. His point is that peak revenue should be high even though the drug is being priced affordably/cheap relative to trying the price gouging approach.
It's basically been his standard answer for awhile in terms of why they don;t just double the price with approval and it being a volume deal not a pricing deal.
Holding off....why? It's not going to have more value in a few months?
End of March for trial verdict. So now we have a time frame assuming no summary judgement from the bench.
It takes like 2+ years to get to trial, not really a concern at this point
Why? She said Amarin met initial burden of proof, dismissed their request.
Remember the ADCOM and all the angst and then 16-0. This is a court case, one side will present a one sided argument and so will the other and they have lots of hours to do so. Does not change the fact the generics legal position is weak. Nothing yesterday overcomes the initial opinion from the judge That chronic disease requires chronic treatment.
They need to resolve last overhang in this generic suit and then continually beat sales estimates every quarter. That’s how they’ll get the SP to rise in GIA. Though I feel they have a strong position in court a little disappointed it got to court when the vast majority don’t. Should not be an overhang at this point. I get the need to win in court at some point but that point, to me, is not after all the recent success and years and years of waiting. Perhaps generics just would not settle and no choice but missed opportunity here, it would take years for another suit to work its way through and with multiple settlements odds of going to trial in future would have been small.
Just seems With Amarin everything is the hard way.
It says CURRENT market not estimated revenue, which is inline with Amarin sales growth in that market from 2019 to 2020. It really is meaningless IMO
Other CEO’s have said that before and then Too good to pass up opportunity comes up and they do it anyways. It does mean if a BO is close, they probably lost out to someone else.
Of course it is legal, the market size is not a sales projection but potential market size. It’s generics that’s how they present a pipeline. Not a big deal here. We all know they plan on making generic Vascepa if they get through court with a win, that’s all they are saying,
It’s a nothing burger. Amarin has sales projections based on no generics until 2029, billions of dollars per year down the road they say. Should the judge hold that against them? The generics are planning on making Vascepa, that’s why Amarin is suing them. So they are projecting sales like Amarin, no different, if you read Amarin filings the risks are there including generics suit, same would be for Hikma.
That's the long term GIA dream, but you need to replace a BB drug by 2029, and BB which don't grow on trees, with multiple drugs that meet or exceed that or another BB drug. Not as easy as Amazon going from selling books to other items.
FYI if you’re on Stocktwits TheWysekid went for about an hour post lunch to the trial and has a brief summary of what went on while he was there
Isn't July 5 before dilution so your not comparing market caps, I think you need to drop that price by $1.10 for market cap comparison, still valid point that we area at a lower market cap but it was 18.72 a week before the 23.91 and 2 weeks later was in the 18's.
Yes, normal, they were part of prep work so they take them off at this point.
They have an outside chance but even if they beat the odds they are also 6-7 years minimum away from competing in best case scenario, so rather irrelevant. ACST was also, and science said they never had a chance but failing at this point is a bit surprising as they set a low bar.
Epanova failed as we all expected but removes a street overhang.
Amazing the overhangs the street puts on Amarin-ADCOM, FDA Approval, EPANOVA-all things on this board were easily dismissed as extremely low risk by common sense and good science. Next we have generic suit, already dismissed here by commons sense and great analysis but not on street. It pays to do a ton of due diligence. Though despite all the above the stock has not really gone anywhere since RI results but still, feels good to be smarter than the street!
I think you are coming from a perspective the generic suit is a big risk. It's a big overhang but I see it as a minor risk. No way IMO they raised money due to risk of generic suit.
They misread the uptick in scripts a bit, they did not do a good job of determining launch cost and timing (because of surprise Adcom and delay) so they thought they needed to cover expansion for 3 extra months and then they wanted a buffer for:
1) Negotiating from position of financial strength in BO
2) Not having to worry how much launch costs since so well funded
3)Money to pay generics in a settlement if it came to that
4)Street viewed them as low on cash, JT clearly made De-Risking huge priority which means they had to raise cash to de-risk
5) Bankers advised them they could raise more money than any other previous raise, I think they would have raised 2 billion dollars at 18 if there was a market, more money is more options down the line.
If generics actually wins the court case and Amarin feels they cannot win an appeal they immediately sell the company to highest bidder, at that point there is zero reason to GIA if generics are in the market in a couple years so raising money would be pointless. BP can pay 5-7 billion and recoup a lot of that in the next few years, BP could lock up supply at a cost generics will have trouble competing with to maximize the revenue, and then become the leading OTC supplier which could generate 500 million in current indication to 1 billion or more annually if other indications show success down the line.
IN terms of what worries you
1) SP dropping since label-the fear someone know something I believe does not apply, I think AMRN short is what many are doing and the herd is following, not uncommon in Biotech's and Amarin volume makes it more attractive.
2) Short interest is not that high as percent of float, there are many other BO's where the short interest was much higher, people have posted them here and other boards, also stock action similar after FDA approval in tocks that were then BO. Lots of short in number, yes, but not out of the ordinary for this type of stock. Most companies don't get bought out, shorts don't generally weigh that risk very high.
3) Generics will lose this case, I can't see a win by them, nobody has any argument that stands up where they win
4) Seems patents have not been weak, Teva settled quickly, they have filed a ton of patents, more than most companies their size, some will be weak but some are clearly strong
5) One statement like that out of context is not winning a court case but your other point is valid which leads to my list of things to worry about
1) I get the science, I get the potential in other indications but having the best drug in the world does not guarantee the company is the best investment. Amarin themselves are doing zero trials themselves, there are zero possible additional label usages in the next 3-4 years for sure and then who knows. They have the one partnership study with a different version of EPA, who knows how that will play out.
2) Street will continually discount sales as they rise because of the generics 2029 date. If they are doing $5 billion in 2026 and growing other companies would have a huge PE but Amarin will be very low due to the short window to generics. SO what is the real upside knowing you can't get a 20 P/E on your earnings, probably ever?
3)Some other drug comes and surprises with similar/better results-I see this as low but way higher than the generic suit risk. Science does not support this happening, the long time from statin to another drug that works(Vascepa) suggests it won't happen before 2029 but still over 9-10 years that is a risk.
That's basically it for me on GIA risk.
I'm still invested because outside of #3 shocking me the stock will be higher 2+ years from now despite the issues 1 and 2 cause. Just a question of how much higher and whether the upside with those main risks is big enough to stay here and not invest the money elsewhere.
I THINK they could sell for $40 today and also think it's 50/50 whether GIA ever results in a stock price above $40. Thus I believe BO is the way to go but also see where GIA is not ridiculous option.
This is the one decision management needs to get right.
Not buying that at all. If they were delayed they would be cash flow positive in 2020 earlier than if they were not delayed, they were already for 2 quarters in 2019 and would be 3 quarters if not for the FDA approval and launch prep, they would not have the big increase in spending for the launch so that argument makes no sense.
I know why they raised money, they followed the business school rule book and that's what it says to do. They did it to have money for the launch, simple as that. They made it bigger because they wanted to be 100% sure they had all the money they needed for any scenario and would not have to raise again.
Unfortunately, IMO, their analyses was flawed in terms of how much they needed to raise. Since management and the board gets basically free shares and cashes million regularly they were not that hurt by the over-dilution but also explains the lack of analysis on what was actually needed vs what they could actually raise. They decided to maximize a raise instead of shooting for lesser shares at a higher #.
Again, overall management has done well, they had guts to wait out the long years for RI instead of cashing out and selling at a low figure. Once that decision was made, however, they pretty much followed the business school 101 rule book. Look at the Steve Jobs, Elan Musks of the world that return huge shareholder value, they create the business books. Those people are rare and of course wish we had a visionary, outside the box, world beater CEO, but most companies don't.
All things considered, to date, they've been a successful team but if they ignore the obvious, by the book, next step of BO and they are going the more unconventional and risky route then we will see if they really are capable of going off script for bigger returns.
I'd say personally I'm pretty happy with the management team, they've gotten a drug approved with a wide indication. They managed to dilute to get the funds to get to finish line but end with little debt.
However, they are not foolproof and believe they have some things to answer for(which they likely won't)
1) Why a 26 million share raise for $460 million, did not make sense at the time, did not make sense even after ADCOM announced and based on recent 2020 outlook they won't touch a dime of that money in 2020. Maybe 1/2 that amount made sense, have a buffer for some unexpected and take money raise off the pressure of the stock but they have not justified the size of the raise and the additional dilution.
2) The board set option grants at a level that pays management a lot of shares that dilute the stock and also cause selling in the market. I would have preferred more cash payouts and less stock, they clearly have the money to have done that. They always had an out of selling the EU rights to get cash without any dilution.
3) What is going on with Europe, the elusiveness to answer questions on this is disconcerting. Why did it take so long after FDA submit to submit to EU? They said they might partner before FDA approval, might do it after but they were told by investors to wait so they did, so what's the scoop now? If they partner this year and get the cash up front, would be another misstep back to the last dilution becoming completely unnecessary.
4) They mention for awhile willing to settle these suits but trial is next week, if they don't accomplish settling I think is something that can be questioned regardless of outcome. Not knowing where generic stand hard to criticize now but almost ALL of these settle before court and they could only settle 1 out of 3 and left this overhang.
5) I understand they get paid in stock for a lot of compensation so selling what they get at times makes sense but they have not backed the stock with many market purchases, and the appearance that would gives that goes a long way if they would do that sometimes.
Again, stock had 2 good years from Jan-Dec returns and should have another by year end so despite the volatility management is returning shareholder value the last 2 years.
But I believe the above items are areas management should be held accountable and justify the actions.
Great new slogan once coverage expands
Vascepa...cheaper than a gym membership.
I'm talking about The July secondary which killed the stock momentum THAT time.
Since label was expanded in December its hard to get better coverage by Jan 1 2020. There are updates during the year and priority should be, and I'm sure is, on getting better insurance tiers. Unfortunately timing of the approval being delayed for ADCOM put them a bit behind in regard to 2020 formulas.
Since that delay 2021 has been the year to point to for any real massive growth. At that point fully trained sales staff, full advertising blitz 6 months leading up to 2021, better insurance coverage 2021 etc...
2020 will be challenging from a profit perspective.
I do wonder the need for the raise being so large if they plan on 650 million low end sales and 800 million high end expenses, they are negative cash flow 150, in worst case scenario which we know it won't be.
That still leaves them with 450 million, they raised 460 million. Did we need that much dilution, it could have been half as big. Pointless in a BO as the cash gets factored into sale price but for GIA seems dilution could have been 10-15 million shares less dilution.
It's the same on the same list from July 1, 2019 on the website so it has not changed on that list. There are so many lists it's unclear what changed and what effect it has in the grand scheme of things.
But that could be settled and a BO happen simultaneously so basically a BO could happen any minute so the point is rather pointless.
Also BP will know risks, just because this one settles does not mean the next one won't be along in a few months so not doing a BO due to generics means no BO would ever happen in the field of biotech.
BP has bought many companies at billions of dollars that came with 50% chance of never having an approved drug but you think they'll balk at less than 1% chance of a generic suit in this case? Seems unlikely, all analysis from experts I have seen/heard/talked to find the generics will lose case, I have not found any credible analysis that gives generics any chance. MRC says generics will win which is the best indicator they have no shot LOL. BP would want control of the launch they are not going to want to wait until maybe April for a verdict, if a BO was to happen they'd find a settlement generics and Amarin could live with.
The big issue Amarin has GIA is inability to ramp up sales fast enough and keeping costs down as they ramp, they have to spend way more than BP would to increase sales. So Vascepa is more profitable to BP than Amarin as a stand alone. For example BO would have a profit on Vascepa sales in 2020, Amarin projects they will break even, maybe.
So street needs to see them prove it. This will take all of 2020 to do, a year is a long time, a lot can happen, AKA more risk, thus the stock has temporarily peaked.
In 2 years with successful GIA we are higher for sure but company needs to do 1 billion in 2020 if we want to see $25-30 by end of THIS year. We may get to see if they are up for the task if no BO but street is basing price action on managements own guidance. If they solidly guided 1 billion with that increase in SG&A we'd be back near 25.
Maybe JT has got the under promise and over deliver even in regards to advertising?
It seems with the delay of a few months for Adcom Amarin would be 100% ready to go as fast as possible, seems no evidence that 6 months is the proper time frame so not sure why that take so long, I'm sure there is an explanation but just have not found it.
Obviously if there is a BO the generics get paid off and overpaid right away, if it costs $200 million to make them settle they'd just do it for a deal north of $17 billion. Pretty sure there is a price they'd take that Amarin and a BO partner would easily be willing to pay.
In addition, as everyone has noted, they could be in court for years with appeals and other generic suits. If that was a major concern than BO would be off the table.
HLS Halted pending news
https://iiroc.mediaroom.com/2020-01-06-IIROC-Trading-Halt-HLS
He sells every year same time, right after options exercised, expect to see a few others, surprised so far just him
It's half of the $42 BO price
Even worse considering they have as sure a victory as you can at this point.
Accept it's a slam dunk, so there's that.
Good to see the week over week New RX have such a big jump.
Basically yes but since we don't know what a settlement amount would suffice for the generics it's impossible to know for sure if it can be settled BECAUSE there is a BO. If there is confidence, based on settlement talks previously that, for example, $50 million settles the suits on no better terms than Teva then a multi billion dollar deal will not be held up and they would agree to settle before closing a deal.
Other than that it depends on due diligence, if they know it is going to trial it is less likely a deal is getting done but still could with CVR included related to outcome of trial or confidence in DD phase that it is not a major concern.
He had to give a forecast, yes he could have waited until January but with the approval made sense to get the sandbagged number out with good news as the # was not going to change. I think he should have had 750 as the upper number but analyst average 685 with low of 600 and high of 785 so you know he wasn't going near the 785.
This is the proper way to set low expectations, they just need to raise guidance a little with each quarterly report and stock will go higher.
ACST halted for news pending
Maybe, depends on the deal and who is the EU partner, if its someone that may buy the company down the line and they pay a good premium then it would help stock price. If they get similar deal with royalties they would have huge cash hoard to launch US. There is something to it hurting BO chance and thus stock price as GIA is more risky in street view. But details of EU deal would be important.
Considering where SRP-9001 is at in the clinical pipeline and the risks with that drug Amarin should get multiples of what Sarepta got for international rights of Vascepa. Though I suspect Amarin will sell EU and not all international rights
They need to make a decision there by mid-year so any partner can get a jump. The sooner the better, let's have a forceful direction on EU. Either sell the company or make a deal and get some heavy cash flow for launch of US.
I've been inside company BO where a week before announcing the deal, after 6 months of work, the deal fell apart and was not finalized, actually has happened twice in 2 different deals. Until you have a final, signed BO agreement you must 100% go all in on GIA. You cannot do things that tip employees a BO is in the works, employees get nervous, look for other jobs and in this market you could lose key employees.
January is the prime timeline for a BO, if it does not happen then the odds drop each passing day and by June its the last chance before they are likely LT GIA.
Employees can get a sense something might be going on, unknown groups of suits walking through the plant etc... but much of that happened early last year so I think with de-risking they revisit the BO prices and then we will see but groundwork was laid and work done well before now so unless a new interested party shows up any BO should be fast to put together. Whether anyone reaches a price Baker Brothers, management and the board likes I have no idea.
100% sure there is interested party, unclear what the current bid/ask spread is on a BO, if it has not narrowed much from a year ago BO won't happen, but with the de-risking and known label the potential is there to come together.
You can see what they sold and have without having to click details here
https://www.secform4.com/insider-trading/897448.htm