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1Q is January to March, April not included, yeah it's part of first quarter of launch but not fiscal quarter which is what earning swill be based on and Q1 sales don't matter nearly as much as managements view on the future.
I can't say a short position is not defensible as clearly if you have been short since approval you are way ahead of longs.
I think there is some difference in approach between short term gains and long term gains. I think many of us are much better at long term investing, finding good companies with long term growth prospects and holding while others do a better job with short term trends.
Vascepa will do 500 million in sale sin 2014 or in that range, I would wager as much as I have that they will be in that ballpark.
The question is HOW they get there not IF to me.
-Anchor will have over 1000 sales reps and will expand focus to PCP which is not a focus now
-They need to raise money, maybe 300 million, maybe more for proper launch
-Options to raise the money are widely varied
-Partnership by itself has tons of variables-Minority interest, majority interest, just international, just domestic, Just Anchor and not Marine or REDUCE IT, just REDUCE IT-they have a tone of ways to handle this
-Hiring a third party sales force keeps 100% of sales in house but lacks BP backing and then how they finance the expansion becomes a question
-A partnership with BP takes some sales away but up front cash, sharing of launch expense etc. likely puts them cash flow positive 1-Q 2014
AMRN key starts from July to December, by 4Q starting they would want to have the direction in place so they can do a full launch upon Anchor approval. How they handle the Anchor launch determines everything-It's the whole kit and kaboodle, the whole enchilada--
So I see shorts not worrying until after July when negotiations start on Anchor launch AND the terms could end up with GIA with third party which WS won't like that.
When NCE is decided it should be positive as all info points to approval for NCE, just no idea of timing.
The CC for 1Q could be negative but based on analyst comments and shorts almost EVERYONE expects a bad 1Q and a bad CC and so bar is set really low.
On longs side: May could finally have real catalysts-NCE approval, good CC with good guidance, followed by July-Spet partnership for Anchor.
JELIS and what it was is not the point
Doctors have several options to try to reduce cardiac events. They have several options to control lipid profile.
When analyzing all the options you should, at some point, compare Lovaza to Vasepa.
Once price is not a factor it is very hard for anybody to make any argument to not switch from Lovaza to Vascepa with the already mentioned better profiles from Vascepa.
The other factor: cardiac events: several large studies have been done that show no correlation between DHA/EPA fish oil and reducing cardiac events. Of course FDA approved studies and all these other studies have differences but Lovaza cannot be used in High trig area for a reason.
Pure EPA, whatever you say of the JELIS study DOES show a benefit to cardiac event reduction and is more prominent the worse your lipid profile. Add to the science put out by AMRN on Vascepa, that is different than DHA/EPA fish oil, that changes factors that doctors think have effects on cardiac events.
When you add up all the science the preponderance of evidence suggests strongly that Vascepa will improve your lipid profile and reduce cardiac events and DHA/EPA fish oil will not. Why any good doctor would continue to prescribe Lovaza over Vascepa is simply education.
People seem to gloss over the approach of AMRN: mainly avoiding the vast majority of PCP's and concentrating on cardio specialists. Makes sense with small sales force and just the Marine indication but minimizes off label use which Lovaza gets much of its sales from. This all changes with Anchor where Vascepa will be cheaper than Lovaza off label and Doctors only prescribe Lovaza off label because the high trig market has no alternative(thus Vascepa being an unmet medical need) which will change.
AMRN has enough money to get through the year. They DO NOT have enough money for 1000 sales reps needed to launch Anchor. I have confidence the management team will minimize dilution and maximize value in the Anchor indication. Proper launch of Anchor could very well lead to 500 million in sales in 2014. The terms of partner/launch financing will determine a lot but they are not giving part of AMRN away for nothing.
You think it's the PDUFDA date?
The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.
I think people were hoping for earlier in 4Q but they are taking the full 10 months from submission
Though AMRN management said all along 10 months from submission so unclear if there was an expectation of sooner that has not been met and thus the stock being down?
8 Months to Anchor Approval, 2014, however they launch Anchor should ramp up very fast as they have plenty of time to figure out how to launch.
Realistically management keeps checking off the boxes, seems everyone is waiting for Anchor to get closer before putting in positions.
Can you imagine NCE granted next month, after all this time, and the stock would go down: LOL or cry?
Hopefully a good sign the official Anchor approval will come closer to October than December in 4Q.
Though 1Q CC will be interesting and WS perception of launch may not help the stock price I think with new NCE guidelines in place May 1 we may see answer to that FINALLY in May to offset
That's a pretty flawed analysis. I can use numbers and make things sound anyway I want also. Since Reliant BO was base don a market 10 times smaller than Vascepa's then 10 times the Reliant BO is totally reasonable.
They talk diluted shares but completely ignore inflation in the Reliant BO calculation.
GSK loses Lovaza in 2015 to generics, thus they lose 1 billion in revenue per year or 5 billion in revenue before Vascepa even remotely has a chance to have generics. They could buy AMRN for 5 Billion and worst case scenario they end up recovering the investment.
If Anchor can be sold at even double Marine they make profit, if REDUCE IT comes in they make a killing.
Comparing Lovaza to Vascepa because of the management ties and the fish oil similarities is what the amateurs like to do.
Drug A is and even at time of BO is
-Limited to 4 million people
-Has bad side effects for many people
-No studies show it prevents heart events
Drug B
-Has market potential of 80 million people
-Has almost zero side effects
-Has 1 Japanese study showing prevents Heart event
So who in their right mind compare Drug A to Drug B?
Technically the stock is still in a downtrend of lower lows and lower highs. I would not add until you see some reversal in technical's or news that warrants adding. The next bottom should be around 6.50 technically with the bounce to 7 or 7.50. So you can wait until it drops below 6.50, add and likely swing trade to 7 but if buying to average down you should wait until there is reason to believe a bottom which means either positive news or a technical trend change. Otherwise the trend says it will then go to 6.25 and bounce to 7, then go to 6 and bounce to 6.75 etc....Traders control much of the price movement and they've decided it's a downward trend so wait it out if you want to add.
Otherwise this is a stock to ignore the current price and check back in late 2013/early 2014.
Much will happen by year end, the biggie being how they decide to launch Anchor. How that goes down will determine whether we get there($15+) in 2013 or not.
It doesn't make much sense unless it has some seasonality in there for Lovaza that Vascepa does not have.
I saw someone posted on one of the boards, might have been this one, where they received a prescription for 30 days with 2 refills basically meaning good for 90 days. Is that counted as 1 prescription by the services or a prescription every time it gets refilled also? Or is it considered a refill in 90 days when it is renewed?
Just wondering as it seems refills should pick up 30 days after initial prescription but have not seen that happening and makes me wonder if it's 90 days out and won't see refills kick in until May. It just seems they get a large number of new prescriptions but little refills. Are they all 30 days so they are counting them as new prescriptions when they are refills or .....
Numbers don't seem to make much sense logically but until CC we need better weekly numbers for any stock movement in the positive direction.
I do think May 1 enacts new NCE guidelines so if not decided in May I have no idea what they would be waiting for. So hopefully by end of May we get
1) Better weekly scripts with higher refills
2) NCE decision finally
3) Anchor acceptance by FDA
4) CC with management's view on launch
Seems otherwise we will continue a slow downtrend with intermittent rebounds.
I'm with you on I expected to be long out of the stock but also knew the potential longer term in case BO did not happen. I do believe if NCE was granted quickly they would have sold the company right after
I don't think Anchor approval is moving the price for several reasons
1) It's 6-8 months away and investors have time and put money to work elsewhere for now
2) The company cannot launch ANCHOR on it's own so WS is waiting to see if dilution will occur or what type of partnership deal
3)There is still the FDA acceptance that needs to come by Mid-May, until then Anchor timeline still up in the air and no reason to invest for Anchor before then
4) Several Bio stocks launched and had poor ramp up to sales, bio stocks launching new drugs are strongly in the SHOW US you can do it stage for WS.
It was posted on several blogs and boards that IF there was no BO the stock would go to 8(according to some large investors) so I knew where it would be at with no BO but AMRN has a long story to play out. 2014 is HUGE, no Lovaza generic in marine for full year, Should be Tier 2 everywhere, in Anchor no competition.
How they go about getting Anchor launched is the key to the company, if they fail that then REDUCE IT can still save them but ANCHOR or bust for longs.
When it says they are required to retire I'm pretty sure all it means is they need to elect 2 new board members every year and not RETIRE from the board or else you would have major turnover every year and the intent is to make sure 2 board member need to be elected each year not be forced out so if the 2 that "retire" run and are elected again then there is no change.
It seems the 2 people that are leaving the board were required to be on it due to the investments made by their companies but there companies most likely have liquidated their positions at this point, at least enough of the position to no longer need to sit on the board. Simple as that, they were there to protect investments that no longer need protecting.
Either way them leaving does not mean much as AMRN has become about Anchor execution, how to raise money for launch(Partner, BO...?) is going to be the main focus before launch. Pretty clear the 2 leaving have no bearing on partner or BO once Anchor is approved.
I wonder if the Omthera poor IPO price and initial drop in trading has caused some boost to AMRN as people realize WS does not see Omthera as a threat to AMRN
AMRN management stated they will NO Go It Alone for Anchor so it's not new news, just a question of whether they will go Buyout, partner or use a large third party sales force. They WILL not hire more direct sales and try to do Anchor alone so I'm sure JPM is just reporting what I'm sure management is still saying.
I don't believe that means that at all.
Still expect GSK and AZN to be the top two potential suitors in a buyout, if they partner instead of selling then the field of potential partners will be much larger. I think, eventually, they plan to sell.
We are looking at December 2016 or thereabouts for REDUCE IT since they dosed in 2011 and estimated days puts it at December 2016 though the number of events will actually determine the close we can look at Dec 2016 as a ballpark. By time Anchor is launched they are 3 years from then to REDUCE IT results(assuming no interim results).
IF REDUCE IT is a winner then the stock is worth a fortune: $200 per share? It would be the only drug of it's kind and would be given to almost everybody at that point. Of course if it fails the whole market for Vascepa and fish oil could dissipate depending on how bad it fails.
However 3 years from Anchor launch we could see a 10 billion a year drug with successful REDUCE IT. So you can understand if management believes it will be successful why they want 5-6 billion for a sale before that.
Otherwise, partner for Anchor, wait out the 3 years, and see if you win the lottery or not.
This study is pretty flawed.
has been discussed on other boards but they admit its an observational study, only used 4 communities, did not use people that had potential for heart issues. Is nowhere near a study that could be considered FDA approved.
They say straight out "this is an observational study--it doesn't prove cause and effect"
It does seem to lead you to the face REDUCE IT will likely be successful, just seems to indicate DHA+EPA might be more beneficial though other, better studies do not indicate that to be true
Also they state:
Temporal changes in fatty acid levels and misclassification of causes of death may have resulted in underestimated associations, and unmeasured or imperfectly measured covariates may have caused residual confounding.
And
2692 U.S. adults aged 74 years (±5 years) without prevalent coronary heart disease (CHD), stroke, or heart failure at baseline.
So, it's a pretty flawed study that they admit is
1) Not a study
2) May not be accurately tallied
3) All versions of fish oil help
4)DHA benefits all seem to be mainly from 1 category of risk reduction
5) Tries to adjust for adjusted for age, sex, race, education, enrollment site, fatty-acid-measurement batch (1994–1996 or 2007–2010), smoking status, diabetes, atrial fibrillation, drug-treated hypertension, physical activity, body-mass index, waist circumference, alcohol use, and consumption of tuna or other broiled or baked fish, fried fish, red meat, fruits, vegetables, and dietary fiber over many years with poorly designed controls which could easily skew data
I do not find much medical merit in this at all even though it does indicate REDUCE IT will be successful and even though it says DHA is better than EPA.
Monday's script numbers have a few things working against it.
1) Good Friday likely lessened the amount of scripts written that day
2) Medicare coverage started April 1 so anyone aware of this would have waited until April 1 to refill.
Any chance we see a drop in scripts followed by a big bump the week after? Even if not a drop expect growth to moderate for that week. So Monday might be a bad start, though if NCE finally decided next week and is positive would not matter. I know it
s short term price talk but might be good idea to not try to add at today's lows if script #'s are going to be weak Monday.
Interesting Post.
IF REDUCE IT proves out I would suspect pure EPA and Vascepa will become a staple of everyone's diet as part of preventative medicine.
I'm not sure without the real need I'd be taking any RX in large doses until everything is proven but with the low known side effects I guess pure EPA could be an exception.
It'll be interesting to see what you get out of it though a 1 person sample, in the end, has little value but interesting nonetheless.
I am barely in the High trig category last year and have a physical next week so will get an update, have increased my exercise moderately from a year ago and sightly improved diet BUT if in the High area I will talk to the doctor about Vascepa though I would wait until Anchor approval and Tier 2 coverage on that before starting to take it.
Good luck!
Either they did the coupon or discount for you or it was covered by insurance or...? Did you fall in the High Trig covered area? Pricing makes no sense, much be more to how you got that price.
Once the Anchor sNDA is accepted AMRN will need to figure out how they are going to launch the Anchor population which will call for 4-5 times the sales force.
Clearly makes sense to discuss options with JPM. If they go the third party sales force route then they need to come up with money, if they decide to partner then they need to come up with a partnership agreement that does not give away the farm.
The other option is a Buyout but I think it is pretty clear Joe will not sell unless it is near $30 and unless the stock price gets to $15 (with NCE approval and Anchor approval) I can't see BP justifying such a price to their shareholders.
I suspect after early July they will really get into negotiations on launching Anchor(with the 100 million debt limit eliminated).
Whatever they decide would think they would want 3 months or so before expected approval for Anchor(and subsequent launch) to get everything in order.
Since they need money(dilution, debt raise, partner buy in, buyout?) to launch Anchor and have 3 options to pursue it makes sense to spend some one on one time with JPM, seems pretty obvious to me.
OH, OK. The analysts use Calendar Q's so easier to compare to their estimates using calendar. Your growth rate might be a little high but unsure as they seem to be adding 200+ Scripts per week on average. I would think the week ending 29th would be lower growth due to good Friday likely cutting into scripts?
Trend is good, unclear if Amarin had higher script #'s in mind that we are getting but as long as trend remains strong and Anchor comes into play all will be good.
There is only 1 more week of sales to be reported not 5 more weeks?
Quarter ended March 31.
Also, IMS reports, on average about 70% of actual scripts.
Also, AMRN sells to wholesalers which will be different than the # of scripts depending in what wholesalers ordered.
AND have no idea how they are recording discounts as related to sales so could effect sales # as well
So, basically until AMRN announcing 1Q sales we really don't have any idea how to use reported script #'s to calculate sales.