Late 2017 is REDUCE IT results so they need to get there, actual FDA approval will matter but if they get a positive results sales will jump dramatically and make positive cash flow instantly well before FDA approval, if they can get to late 2017 and then get positive result they will be OK, question si can they get to late 2017? 3 more years.
The recent Harvard/MIT study that concluded below came out so recently so probably too late for documents but is the newest study on the subject and goes directly towards what FDA is questioning
The researchers suggests that, even as the exact causal mechanisms are worked out, targeting triglycerides for treatment may be an effective strategy for reducing heart disease risk.
“Clinically speaking, one of the ways to prevent a first heart attack or to reduce the risk of a second heart attack in someone who already has heart disease may be to treat patients with medicines that lower the levels of triglyceride-rich lipoproteins,” Katherisan said. “Some drugs that target triglycerides are already being tested; it is now a matter of finding the right mechanism of lowering triglycerides that will effectively reduce disease risk.”
I emailed the editor and they changed the headline to read:
Amarin Fish Oil Pill May Depend on Heart Study, FDA Says
instead of "Amarin Fish Oil needs Heart Study Result, FDA Says
A little late but at least it is changed. The stock went from 5.75 to 5 after that article came out, I think it helped with the panic selling.
I read the full brief, not as bad as the headlines, still expect positive vote mostly unanimous, devil will be in the answer to how confident they are Vascepa will reduce heart events.
My guess is positive Adcom voted for approval close to unanimous but the level of certainty on it preventing heart issues will not be overwhelming leading to a mixed reaction and the stock needing to wait until December to see which way FDA goes.
They said docs say MAY require outcome study, the headline is misleading and right after was the drop under 5.50. Ridiculous lie to say "Bloomberg confirms heart drug study needed"
From previous CC:
The FDA, through our SPAs, approved our placebo. And over the years, many companies have used olive oil, corn oil, mineral oil, we really think it's much ado about nothing. So we really don't see a difference.
So I see that being questioned and then answered with no issues
Yeah it needs to go to 5.33 or lower or he loses money. The 5.50Put ask is currently 7 cents and he paid 17 so already down 10 cents per Put. If price stays above 5.50 it's 100% loss
He paid an average of 17 cents so needs it at 5.33 to break even. Assuming it was not a hedge and a straight bear play looks like it's going to expire worthless. Volume has dropped each 10 minutes, would take a ton of volume for Put buyer to win
Any self funded programs would continue and I believe drug companies pay money to have drugs reviewed, alot of money and drug companies do not like paying them so I think they would be upset to pay huge fees tog et there drugs reviewed and then told they are not being reviewed. But hard to say if the money collected covers Adcomm's and PDUFA or what/
Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992. PDUFA provided a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues from these “user fees” were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. Consequently, the FDA was able to reduce review times of NDAs to 12 months for standard NDAs and to 6 months for priority applications that involved significant advances over existing treatment. As a result of PDUFA, the timing of U.S. drug approvals began to mirror that of the rest of the world.
n 2014, the user fee will be $2,169,100. If you assume that as many as 50 NDAs are filed in a year, $100 million of FDA funding is by the industry.
They can't sell Lovaza or the generic to Anchor once Vascepa is approved. GSK currently sells off label and have been doing it with the sales force from day 1. Buying AMRN always made sense. Right now they will lose 1 billion in revenue per year possibly starting next year if generics come out and AMRN gets Anchor.
They could easily buy AMRN for 5 billion and recoup all the money rapidly by replacing Lovaza with Vascepa, tell current doctors in Marine it has no side effects like Lovaza and then have Anchor market to themselves until 2020 and beyond, not to mention the large boost from Reduce It-assuming positive results.
They only recently added side effects tot he label for Lovaza so gives them a perfect scenario to mention the new side effects and introduce a replacement without side effects.
Marine is likely selling 300-500 million per year with Lovaza so generics have a maximum revenue of 300 million, but they sell for cheaper so 100-300 million market for generics. Take out some for the people that prefer no chance of side effects and you get maximum 200 million in generic US sales. Plus some international sales. Peak Anchor sales are expected near 2 billion, peak Reduce It sales could push that number 5 times as high. GSK could get Vascepa sales to 2 billion within 1-2 years and recover the investment in AMRN in 3 years or so,
So, yeah, it makes SENSE for GHK to buy AMRN, but that doesn't mean GSK is smart enough o do it.
Put selling is a great tool, can sell OTM puts and lower basis on a core position, can also use them to get into a position if you think the entry price us slightly high. It is stool that as a place and works very well in many scenarios.
Rate of return us more important than dollars but would think that us all hard to calculate unless you always close the puts, even at a loss, otherwise you need to factor in getting the stick, selling that or calls against that etc...not sure how you arrive at 35k
I doubt any BP would make any moves without a partnership deal in place and one in place would need to be announced. In January 2015 or earlier generic Lovaza is here. That is just over a year, add to that the whole of 2014 will entail Lovaza fighting an insurance denial on all off label use. So it seems GSK is planning for the clearly coming slowdown in inventory needed. In just over a year generics would steal much if the market they ave left which s likely very little once Anchor approval since most sales are in Anchor. To jump to AMRN partnership makes no sense. They cut back on Lovaza and then PFE scoops in with a better partner deal and they look stupid. So I say almost zero chance this is related to any AMRN partnership and solely related to the obvious comin drop to Lovaza sales. Not that GSK is out as a partner, just that no manager would decide to cut inventory and advertising on a drug because they might partner.
Makes sense to up price hen you have a short window to maximize revenue as product s going to be obsolete within a year plus
GSK should buy AMRN but nothing they are doing is any evidence that is happening. So up price, cut inventory makes perfect sense with a product with limited shelf life.
Makes sense in hindsight. Going back last 14 weeks, 7 of them are negative for new scripts and 7 are positive and last week was positive so reasonable expectation is little gain in new scripts this week, likely a down week. Have not seen the breakout between new and refill but trends suggest little increase in new scripts for the week and then the continued steady growth of refills. Refills have grown almost every weeks so would assume a drop in new scripts and an increase in refills.
Would like to stay over 5K, they had a good bump last week, many times followed by a small drop or minor increase, realistically about 5200 would be my expectation but as long as over 5,00 would be OK
Anchor was done with people on statins so approval will be for people on statins, however 40 million people are on statins and if you are at risk you will be on statins so does not really matter. Yeas, some doctors would prescribe to people not on statins but likely would be off label. Since they have not done studies without statins label is likely to be used with statins thus the 40 million population they keep mentioning equivalent o statin users. With no side effects they will get use n people that can't take tastings or don't want to due to side effects. Statins are loved by doctors, trying to find people with high trig not on a statin for a study would be near impossible. Statin market and Vascepa market is the same at 20 billion plus potential sales and if Reduce it us positive Vascepa will have equal or better outcome study than statins and will likely be prescribed as a combo drug and replace niacin in any combos with statins, being on statins as a requirement is no detriment since almost anyone getting Vascepa would already be on a statin
They chose sicker people for Reduce it because the subsets of JELIS showed the sicker they were the more benefit they got, in fact if you just take the healthiest people there was no statistically definitive benefit though logically it would take more than 4-6 years to show any benefit in healthier people.
That message board has always been a joke, nobody is vetted, everyone claims to work for the company they post about but the posts are then very unprofessional.
They hired Shalabay in 2012 and added to management team and per filing end of April 2013 was still listed as VP Sales. Linked-in still he is listed as Amarin Corp from Aug 2012 to present. Aaron Berg is listed as VP Marketing and Managed Care at AMRN.
When they file 2Q reports we can see if Berg replaced Shalabay. Not sure any of that matters.
It's possible he was replaced in July but not like he got sales so high he is indispensable. It's not like there are 20 different people posting on CP to give you a sense of AMRN and what is going on. For the most part, unless something new comes up CP is not really helpful in regards to AMRN sales.
If they GIA it would mean they hire a third party sales force, they will not have 275 reps for Anchor, they already stated there will be over 1000 sales reps for Anchor so they will hire a third party sales force OR partner but they will not have 275 reps for Anchor. They will not hire 1000 more reps is true but a third party force is much cheaper as those reps have existing relationships and they sell other drugs so they don' t just sell Vascepa.
So cost is cheaper but results are less than a partner or your own sales force generally but it's a route that fits in with cash flow.
So mainly 2 options for Anchor
Partner with BP using BP sales force
Or hire third party sales force on commission basis
Either way there will be over 1000 reps selling Anchor, if not JZ and AMRN management would have to be checked for brains because there is no CEO in the world that woud launch Anchor with 275 reps, even JZ stated that won't happen so to say it will Is just fantasyland. LUDICROUS EVEN.
It's simply valuation. At 200 million fully diluted shares(which is higher than actual at this point due to possible convertibles in the future but good number to use) you can start calculating company value. WS likes to try to look 1 to 2 quarters ahead. For biotech's 3-4 times sales is a good market cap estimate though fast growing biotech's get much higher multiples depending on growth.
We are looking at first 12 months sales at about 60 million in sales so 6 months from now company estimates to have 60 million in sales. AMRN now has a market cap at 200 million shares of over 1 billion so company valued 16 times sales. A fast grower biotech like ALXN is currently at 17 times sales So AMRN is at the top end of valuations.
In 2014 they are on pace for about 120 million marine sales. Anchor is the reason for the high valuation as sales estimates for that are all over the place. Anchor sales should be 2-5 times Marine depending on launch success. So 240 to 600 gives 340-720 in sales in 2014. At 340 you get a 20 P/E that puts the stock likely around 5 dollars.
So the company likely needs 500 million in sales and a 20 P/E for $15 stock price. That is more than 6 months away. Current 2014 estimates are 264 million which is right around break even.
WS does not values solely on the drugs potential. This COULD be a BB drug but history of small biotechs going alone is not great. If the company MEETS 2014 sales estimates 3.5 times sales equals a stock price of $4. SO if the company can't show Anchor is going to exceed sales estimates for 2014 then the stock will find fair value around $4.
If they can get a partner that decreases the expense of the Anchor launch and is able to push sales near 500 million then you get $9 minimum on 3.5 times sales but likely get a much higher premium due to a higher P/E, faster growth and better prospects. So $15 w/ BO $30 potential on growth.