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.
Exciting 90 days? Not this time- exciting WEEK ahead one way or the other
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm365571.htm
Jefferies Reiterates Buy on Amarin Corporation on Continued Positive Outlook
10/10/2013 11:30 AM
In a report published Thursday, Jefferies analyst Thomas Wei reiterated a Buy rating and $20.00 price target on Amarin Corporation plc (NASDAQ: AMRN).
In the report, Jefferies noted, "We outline several reasons why we remain positive on near term approval prospects for the Vascepa ANCHOR indication in advance of the advisory committee meeting set for October 16 and the expected release of the FDA's briefing documents on Friday (October 11). The ANCHOR Indication of mixed dyslipidemia is critical for long-term Vascepa sales growth and we view it as central to our AMRN Buy thesis."
Amarin Corporation plc closed on Wednesday at $6.30.
I think you need to read the RAND study. The time frame, the number of people, its relation to premiums, the fact the 30% was out of 45%, the fact it was 4 years like 15 years ago and we should be looking at long term impact etc...
You can bash the guy at truecostofhealthcare but not sure how someone disputes the actual numbers he presents because they have a personal dislike for him.
A better argument would be to dispute the #'s. Again, its hard to find independent studies on hot topic issues because people have an agenda on hot topic issues (See Fracking as #1 example) but the few I have found that seem independent seem to all conclude the same thing.
I'd gladly look at facts that can stand a little scrutiny that says otherwise. Until then the facts seem to support the position malpractice changes at the federal level would do little to curve health care costs in any material way.
It'd be great if malpractice was such a large driver, easier fix for our system which would be great, I am sorely unconvinced of this based on the data I've seen, sorry. If I see some solid data going the other way I'll change my view, I don't really have a position based on any personal experience, just trying to see the data and analyze it, so far that's how it comes out.
Layoff rumors? Hey I remember those, ended up being completely false just as these are. They are adding sales people, they are not laying off.
Prop 103 forced a 20% reduction unrelated to MICRA so the exact amount of savings related to MICRA is undetermined though compared to other states the premiums have increased less but then taking out prop 103 California is more average.
Here's a website with good analyses by a doctor also using actual premiums paid and good detail data and his conclusion:(again backed by excellent data)
"Apparently medical malpractice suits have nearly disappeared in most States so neither malpractice premiums nor suits appear to have much impact on medical costs."
http://truecostofhealthcare.org/malpractice
The biggest thing is 31% of malpractice claims come from 3 states and 52% from 6 states which, again leads me to the conclusion reached by independent studies that most of the states have malpractice reform and that any federal change would have minimal impact since it would only effect a few states.
The facts in this article are hard to dispute. Unless you are in one of the top 6 states, and more likely top 3 states (PA, NY and Florida) its hard to argue changes to malpractice will have much overall savings. I'd suggest you go through the site, as several other excellent articles on there.
Good discussion though. Always open to new facts. Interesting either way.
I don't disagree though I don't totally agree but I just don't see a consensus coming together on this federally to make such a radical change to the current system.
It would be nice to, at least test out larger ideas even if just in 1 state or something and then the results can be analyzed to see if theories are correct. Perhaps some state will come along and pass more radical changes to malpractice laws that get lawyers out of it but since most of the politicians are lawyers its an uphill battle.
Of course clinicians judging other clinicians can have its own bias but I think overall there is absolutely a better system than what we have but also think it needs to be executed at some state level successfully before we can get federal movement on this issue.
You make some good points.
Biotech's have had a pretty good run this year and last, could just be some overall sector rotation going on and computer models pick up on that and accelerate the trading and becomes more pronounced in the ore volatile stocks like AMRN
I agree there should be some changes but everything being proposed has been done in several states and there has been nothing close to 40% cost reduction after implementing. That's not a question, that's a fact so if there is 40% cost increase in malpractice and malpractice reforms that are supposed to eliminate this are in place and costs do not go down then factually there are only 2 possibilities
1)Cost of malpractice is grossly overstated
2)There is no known legislation currently being discussed or implemented at any level that actually fixes the problem
Which leaves the only way to reduce malpractice's 40% surcharge is
1)A law that no doctor or hospital can ever be sued
or....?
OR
The 40% is grossly overstated
Should have day traded, finally called the AMRN stock price right.
I see a discussion on stocktwits about the after Adcomm conference call being unusual and must mean something but have found several companies like ISIS that had post Adcomm conference calls so seems a common thing for many companies, seems more common to be scheduled ahead of time when they expect a positive judgement so not sure where they are getting that its unusual or possibly negative when it seems common though not 100% done and seems positive.
Anyone have any clue what time of day Friday the briefing documents are out?
Yup, technically should bounce near 6.30 but this stock is all over the place on a daily basis.
Adcomm run up will start NOW!...OK....NOW, Nope, How about NOW!
I don't know how much a difference that makes when we have those laws on the books in many states to limit malpractice suits and independent analysis has seen it reduce costs 0.5%.
1/3 have full caps and 2/3 have similar legislation Republicans want enacted federally so any changes to this would effect 1/3 of states only.
The reality is they order more tests to make more money and then say it was defensive. Simple as that. That as proven in several articles that did in depth reporting on health care.
Since we have malpractice limits in many states already its pretty easy to see the savings result and the facts suggest they have saves 0.5% so I tend to think the 40% number is not accurate since that would apply to 1/3 of the states it would need to save 133% of costs in those states to have a 40% overall reduction. Seems math wise that would be hard to do.
Even if what you say is true for you I'd consult the vast science out there that suggests there could be negative complications from too much DHA. Many smokers for years would say they have no lung cancer and they feel less stress and thus smoking is doing them well but over the long terms not the case.
Niacin is proven to NOT reduce cardiac events. EPA was shown in JELIS to do that. EPA/DHA-No proof in any study that it reduces cardiac events. There are zero long term studies of red yeast rice and it is basically a statin and has all the side effects of statins. The American Heart Association warns against using red yeast until the results of long-term studies are in.
I would tend to go with proven scientific studies of Pure EPA vs the negative side effects of DHA, the lack of reduced heart events of niacin and the untested long term effects of red yeast rice.
It would seem improving your lipid profile would be because you want to avoid any heart issues that would otherwise occur. If that is the case Vascepa is PROVEN to be more effective than either DHA/EPA fish oil or niacin AND red yeast rice there has never been a study to compare. So logically it would be concluded that Vascepa is first choice amongst the options listed.
When I said dumb it down I meant dumb it down as a basic comparison overall and not insinuating you are dumb as there are many conflicting studies on DHA and whether it is harmful etc...so could go on awhile discussing that but at a basic level EPA is better than EPA/DHA. I'm dumbing down the comparison for brevity sake not personal insult.
I don't believe that has anything to do with it. Debt limit raise is the 17th but they are postponing on shutdown which started last week. The Debt limit issue would not make FDA cancel anything at this point. The release clearly says shutdown which is currently going on.
Good find, glad to see AMRN got the go ahead that theirs is a go so we don't have that concern. It Also answers the question if Adcom would be effected, I guess entirely possible it could have been.
PDUFA clearly stated by FDA on the website as unaffected so once we get past Adcomm we have much of the uncertainty hopefully behind us and our Pre Adcomm run we missed out on dues to all this can be made up for Post Adcomm and Pre PDUFA.
Anybody know if trading will be suspended Oct 16 during Adcomm?
Yup, was going to post this AM about expect coming bear raids through Friday....
Next week can't come fast enough to get through this Adcomm and move on..
I disagree, if the stock goes up but stays below 9 it's a break even, if the stock drops below 6 it's a gain. The only way to lose is if it breaks above 9 and if you own stock you still make a high percentage gain on the covered call.
If they were betting on the stock going down then they should sell the $7 or $8 calls, no logic to sell the 9's.
Seems to me its a low risk hedge on a surprise negative Adcom. They are limiting their downside and still getting upside. With the stock up 30% plus its a good way to lock in a minimum profit but still play some upside.
If I'm doing a bear play with options this one would not remotely be the one I would do.
I expect unanimous but the reality is the votes only mean so much, if there are any negative votes the reason behind them would be more important than the actual vote.
I can't come up with a reason for denial so would be interesting the reasoning and how far that would go in regards to approval.
I think the market will focus on the details as much as the actual vote.
It's basically a break even play depending on the prices they did it which leads to the idea of a hedge. Again, hard to tell with option plays but if someone was full blown bear why sell the 9's and not the 8's etc...Looks on the surface a hedge
Interesting responses and the logic of Anchor have more stringent requirements than marine makes sense(hence Lovaza not approved for Anchor).
The person that died was confirmed Huntington's disease after autopsy and seemingly unrelated to Vascepa.
The bleeding risk: it seems they do not see a change in that, if there is going to be one for 52 weeks, it seems safe enough based on the ST to monitor it for people on aspirin over the long term.
Of course there will be questions and some things brought up to question, it's an Adcomm, they are not just going to bow down to AMRN as the greatest thing ever.
When you add in the Special Protocol Assessment for the trial nothing listed is even remotely a reason for a vote against.
Though I still believe Niaspan will be trending down overall as it has since the the study on heart events and its failure to prevent it in this case it seems the weekly drop is related to generic availability starting Sept 20th from Teva.
Huge drop in Niaspan scripts 73879 to 63182 in 1 weeks, over 14% drop in 1 week (assuming spreadsheet is accurate). Should open the door for increased Vascepa scripts going forward. It should become Statins and then Vascepa in Anchor population
Scripts 5930, 1.48% drop from last week, the other non holiday weeks that had drops followed the drops with at least a 5% bump the following week so hopefully that happens again and next week back above 6K strongly, though right now scripts are taking a backseat to Anchor.
Supposedly group fund buying causing early jump today.
It's a strange play if not a hedge. Already with the stock up, as you would expect going into next week, the cost of that play has come down, a pro option trader taking a bearish position would not have done that trade on that date. Just made no sense. So that then opens the possibility of a hedge against a long position or a trader going solely of some mathematical formula and not analyzing the stock in any way other than some personal technical analysis.
I'm not concerned it has ANY meaning, if there was some bearish info this trader had access to this would not be the play to make.
Unlike the other day this person is looking at a loss not a likely gain. Bad luck to them, Too risky a play in my book. Unless there is some other position involved previously does seem like a bear bet, seems bad timing, charts indicate getting some traction into next a Friday papers released, they could likely pay less next week for this spread. As stock moves higher.
Even though some good DD seemed to indicate that this would go on still relieved to get final confirmation. Briefing docs are out next Friday which is good, only a week and a day to wait for those. Anchor stuff is starting to really come up fast now.
Amarin Informed by FDA That October 16th Advisory Committee Meeting Will Take Place as Scheduled
BEDMINSTER, N.J. and DUBLIN, Ireland, Oct. 3, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it was notified by the U.S. Food and Drug Administration (FDA) that the scheduled advisory committee meeting to be held on October 16, 2013 in connection with the proposed Vascepa® (icosapent ethyl) ANCHOR indication will take place as scheduled despite the current Federal Government lapse in appropriations.
I think a vast majority expect approval from Adcom and there is a chance some questions and discussions are distorted to the negative, I also know many people are down that will want to get out on a rise and the people that bought on the dilution will have some sellers And then couple that with the debt limit raise issue the same week and see it might see 8 but more likely sevens and then slowly go up until December launch news. I think WS is more focused on partnership and sales than Adcom which is still months away from Anchor expansion.
So I think a nice run up from Adcom but not enough to get through 8 that week. Hope I am wrong but I do believe Vascepa is very heavily favored for approval and some if that is baked in.
I doubt it's related to owning the stock also which is why I lean toward a straight mathematical play. I just don't see Adcom shooting it above 8 in 2 days. The Theta is much larger on the calls and corresponding time decay on the calls will be likely much higher than on the puts. Honestly, lots of reasons to like the play if you have a position that you are unclear on Adcomm outcome. I'm long and expect a great Adcomm and feel this person will have a profitable play.
I also don't see any logic to the play for someone with any "inside" knowledge.
Options are used in so many different ways and individual plays are hard to analyze without knowing the overall strategy.
Option trading taken out of context is impossible to decipher.
Could be long the shares but sell point is $8 so getting extra premium and buying the puts instead of a stop loss for protection.
Could be a way to play a straight Put bet but also hedge it with the idea that even with positive Adcomm it won't go above $8. Stock ends the expiry at 8 they still make a profit. They profit as long as stock is below 8.10 or so. Seems a conservative play that can make money in any scenario where the stock does not skyrocket above 8 which is unlikely regardless of Adcomm outcome.
The person put no money up to make this play, seems a straight mathematical play with a slight downside leaning approach. If someone KNEW something they would just buy puts, they would sell 7 Calls not 8's etc...
Pretty obvious to me this is just a mathematical play. If you were confident this was going below 5 this would not be the option play.
AMRN touched on the fact they would have this advantage but was not clear on a time frame to get that accomplished.
I think its a matter of AMRN helping to educate the insurance companies. The insurance companies have a financial incentive as well since Lovaza has side effects and raises LDL so taking Lovaza over Vascepa will lead to higher overall medical costs due to the side effects so they should want to make the move rapidly as well but insurance companies are not famous for being fast at everything.
If AMRN has a BP partner with very good access to the insurance decision makers would go quicker possibly than AMRN people on their own. Currently if you order Vascepa with many insurance companies they will send you a note suggesting Lovaza because its considered a similar drug and Lovaza is cheaper. I know for my Anthem plan they do that.
Insurance companies should add information so doctors and patients are told that Vascepa is the preferred drug and clarify that for Anchor indication they should not prescribe Lovaza and that should happen pretty fast. Educating the doctors and patients about the change will be a product of advertising and the sales force.
Obviously if a doctor writes a script off label for Lovaza the insurance company is going to fill it first and educate later.
So, how fast it happens is going to be determined by AMRN and there success with insurance companies and success in educating doctors and the public.
NEW scripts will be much easier to be Vascepa over Lovaza. So with 30,000 new scripts of Lovaza currently happenning weekly and if 20,000 are Anchor I would hope AMRN reached 20K in anchor new scripts within 6 months of launch. Added to marine that gives them a shot at 2H 2014 profitability.
Advisory committee October 16, debt ceiling October 17. Not to be all negative but if they don't raise the debt ceiling any gains we see from the Adcomm will be wiped out and then some.
I would say, hey, no way they don't raise the debt ceiling, nobody is dumb enough to just default on the US debts but, than again, I can't believe we got to the point of a government shutdown.
I don't want to digress into too much political discussion but just seems to me a government votes to pay things they shouldn't have to vote again on spending the money to pay for what they already voted for. Common sense would dictate we just agree to pay our bills. If you want to change what we spend it on or reduce what we spend, get your message out, get enough people elected, and make the change, otherwise, accept you can't get your way.
Anywho, with the ride this stock has been on, it is very possible we have a great Adcomm despite government shutdown, unanimous approval vote, and 2 days later we are in the low 5's or lower due to government default. Wouldn't that be atypical for AMRN stock price.
I'm sure in many cases doctors will not feel adding Vascepa will be necessary since they love statins so much. Obviously if 100% of people on statins were going to be prescribed Vascepa the stock would be over 100 not at 6.50,
The Anchor Study seems to indicate Vascepa improves on what statins do when in combo with statins. There is also evidence that you can read through on this board that it does many things statins do not.
There are no side effects for Vascepa so easier to have someone take it based on the current science. Getting a very high percentage of doctors to recommend Vascepa to people with statins that are seeing good results on statins is not likely until Reduce It.
People on Anchor using Lovaza will be forced to switch to Vascepa as insurance will not cover Lovaza in Anchor once Vascepa is approved. Niacin scripts have dropped steadily since the study showing it does not prevent cardio events. So switching or dropping from Niacin is already happening. Niacin scripts are off 15% since the study.
Vascepa will be in addition to statins, AMRN is not going to go against the doctors love of statins and push people to move from statins to Vascepa, at least not until Reduce It results and, even then, a combo pill is more likely. So moving off statins to Vascepa is not really a plan. Moving from Niacin or Lovaza to Vascepa is the plan plus adding people in Anchor that are not willing to go off label for Lovaza.
In terms of Anchor market Lovaza does 1 billion total so we know the market is no worse than 1 billion total. Common sense would dictate the LDL issue with Lovaza and the off label ONLY for Anchor would limit the market somewhat. I think many analysts have put peak sales close to 2 billion for Vascepa.
The bad thing is we realize marine is a smaller market than anticipated, the good thing is we realize Lovaza is mostly off label which will all go to Vascepa pretty rapidly over 2014 thus Vascepa may reach 1 billion in sales faster than they would otherwise.
The launch of Anchor, partner, GIA etc... is the next big question mark to be answered and will go a long way towards where the stock is heading short term. You raise some good questions, much of the uncertainty you raise, WS has also. I think most of them can be answered favorably for AMRN but some(how Anchor launches mainly) are up in the air for sure.
I'm with you but WS is not a believer yet.
Superior product does not always equal superior sales.
Sure there are examples of companies in biotech at high multiples. PCYC has sales already and has a pipeline.
ALXN has a P/E of 66 and forward P/E of 35 but have sales already.
AMRN has no pipeline and has no BP partner and has 1 drug that many in WS look at as "fish oil". All these things WS does not like so they will need to prove a little more. If they do and sales ramp...
1 Billion a year in sales likely sees $30 share price. Reduce It positive likely sees $100 plus stock price.
WS likes to look 6 months ahead and very hard today to judge 1Q and 2Q 2014 sales-Will there be a partner, a cash raise for GIA Anchor, an increased sales force, a small initial launch...lots of questions that add more uncertainty to institutional investors.
You want many institutions to add AMRN to their positions, management has to clear up many questions they have, if they do we can see multiples like ALXN and other fast growing biotechs.
OB updated today, no change, I guess this is a benefit of government shutdown for us..
First OB after Adcomm will be the one to watch I think so the November 15 timeframe
I agree but I think the evidence leans heavily in favor of Adcomm happening and we already know PDUFA is 100% sure to go on so I don't feel 100% comfortable but 85% comfortable that these will happen.
Hopefully shutdown ends this week and no concerns, worst case we have 2 weeks to wait it out.
As of today FDA stated Adcomm is going on as scheduled.
Since this whole shutdown thing is new they will hedge with subject to change on anything as nobody is sure how this will effect things.
But as of today FDA says the Adcomm will happen, tomorrow, we will see what they say. . These are rare circumstances and I doubt the FDA 100% knows for sure anything that will happen past today.