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Reduction in APO C III is in the presentation and what is being referenced which in higher level show 3 times chance of coronary heart disease.
Script numbers on Friday should be interesting for once, I usually don't put much meaning in the weekly numbers but with the holiday week numbers looking strong very curious if we get a major bump. Timing from added tier 2 should be about right to see a pretty good jump. Every new script is like compound interest going forward with refills.
I think we need about 22,000 scripts weekly in reported numbers to be near a break even point. Hope to be doing at least 10K weekly before Anchor launch which should then get AMRN to positive earnings some time in 2014.
I'll be glad to miss the first run-up, that means there will have been a run-up. I have my core position which can hold a long time of need be, its adding more to that where I'm much more conservative, I can lose all of my core position and I'm diversified enough won;t do me major harm, adding from here is a little more a stretch so willing to wait to see the trend change technically or some definitive news
Another delay on NCE.
Adds to my view no outcome until after Adcom.
Definitely getting close to the time to add-FINALLY for me. With dilution out of way, Quarterly will beat estimates, Adcom will be positive, definitely going to pull the trigger if scripts continue the trend the next few weeks. May wait until Q2 CC to see how they discuss Anchor launch, not too keen on the GIA language being thrown around after last CC JZ said was not going to happen where they hire sales force directly. If I get clarity I like on that will finally add I think.
OB says updated through June but Vascepa page says updated through May and no change there. main page of OB says updated through June so update is happening now it appears. No change to Vascepa page yet
Cool, is there a link somewhere to verify?
FYI for those that don't know per Google 74 day letter is sent On or before 74 days after receipt date of application
Expected outcomes of letter:
FDA communicates potential review issues
Sponsor responds to FDA’s concerns through amendments to the application.
FYI toady is day 83 from the press release saying FDA accepted.
JELIS ran for 8 years from Nov 1996 to 2004, the average follow up time was 4.6 years as obviously everyone did not enroll on day 1. There were 586 major coronary events out of 18000 enrolled, reduce it requires 1612 events from 8000 people.
However REDUCE IT is picking a subset much more likely to have an event. One requirement is having cardiovascular disease or have a high risk of it
JELIS just needed to over 250 cholesterol and excluded anyone with serious heart disease. For people that had heart disease history but not serious there were 355 major coronary events out of 3664 people that qualified. AMRN has very similar primary endpoints but more secondary endpoints that differ.
You only get about 800 events if you take the subset from JELIS which was for the number with history of heart disease the results of 800 events out of the 8000 would match Reduce it but AMRN is taking much sicker people.
JELIS was age 40 to 75 men and could be over 75 woman, REDUCE IT is 45 to no limit
JELIS was 1800 mg vs 4000 mg for REDUCE IT
JELIS eliminated anyone with serious heart disease or had a serious event within 6 months of first dosing to person while REDUCE IT pretty much eliminates people that had severe heart failure.
JELIS was an open study REDUCE IT is double blind.
Remember for primary endpoints sudden cardiac arrest and heart attack showed no difference in JELIS where unstable angina and non fatal coronary events were reduced 19 % and in reality unstable angina was the only significant difference and was reduced 28 percent in the subgroup with a history. There was no later follow up and since Angina is a sign of pending heart disease issues getting worse its possible a longer study would effect deaths.
REDUCE IT had average person with 5 times the EPA level of Americans and thus REDUCE it participants.
Despite no significant reduction in any area but unstable angina there were reductions with EPA group in most categories, just not statistically significant. With a higher dose, a population with much less EPA in system to start and sicker people its possible that data becomes significant.
What do you get from this-It is extremely likely REDUCE IT reduces unstable angina and thus associated hospital cost and worst case it has no effect on anything else but that still makes it a successful trial but leaves open the question on whether it prevents deaths long term. However it saves a lot of money by eliminating angina hospital visits thus it would be used in most cases with Statins. The data was really strong it prevents unstable angina even in relatively healthy people in JELIS so wholly expect that will repeat itself.
However you would have many people saying its not worth taking for the reduction in unstable angina without seeing a reduction in any other area.
Unfortunately there is no study being done on EPA alone and no statins, that would be interesting but statins are so established you could never find the people not on statins.
I don't recall him pushing BO at all other than one if three options. Royalty pharma was a totally different scenario that does not apply to AMRN, AMRN had non disclosures in place which would likely not allow them to divulge such info which is different than someone coming to you with an offer. I'm pretty sure from previous DD AMRN needs 90 percent approval not 60, so management needs to do the deal or no deal.
I also disagree more sales reps for Anchor equals a return you suggest as there is limited cardiologists to visit for Marine and trust the pros to know that 275 maximizes value.
Comparison to ARNA is bizarre.
ARNA took 3 weeks to get over 2000 scripts and then dropped in week 4. It is running comparable to VVUS drug launch which in 7 months is looking at 4000 scripts per week.
Now they have a 60 million plus market for ARNA versus 4 million for Marine indication so your talking equivalent to population ARNA has 200 scripts and VVUS 400 scripts compared to AMRN. They are different drugs with different pricing but comparing AMRN launch to VVUS and ARNA it's not even close, AMRN is pacing as a BB drug while the other 2 look like traction is difficult and tracking like 200-300 million a year drugs.
Analyst estimate 264 million AMRN 2014 sales and 95 million for ARNA.
AMRN is at a market cap much lower than ARNA which makes no sense but there is a difference between market and investor sentiment and reality. Your post hits it on the head, you think ARNA is doing great with scripts compared to AMRN when in reality AMRN launch is blowing ARNA away, eventually reality will sink into the market and market cap will make sense.....Anchor or bust...with successful Anchor launch its 15 stock minimum, Anchor failure and its sold like Omthera type money but let's not start trying to change reality because stock price is down
The public will get educated at some point and this headline grabbing story and its effects will be short lived. It is a terrible 'study' was not even a study, and will have zero effect on AMRN long term
I am not Not in there heads but they set up the sales months head of time to activate upon certain milestones. The sales were less than 10 percent if what they could have sold, obviously in hindsight they should have executed all options and sold everything and buy back now but they just decided to cash out some gains after years of getting a drug to FDA approval, I think I would have also quite frankly.
JZ made a mistake back at the time when he stated more people interested than he had employees but I believe that was in 2011 and he admits that mistake but thre other comments and press releases always listed 3 options and he made it clear in 2011 that 30 bucks was where BP needed to be. Once approval NCE was a big overhang and I believe with NCE approval within 60 days there very likely would have been some deal either BO or partnership, though I do believe the value of AMRN was not the same to BP as to AMRN.
They sold a small percent to cash in reward for getting drug to market, from that point on I do not really see much pumping of a BO.
WS hates GIA small biotech, they want a BP partner or sales that show profits and growth, without one of those 2 things WS and hedge funds do not want AMRN stock. Just time to sit back and see if either if those 2 things happen within the next year. I do not see much AMRN could do before Anchor to change those two things so not as hard on management, they blow Anchor and I will say they were terrible management.
Do we have Lovaza numbers for the week?
I'm a typical middle child so generally I weigh both sides and make a decision, if everyone is on one side I will play devils advocate and take the other side to pull out more info even if I believe in the other position.
I am very willing to turn on management in companies I invest in but that usually means I will be selling. People that have a strong negative opinion of AMRN management should not own the stock, simple investing philosophy for me. Does not always work out but if you believe a company has poor management and you are correct you would do well over time not owning these companies.
I also rarely if ever have seen companies that put out press release on a regular basis to correct misinformation ever lead to any sustained price increase. If there is a direct report on the company-say fraud- then by all means address it as stock price would collapse related to a direct assault on the company. I do not believe in a recently launched biotech that short term price of the stock is a high priority for management, especially in a unique case like AMRN where the real launch happens with Anchor.
If AMRN went to zero the losses, though large, for me would no have a material effect on my life and happiness. I have not always invested where that is the case and understand the huge emotional strain losses take on people and he need to lame management ur the shorts or whatever.
Good news is piling up for AMRN and Vascepa
-main competitor linked to cancer-same studies show your product is not associated
-5 months to launch largest market of any drug since statins
-Large continued patent defense
-cash now at level can take until profitable with proper Anchor collaboration
-They can destroy Lovaza in 2014-with a smart sales force they could reach peak sales of 2 billion rapidly before reduce it
So you get 15-30 a share with a normalized P/E from Anchor depending on partnership details by end 2014 AND with cancer scare for Lovaza generics in marine likely wil not hurt Vascepa
If Reduce It is successful you have a 10 billion dollar drug, simple as that, your talking 100 a share with successful Reduce it.
I think management thinks that also which is why they need to do Anchor right as that gives them positive cash flow through to Reduce it results.
Also remember the new option for directors are at 5.60 price to execute, so if they want to make money on those they need price up.
Personally, I find management experienced and most of the time I find them highly competent and professional though I realize they have made some mistakes. To me good management and great product so until I feel that changes I will stay in the stock, simple as that
NCE should be updated today, past history shows holidays did not eliminate a week from being a full week as it just means a full Monday thru Friday regardless of holidays so OB should be updated today or Monday. I expect another delay and no movement until after Adcom.
The DHA Prostate cancer link vs. EPA-slight help to prostate cancer should only help its cause as an NCE. Vsscepa clearly effects the body in a totally different way than Lovaza, clearly helps the argument it's a new chemical entity.
GSK might get sued for Lovaza and Prostate Cancer
http://www.druginjurylawyerblog.com/2013/07/prescription_fish_oil_lovaza_m.html
I highly doubt this goes anywhere as this recent news was not a study that was put together to judge DHA and prostate cancer but it will be the job of the sales reps in AMRN to educate the PCP's in Anchor that the same study shows no relation to EPA and prostate cancer.
Despite the reality a proper Anchor sales force will use this info to totally destroy Lovaza.
Despite the short term hit due to being lumped in with "fish oils" it just tales educating the doctors and then the public that they get all the benefits of fish oil they thought they were getting with no negative side effects with Vascepa and no other fish oil supplement or drug. That's the message they need to hit Anchor population with and hit it hard.
This news story could be a boon to AMRN if they can do proper sales force and advertising for Anchor.
I disagree a bit with the criticism of management.
"It must be execution" I think is simplifying way to much. Once they had to GIA 50-75% of the price drop was factored in. At that time they did state NCE was an overhang on negotiations. FDA deciding to review NCE procedures happened to coincide with Vascepa approval thus hard for me to blame management for not knowing the NCE delay was coming.
It was 6 months from approval to launch, not sure why you put 9 months, might be a case of a negative view point skewing reality? And it was never a delay, they gave a time frame of 1Q 2013 from pretty early on.
Pawning of all assets makes it sound like they sold some stuff when they just used collateral, collateral that would only come into play if sales for Anchor are disastrous. I don't see patents as collateral as meaningful in anyway because if that ever comes into play the stocks near BK already due to massive sales failure so won't own the stock at that point anyways.
Clearly they needed more money. Tying the recent dilution and the other raise is not an either/or, they needed both. In December they clearly thought they could work out some kind of partner/BO that involves cash coming in thus avoided dilution at the time. Now 7 months later they obviously feel differently thus the need for more money and dilution. It's very possible partners are low balling thinking
1)AMRN cannot launch Anchor alone successfully
2)AMRN cannot last with current cash situation
Without knowing what is going on in negotiations impossible to criticize strongly except everyone should agree dilution should have been done in December and then loan today. However, it's unclear whether they could get the same loan now, unclear what changed behind the scenes from December to July.
Also sales are not "above average" when you consider analysts had Q1 sales at 15 million and 1 year sales in the 90's and we have 2Q sales at 10 and first year sales probably 58 million.
I think those analysts numbers overestimated the sales potential and that sales are going almost as well as can be expected. Since they focus on cardiologists and within 6 months sales reps have seen all of them and 75% of them 5-6 times it seems 275 reps was a pretty good number. Since 50-75% of Lovaza is of label I just think the Marine population is not as big as people expected.
"something is wrong" seems a longs worry when things go wrong. Like shorts have inside info.
Well, they don't but they knew WS does not like GIA small biotech, they knew AMRN needed more cash. It went from 12 to 7.70 off the GIA news. Dilution takes another dollar off that market cap so 6.70 from going it alone decision alone. Sales estimates dropped before and after Q1 accounts for most of the rest, pretty simple.
So, there is some blame to management for the stock price, but since GIA decision and analysts original estimates being too high are a big part of it I can only really criticize them for not diluting in December at 7.70 vs, 5.60 now. They would never have gotten 12 as everyone knows dilution meant GIA which meant $8 price range. It's likely they get a higher price last July right after approval but I think, at that point, they thought NCE decision and BO. Again, with price near 15 due to BO talks unclear what price they could get investors in knowing dilution meant GIA. So. to me they blew 40 million or so in money they could have raised for same dilution but not knowing behind the scenes partner/BO negotiations its hard to say the December raise vs. dilution decision was a terrible one. Hindsight, yes, but facts of the December time frame....not sure?
Once GIA was clear, longs really had 2 things to support stock price going up
1) NCE approval-still delayed
2) Anchor partner deal followed by Anchor approval and good Anchor sales-Timing issue as months away
Some perspective is in order:
Stock price is down to $5 area which, if you are long, means you should have held off on buying the stock, shorts were right, reasoning aside, they called the stock price drop.
Many of us, I believe, were in AMRN expecting a BO before Marine launch. Once that did not happen, possibly due to NCE delay, possibly due to the high price JZ set, this turned into a long term investment. It also turned into a business judged on profitability and sales and balance sheet and other financial information that was really unimportant in a BO scenario.
Vascepa as a drug seem spectacular, the product they are selling seems, to people analyzing the science just an incredible product. There is a severe issue with lumping Vascepa in with "fish oil" supplements and Lovaza. The issue AMRN has now is they are a "prescription" drug for High trig only. It is very hard for them to rebut every fish oil study and story out there to physicians and the population ONLY being able to advertise to the Marine population and cardiologists of the same.
It would be a waste of money for a large educational and advertising campaign at this point. Once Anchor is approved then the whole ballgame changes.
We are 3 months from Adcom, which should give a strong indication toward approval, and then 5 months from Anchor approval and "launch". At that point education of the public and doctors becomes absolutely crucial. With the science out there should be 100% conversion from Lovaza to Vascepa.
Unfortunately this is a 2014 story, unfortunately this has turned into and Anchor story. There will be no BO before Anchor is launched. Many of us looking for the quick BO now have to deal with looking out to mid-2014 for something along those lines to come back into play.
Outside of this recent dilution(which management timed poorly-should have done sooner) management has done a very good job overall. They seem like competent management with a great product. To me that eventually leads to success.
Worrying about day to day stock price is meaningless as it all comes down to Anchor approval, launch decisions and Anchor sales. Nobody selling or buying today knows how that will play out. So worrying about the stock price does nobody any good these days. People need to accept the fact it's all about Anchor and until Anchor approval and then launch details and then sales, the stock price is meaningless.
As I've stated before I've not added since last year, will wait for August CC, at least, before adding. May wait until Anchor Adcom and then Anchor launch details. I am confident good management and a good product will lead to big things and can wait, people really need that attitude or this stock will stress you to an early grave.
The science says this is an all-time, top of the line, one of a kind drug. If REDUCE IT is successful, as science seems to indicate it will be, then longs will have their day in the sun, just need to wait it out.
With that in mind Anchor should make AMRN profitable in 2014, stock price should reflect that. A proper Anchor launch and no issues, a failure with Anchor launch and management needs to go. Seems simple enough but I'm sure people will fret about the daily stock price regardless of these facts.
It was not a fish oil study, it was a study totally unrelated to fish oil and then a third party went back to extrapolate other Sara from if without adjusting for any other factors, it's a completely useless study scientifically. Would not pass any scientific peer review.
However does raise awareness that may need to be studied but other studies that have been done show EPA is mildly positive while DHA is neutral or negative. There is not one study out there linking EPA to inceased prostate cancer risk that is a fact
Need a subscription to read study but based on that quote you highlighted every person had high DHA that also had high epa since basically it says if you are high in all 3 you have a higher risk and DHA has been shown before so having high DHA and EPA means nothing in regards to EPA, perhaps someone can read the entire study but since most people eat fish or take supplements logic would say that none of these people had low DHA and high EPA, so the headline does not answer anything about whether EPA causes cancer and your own quote you excerpted said Hi in all 3 meaning DHA was high in all the people with increased risk. But need to read the full study to understand and since the study was not for fish oil but just an analysis done after the fact with no adjustments for the individuals in terms of risk of prostate cancer for other factors all it does is make it necessary to do morel studies on this issue.
It's interesting study but can't find what omega 3 levels were at, in previous studies seems DHA could be related while this study pearly does not distinguish epa and DHA making it useless for EPA analysis. Also it was not a study done to determine this but another study they went back and analyzed this data without accounting for any other factors so scientifically basically inconclusive but need more study. I am sure the headline grabber headline won't help AMRN but doubt it has any effect on doctors suggesting fish oil or prescribing Vascepa
Sounds quite illegal and might, oh no, would lead to a lawsuit from those that bought into the offering, Best guess is they do not expect NCE decision this month and probably not until after Adcom but reality is they probably just do not know. If they knew they would be required by law to report it, especially with an offering, would have to be in prospectus so what you suggest us illegal.
Exactly why I have not added, need to see how they launch Anchor. It will determine almost everything through 2014. I think many investors are on the sideline waiting those how they launch Anchor. They can launch with GIA and current money but what I have been told it will be a slow ramp and not the way a proper launch if this magnitude should be done.
Whether he stock ends 2014 at 30 or 3 is 100 percent related to Anchor approval and then Execution. I need more details on their plans before adding anymore though I feel good with my core position as they screw it up BP will buy it for more than current stock price in 2014 anyways but not much more, they succeed and stock will take off. Simple as that
Lotriga sales in Japan will likely be insignificant as epadel is already there and doing 500 million per year which is also why Vascepa will never do much sales in Japan but the rst of the world wide open
Takeda reports July 31 so can get some sales info at that point
At that point you would think they would go into 2015 cash flow positive though GIA would have to be a slow ramp up with the money they have and, to me, they cannot do a slow ramp up for Anchor but pretty sure they know that and GIA would not be the approach they take.
Also remember it says based on "current conditions", there previous filings have stated they have enough money through Anchor and then thru mid 2014 and then they raise money and mention if GIA they may need more money so these statements are rather meaningless as current conditions change rapidly so I take those comments as mostly meaningless though helps with cash burn analysis though quarterlies are what us really needed for cash burn analysis.
It is done, we have 200 million shares fully diluted, not terrible for a biotech launching its first drug and hopefully this is the end of dilution, if it s not it oikely means GIA or poor Anchor sales, neither of which will be good news for the stock price
3 months to adcom
I like how people take snippets to back up their point but ignore the context.
It's right in their filing that they are in active talks to partner and if they cannot get a partner they will need to raise more money to launch Anchor.
To say "This is GIA all the way " shows a complete lack of comprehension in regards to launching a drug into the Anchor population.
If this is the only raise than it means 100% there will be a collaboration on some level involving another companies sales force. There is zero chance that this raise alone leads to GIA. To say otherwise is completely misinformed. It comes straight from the horses mouth that this raise is not enough for GIA thus there is only 2 conclusions...1: they expect to partner or 2: failing to partner will lead to more money being raised and then GIA.
Now they may raise more money later and actually GIA but that will come only if and when partner negotiations fail completely.
Right, we are talking amrn worldwide sales as long term numbers there
, AMRN is saying 40 million people for Anchor launch and 1200 sales reps, still comes to 5-6 billion market, US sales were 14 billion in 2009 for statins and long term Vascepa is worldwide I was not using future workdwide numbers related to launch cost, the US market for Anchor is, in theory 5-6 billion peak based on numbers alone, realistically I believe 2 billion peak without REDUCE IT. With success in Reduce it then 50 percent of statins peak worldwide I'd say for Vascepa peak so 10 billion peak If reduce it positive.
My conversations involved Vascepa launching with 1200 sales reps added plus being marketed to PCP and 40 million people and I was told 300 million was a good number to go with for GIA full bore, successful launch. Less than that is slow ramp and less possibility of success and would make no sense for such a large market to cut corners, market potential could be blown if not very aggressive on launch
PRWEB article google "statin drug market forecast" and says 7-8 billion dollar drop in market from 20.5 billion in 2011 to 12.2 billion in 2018
It says in the filing if they GIA they will need even more money but my figure comes from personal discussions with people in the industry.
15 million people take statin's, half of Men over 65 take statins, 17 billion dollars in revenue, will still be 12 billion once generics take over, that is the market we are looking to launch into. Based on people I've talked to this is kind of uncharted waters as this huge a market is very rare and thus very high cost in advertising, sales reps, training, samples, etc....
People that have done launches before have told me they would want 300 million available that they would be needed before positive cash flow kicks in to cover everything. Solely geared for launch and not other expenses.
If they were launching with REDUCE IT results they'd double that money needed as they see VAscepa as a market closer to statins if REDUCE IT is successful.
I don't expect Anchor to be bigger than 5 billion at any point and hope for 2 billion but expect it to get to peak sales fast, and then REDUCE IT decides what happens next.
So to get to 2 billion in sales by 2016 before REDUCE IT, means 500 million in 2014, over 1 billion in 2015 etc...apparently, from what people tell me that's an expensive launch and the people I've talked to maybe wrong but way more knowledgeable than me on the subject
AMRN says in presentations REDUCE IT adds 40 million people and Anchor adds 40 million potential people. I say Not true as some doctors want REDUCE IT before they would prescribe Anchor but it does mean AMRN sees Anchor as a 5-6 billion dollar sale potential population and REDUCE IT similar. I think they are way too high but clearly they see peak sales of 6 billion with Anchor and you need mucho dinero to launch that. Just shooting for 2 billion requires an expensive launch cost.
Reading the filing says right in there GIA means more money needed on top of this dilution
1)We are actively exploring collaboration opportunities for the continued marketing and sale of Vascepa as we approach the potential approval of Vascepa in the ANCHOR indication, assuming its regulatory approval.
2)If we elect to increase our expenditures to fund development or commercialization activities on our own, we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all, or which may not be possible due to our other financing arrangements
So they state right there IF they GIA they need more money and might not be able to get it and they ARE pursuing a collaboration.
Based on Elan comments I think there is a market for a deal for AMRN and they will get one, how good it will be depends on how many are interested but they KNOW they need a collaboration and it is a high stakes poker match going on for that
IF GIA for Anchor then there is more dilution/money raising coming, this smacks of a smaller partnership...Elan? with no money up front and shared costs and salesforce as they raised about half what is needed for Anchor launch.
If GIA for Anchor, this raise makes no sense as they need to go back and do it again, unless they are getting another loan....
I think it nixes any chance of someone buying in 25% of Vascepa but when you think about it, Vascepa is the only asset they have, taking money for a percent now, at beginning of Anchor launch, is like selling 25% of the company way below future value. So they might get 500 million for 25% and a combined sales force...no way anyone pays them a billion....so why take money up front?
So I think, to me, this leads way more towards a partnership, but a unique deal that involves no money up front, a sales force and royalties to them based on sales. I KNOW they would need 300 million to launch Anchor GIA, maybe more but at least 300 million and they have increased interest payments coming and the increased REDUCE IT cost...
Nope GIA can only be possible if they have some other financing...the financing today says GIA is out and up front payment for partnership is out. IF this is all the financing those two things are fact...if there is more financing then GIA can be on the table...but saying the raise today means GIA makes no sense since they don;t have enough money to do that after this raise.
I don't think people realize how much a PROPER launch that needs 1200 sales reps and needs to reach all PCP's and 40 million people will cost, I tell you if today's raise is it Anchor will be slow to ramp up...way to slow
The underwriters are not buying the shares up front it appears so they don't know how much it will raise yet and they can't pay off that debt now, makes no sense, interest payments are not bad through next year and they need the cash until Anchor launch details are decided.
I get 204 million fully diluted shares with all options exercised not counting the 150 million Corsicanto Limited notes due in 2032 which is unknown.
11.2 million of those shares of the 204 million are at 7.47 conversion per share so stock would need to be higher for those to count.
I would HOPE 2014 turns the corner to profitability, I would suspect we can use the 200 million shares or thereabouts as the number going forward for per share calculations.
For example: 800 million in sales in 2015 would be a 30-40 stock price with current dilution assuming normal P/E. If peak sales are really 1.8 billion then in theory this dilution would be a blip in the long run.
BUT STILL COMES DOWN TO ANCHOR SUCCESS, it is be all end all, we should see close to 500 million in 2014 sales, that should be the goal. if they do that stock will be fine, let's see if they can execute. They should not need to dilute again if the are successful with Anchor
Then it clearly leads to no GIA but makes unclear what kind if partnership as the money they raise from this is enough for anchor if some kind of partner deal but not enough for GIA, of course they can raise more money at Anchor launch also so in that way can be GIA still though would be dumb as they need a partner that has experienced sales force with access to PCP
I will wait out the week likely as dilution percentage brings to mid 5's and who knows who is getting out with the news, unless there is a great explanation form JZ II would wait, adding the short week script numbers Friday to the dilution and I think time to get in with more purchases is close but not here yet.
Well they have annual meeting tomorrow at 8 before market so they get a chance to explain this one, seems a misstep by management, should have diluted when Vascepa was approved and price higher, perhaps NCE delay , again caught them waiting and now have to do it late. Gives them over 100 million dollars plus for Anchor which may not be enough, not sure if this is to strengthen partnership negotiations or what but leads to belief they either were denied higher financing limit, hard to believe, or any partnership deal will not involve any up front payment but access to sales force.
I will say many companies I have seen do this right after an annual meeting so at least they did it right before just unclear the reasoning to. To me it is still not enough to launch anchor on own so why not wait until partnership details to make this move unless they are really struggling there. Hard to find any positive other than long term 2 billion in sales still puts price in the 30's eventually
I have been saying they need money for Anchor but thought would be from partner, will review what they say tomorrow as without there explanation hard to properly analyze this one. The holdup on what they were going to do for money is what has kept me from adding, now we mays see 4's and finally time to add, depending on management answers, maybe to they think NCE approval is this week so timing it ahead, who knows, not good on the surface but much closer to taking them through Anchor launch and profitability just poorly timed it seems
Current coupons and incentives only run through end of year but they could always renew it or do something new with Anchor launch.
It does appear Sales revenues is wholesale income minus all discounts and incentives.
2014 should be interesting, they will have maximized supplier diversity, thus increasing Gross Profit, plus eliminated most coupon incentives plus adding Anchor Sales plus a full year on Tier 2 most places. They will have all of 2014 with no Lovaza generics, no Anchor competitor of similar ilk.
They just need the proper partner with the right access to educating PCP's. if they do that I'd mortgage the farm and put it in the stock....just need to see what the Anchor launch partnership looks like. They have set themselves up greatly for a bang out 2014, now management needs to earn their money and not blow it and make a smart partnership deal.
The Company calculates gross product revenues based on the wholesale acquisition cost that the Company charges its Distributors for Vascepa. The Company estimates its net product revenues by DECUSTINGfrom its gross product revenues (a) trade allowances, such as invoice discounts for prompt payment and distributor fees, (b) estimated government and private payor rebates, chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives offered to certain indirect customers, including patients.
ther incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for Vascepa and who reside in states that permit co-pay mitigation programs. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for Vascepa’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish its accruals for co-pay mitigation rebates and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company’s co-pay mitigation rebates offered to date will expire on December 31, 2013. The Company adjusts its accruals for co-pay mitigation rebates based on its estimates regarding the portion of issued rebates that it estimates will not be redeemed. In addition, as is customary prior to the launch of new drugs, the Company provided certain of its Distributors with financial incentives to begin stocking Vascepa prior to the Company’s commercial launch of Vascepa in order to ensure that Vascepa was readily available to fill patient prescriptions upon launch. The Company anticipates that these incentives will only be required for initial launch quantities of Vascepa stocked by Distributors in January 2013. The amount of these financial incentives is recorded by the Company as a reduction to revenues on a pro-rata basis for each of the bottles subject to such financial incentives.
December 7, 2011 was first dosing per press release at the time.
If they PR'd tier 2 for Aetna the stock price would be no different so lets not correlate lack of Press Releases and stock price here.
If its on message boards for hours on the internet WS knows about it its just not something worthy of moving the stock price. Especially July 4th week, if anything wait until next week for any Press releases but this is not a material stock mover of an event.
Not sure there will be any stock moving catalyst before Adcom. Go enjoy the summer and come back then.
At the last CC they said they would update Tier 2 status each quarter and not in between so not really a surprise or unexpected.
Wouldn't hurt to put out a release when it's a major carrier.
BUT would not effect stock price at all so not sure why people care so much. Quarterly is fine for events that will not effect the stock price but to each there own.
Still Tier 3 at Anthem.
I have Anthem for insurance with my Tier 2 cost $35 and Tier 3 is a 30% coinsurance
Vascepa is 57.83 per month and Lovaza is $35.00
Vascepa is 150.97 for 90 day mail order and Lovaza is $70 for 90 day mail order so its more than double for a year of Vascepa at Anthem.
When you plug in Vascepa in the website it automatically comes up with:
Other Drugs that May Cost Less and then lists Lovaza
I'm curious once Anchor approval if they will modify that page, though I guess at that point Lovaza will not be cheaper(until 2015 generic) so it won;t give you that alternative listed anyways.
Does not mention any rebates or coupons on the Anthem site when searching for drug cost so still some work to do, as expected, but Tier 2 in marine will make a huge difference in switching people from Lovaza and with the right approach they should make insurance companies well aware of off label use that Anchor switching should be near 100% with the right sales force once Anchor is approved.
So good progress, Anthem's last PDF drug list update seems to be 04/13 so not sure if they update quarterly or what on drug tiers or if online is updated daily and then they put out a new PDF list quarterly. If and when I see a July update will recheck.