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Really? Can you find that info because on June 6 AMRN said the FDA had not even told them an ADCOM was coming or not so this would be news after June 6 and have not seen it. With PDUFA date of Dec 20 seems a little late to be doing the Adcom in December?
Catalysts could come before December to move the stock price.
Clearly we are in a trading range and awaiting Anchor news. So only Anchor news will really move the stock up.
An Adcom in August or September could move the price. Partnership news could also move the price.
Both of those could happen before December. I think if they still have not partnered and Adcom is not needed by November we should start to see a run into Anchor approval. Maybe to $10 and then it all comes down to Anchor and how the launch details come out.
Hopefully they get several interested parties and can leverage for a really good deal. I think whichever company partners is also likely BO candidate maybe a year after Anchor launch so Anchor launch partner deal is probably the biggest, most important decision management will ever have to make.
Adcom early would be very helpful in closing partner deal before November. Is plausible either way that a partnership deal is struck before November to have time to prepare the Anchor launch with partner.
2014 still looks like conservative 100 million marine, 300 million Anchor, proper sales force 150 million marine 500 million Anchor, IF GSK is partner and decides to replace Lovaza with Vascepa before Lovaza generics hit 2015 then 1.5 billion plus is plausible in 2014. Not likely GSK does that but you never know.
Expected refill numbers next 4 weeks
Using the refill to prescriptions I get
6/14-1620
6/21-1805
6/28-2044
7/5-2145
7/12-2337
In reality Expect 7/5 down with holiday and 7/12 up but total for 2 weeks about 4482
FYI total script expected #'s with 3% weekly growth on new scripts
6/14-4139
6/21-4400
6/28-4717
7/5-4898
7/12-5172
Again with July 4 on a Thursday likely that week we are down but trend would likely pick back up week after
With underreporting and zero growth from July 12 that's 60 million per year in Marine Sales from July 12 forward. Of course there will be growth but that's a pretty good pace for a launch.
I bet on refills being up much more percent wise next week, think this week is an aberration on refills, will definitely break 4K next week on the way to 5K. I think the run from 4K to 5K will be quicker than 3K to 4K. Refills will start compounding on themselves.
They are coming off a holiday week but up nice overall from week before. It seems possible with the week before holiday people refilled scripts before going away and thus pushes some of the refills from today's number up a week, should be back to higher growth on refills next week.
Going back 3 months we average close to 2,000 new scripts a week which is about 8666 per month factoring 52 weeks divide by 12.
More recently 2500 scripts or 10,833 per month NEW scripts.
Without knowing 90 day scripts vs 30 days hard to get a percentage but next week there are, in theory 8,000 scripts than can refill.
90 day scripts won't be heavy refills until July
Based on adherence rate for cholesterol drugs(closest comparison I can find) about 55% always refill and another 14% mostly take that type of medication religiously you get from 55-70% refill rate to be expected.
Based on that you get a minimum of 4400 refills coming for any given week based on 90 day vs 30 day. I would think 90 day prescriptions would be common with a drug like Vascepa but no idea.
Next weeks refill number should be around 1620 so would need 2380 new to get 4K
Hey, we did not have a big drop with NCE delay? I guess WS is as sick of the wait as everyone else.
The percent of effort and percent of PCP's reached is low and then factoring in that it takes 4-5 visits to convert into many scripts...
With a small, lower cost sales force it makes sense for Marine to concentrate as they are on cardiologists and slowly hit some PCP's. Most Very High trig patience would have a cardiologist where most High Trig will be PCP.
Thus the reasoning behind a partner for Anchor and the cardiologist concentration for Marine.
If management does this right they get 100% conversion of Lovaza off label by end of 2014. The right partner and sales force and that is doable, even likely. Management needs to not screw up Anchor partner/launch and Vascepa will be a BB drug. Simple as that. Let's hope they know what they are doing.
I think I'm there and have been, still pay attention once a month but no decision is OK as no BO is coming any time before Anchor anyways and NCE is BO related value.
Countdown is on to Anchor partnership. Feeling good about the second half of the year, catalysts are within reach finally.
Still the catalyst is getting closer.
December 20 I know for sure, before that still not sure when the range bound stock price starts to move. If we get an Adcom date may shoot for then, combo results maybe, NCE for sure and then script growth though they will not attack PCP's in force until Anchor so expect slow and steady, doubt scripts move the stock big before Anchor.
But within 6 months catalysts will be there.
The standard rules are they announce decisions through OB. it's not clear to me that they cannot let AMRN know a decision is coming without telling them what the decision is.
This is also a unique case with a unique delay and new rules on NCE being implemented so not out of the realm of possibility they make an exception in this case.
I believe AMRN is in contact with FDA regularly and believe they will know when a decision is pending in OB update.
I could be wrong and they won't get a heads up but that's my view of it.
Someday we shall see..maybe... LOL
There is no set time, FDA updates are random, based on past history between 1 and 3 PM is likely though there have been months where it was after hours, 1 month it wasn't updated until Monday, 1 month it was early 2 days etc...
So no set time but 1-3 this afternoon is a best guess.
I continue to believe AMRN will be notified a decision is pending with the OB update once it is finally going to happen. That's just my opinion but I believe we will know before the update that a decision is going to be happening and since no such notice I go with another delay, onto July. July should be July 12 as 2 full work weeks equals July 12, and before anyone says anything Holidays do not make it NOT a full week.
Maybe I will be surprised with update today but doubt it at this point.
Looking forward to 4K scripts with this weekend script data, with under-reporting and no growth from there the next 12 months is 45 million in Marine Sales going the year forward. Of course we will have growth and of course once December and Anchor roll around they can expand to PCP's with the proposed partner which will accelerate Marine sales in 2014 in addition to the large Anchor Sales.
Anchor partnership details will determine the stock price 6-12 months from now and probably give an inkling who the eventual owner of the company will be.
Excellent summary and post!
It's possible, not convinced. There have already been detailed analysis as to why it's an NCE that would past muster without any loop hole so not sure why they would need to use some loop hole when not necessary.
If we don't see NCE decision by August I may change my tune as then i have no idea what would be holding it up.
Either way, most avenues lead toward positive NCE decision but like to have official announcement either way to put it behind us.
Still hoping for positive NCE decision Friday, followed by 4K scripts and then a nice Monday next week. Would make for a great Father's Day weekend.
Will AMRN miss combo deadline?
Management been very good at coming through but I did notice the analysts stated combo data in June OR July when the company has been saying Q2 all along. Wonder if the results are going to get pushed to July.
6 Months to Anchor, downside pressure to stock is running short, they WILL have some sort of partner deal for Anchor launch and I cannot believe they will fail in getting a good one.
Anything is possible, if it is delayed again perhaps you make some sense.
However, many months ago a draft letter was circulated per AMRN filing. Also,There was an overhaul of NCE guidelines updated for May 1.
Anchor is not approved or expected until December. If it's denied they still need to decide on NCE for Vascepa for Marine so an AdCom panel that is convened for Anchor should have ZERO bearing on NCE.
The guidelines also state "or explain why not discussed" which is easy, there was no Adcom thus could not be discussed, that passes the test of the guidelines.
So Panel not required for NCE...FACT
NCE needs to be decided regardless of anything with Anchor..FACT
Company stated FDA has not told them there will be an Adcom...FACT
Adcom guidelines recommend an Adcom panel for a drug like Vascepa for Marine indication...FACT
Too much speculation here, AMRN considers Vascepa a new type of drug(fish oil) for an indication(High Trig) that has never had a drug of similar type for the indication. This almost always requires and Adcom. Thus they are preparing for it. It's as simple as that. People want to call it a new population but AMRN says it's a new indication and that IS accurate. High trigs is an indication with NO fish oil drug EVER approved for it. Adcom recommendation say you should have a panel in that instance.
The most likely scenario for the delay is the failure of past NCE decisions that needed to be reversed coupled with a brand new committee to review NCE procedures, followed by updated guidelines established in May. With that in mind NCE should be done within 60 days of May 1 if logic finally prevails.
If it is not then perhaps I'm way off and this speculation is onto something but to me the it does not pass the logic test.
I've seen those types of option plays too many times to put any meaning behind them. Many times they are hedges so a large short position can hedge against NCE for example.
I would expect more action with this week Expiry and even more action with the Monthlies if there was some leak.
Could also be a long investor selling covered calls expecting another delay since 35 cents or so for 10 days is a pretty good return for covered calls.
Overall I put it as a hedge or a calculated gamble and nothing more.
I don't find that discouraging for Marine indication. Most launches have up and down weeks, especially for new scripts. Vascepa being a strong refill drug that people take over the long term will offset a lot of the weekly new script volatility which is really quite normal
Sales for Q2 on pace for just over 9 million, above 8.34 estimates.
I'm going with 1700 refills and 2300 new and 4,000 total for next week's report.
Scripts per AF week of 5/31: 3,336, -2%, per Symphony
I expect next week #'s to be right about 4K.
I believe in the recent presentation breakout AMRN said scripts are growing in all weeks but holiday weeks so this is expected
My analysis
Pharmacies are open 7 days though you'd expect a small decline in refill growth with the holiday weekend so the big increase in refills is REALLY NICE.
In terms of new scripts you have doctor offices closed Friday but you also get less scripts written on Fridays generally.
485 per day for 4 days and then about 355 short on the holiday Friday to equal new scripts from previous week. I think new scripts would have been slightly down or flat but hard to say. I think the trend has been for new scripts to be plateauing a bit but the cumulative effect is pushing refills way up.
Highlights I stole from from Stocktwits
1940 NRx s vs 2295 (short week) and 1396 Refills vs 1106 Last week.
Day-to-day basis, there were 654/TRx/Day previous week, 834/TRx/Day this last reported week. 27% increase on a daily
So refills up 26%, NRx s down 18%
Phramacy is open 7 days where doctor
With a short week need to add some percentage to all script numbers to accommodate for the holiday. Not sure what that number is, obviously no more than 20% but probably closer to 10. With one less day in there tough to get any meaning, monthly numbers are better and comparing full weeks is also better for a trend. If below 90 this report and then above 90 next report that makes the drop not meaningful
Yes, meant no drugs of this type. It's a new drug for a new indication. FDA guidelines recommend a panel for this situation. It is "recommended" but not guaranteed and my best guess is Joe Z knows the guidelines say that and most of the time FDA will be conservative and follow with a panel when recommended so they are preparing since based on FDA protocol a panel is likely.
In the FDA guidelines there is nothing in there that would recommend a panel for the Marine. Lovaza was already approved for the indication. There were no safety issues. So based on FDA guidelines no reason to have a panel.
Not many drugs come up that target a market with no other drug in that market like Vascepa and Anchor. Also add in the fact Lovaza failed to garner Anchor approval it makes sense to have a panel for a drug with those guidelines.
Pharmakon was 100 million in December. They owe back as much as 150 million in future revenues and interest but the loan was for 100 million.
He said they would not launch in Q1 and they did so he has not been spot on. He's been wrong on AMRN way more than right.
To add to this, the panel confirms what longs have said all along. Anchor and Vascepa are an unmet medical need. It is a drug unique to the class. It is an all new drug focusing on an area with no competitor and no other drug for its intended Anchor indication.
It seems the FDA agrees or there would be zero reasons for a panel.
If you go through the list in the FDA guidelines that's the only one that would apply and Joe was quoted as saying
"It is the product that will be first in this indication for this class"
So Joe seems to think it's a new indication
Otherwise I could not find another area in the guidelines that applies so the facts being
1) Joe said it was because of that
2) No other guidelines apply
I'm going with the reason why they are having a panel is because FDA is evaluating a medical product for a significant new indication.
High trigs is a NEW indication not a population. There is a population that is ever changing that has high trigs but high trigs is the indication. They are not applying to the drug to only these 40 million people it's to anyone with High trigs(thus an indication)
I see this as 100% pretty basic. The CEO says exactly why there will be a panel and then the guidelines, if you read them, only have 1 spot where it would apply to AMRN which matches exactly what the CEO said.
To me it's case closed on the reasoning.
Scripts this week include a holiday so might be down overall and then rebound next week but WS also knows there was a holiday so need to extrapolate out an extra day which likely will equal short term growth of scripts so will be another non-event. Since the Friday before holiday was likely slow might still see a small bump in scripts.
The next 12 months at zero growth is 50 million in Marine sales and there will be growth so 2014 being the big year for Anchor they should get easily 100 million in Marine sales added to the 500 million Anchor sales.
So, anyone excited by a holiday shortened, marine sales only week 5 months into a small sales force, controlled, launch is a little to excitable.
Per the FDA guidelines as to when to have these advisory committees
On of the recommendations as to when to have one is below:
-FDA is evaluating a medical product for a significant new indication
That would seem to apply.
However, I agree that most of us were under the impression one would not be needed and the fact one is needed could lead to a more detailed analysis. I just don't think an advisory committee would be necessary. Since the SPA did not require a completed outcome study all that the adcom could analyze is
1) Is it safe for High trig market
2) IS it effective in lowering Trigs
That's it and seems straight forward. Guidelines based on "FDA is evaluating a medical product for a significant new indication" seems the only reason for a panel.
I would think until AMRN submitted for Anchor approval and just now mention this that AMRN was unsure whether this would be necessary but have been notified by FDA it will likely happen.
Did Lovaza get an Adcom when going for High Trig market?
Since Lovaza could never get approval it makes sense the next drug to target would need one.
This is an UNMET MEDICAL NEED in a large population. The result from VascEPA were surprising to AMRN so getting a more detailed look before approving seems logical.
It was publicly stated many times that large AMRN investors expected the stock to drop to $8 if GIA, add to that the NCE delay and the short interest and getting another buck plus lower 6 months after that is not unreasonable.
Seems revisionist history to say Nobody expected a drop like this when it was publicly out there on several websites, on several message boards that if GIA would go to $8.
Once NCE was delayed no chance at BO and then launching in Marine meant no BO since sales would never justify the premium.
Thus we are at the point where a partnership for Anchor that turns into a BO down the road is the play. Some time the next 6 month we should get some news on partnership and then launch Anchor.
Until we see NCE progress or Anchor progress not much reason for WS to start the run up so day traders will play the range and trends but this price area is not unexpected with GIA.
Why do people expect news out of an investors conference, 99% of the time nothing comes out of theses things. Real news is released in press releases not randomly thrown out at conferences.
I didn't listen as busy but based on Stocktwits Joe may expect Adcom in August? Which would mean Adcom would give recommendation on Anchor approval well before December though final say would still be December?
Is that how it works or does Adcom keep opinion private?
Not that Anchor approval, to me, is in question but for bashers could mean we will have something concrete that approval is highly likely well before December?
That is a weird question considering most stock message boards contain longs that believe stock is going up. In this case it is all about Anchor, if they successfully partner and subsequently hit BB status within 2 years then easily 15 and more, if they somehow blow the anchor partnership maybe different story. We will know by end of year most likely
Not a bad week with good increase in renewals which based on teens and previous numbers was expected. Friday before Memorial Day is probably light on scripts, next week will be interesting with it including Memorial Day in this'd numbers, if we ever see a drop that week is possible snd hen July 4 week. Otherwise expect continued uptrend, this is a 40 million a year in sales if they just stayed at this level of scripts so trending up makes a big difference over time
Need to get to 8700 or so to get 100 million per year
All argument easily refuted
Actually, they've done very well to limit dilution. BO before launch was always predicated on NCE decision so there was never going to be a BO or partner before NCE decision. Once Marine launch had to happen they could handle with small sales force for small indication.
Anchor is December, much larger indication and will need to partner.
So..
-dilutive laden...NOPE
-Couldn't land partner or BO..NOPE, based on Anchor so need Anchor launch to determine this
-Marketing muscle-Never intended to market Anchor on own so is not accurate yet either
Bloated market cap: Under Lovaza sale price, Under 10 times Omthera BO price(AMRN has 10 times the market potential) so no there also
All arguments easily refuted......GOLD MINE!
Money, simple as that. If they offer the most money for a partnership and willing to take on more of the expenses for launch tan other partners they can get a deal. I doubt it ends up being them but good to know they are in on the bidding, also good that BP now knows there is at least one other company pursuing AMRN partnership/BO.
But true they do not match up in terms of sales force, combo with own drug etc... so doubt they could maximize AMRN value like other companies but we don't know what is being offered and if Elan puts more in up front and more risk on expenses then it would be an option.
Elan got 3.25 billion from Biogen for sale of Tysabri. It closed on April 2 so cash balance at end Q1 does not include that so they have the money to buy AMRN(with minor amount borrowed) but is more likely in the hunt for the partnership deal which would take less cash as sure ELAN wants to use that cash for multiple options and not just 1. So I would put them in on the partnership. The partnership will eventually lead to a BO IMHO but I believe partnership for Anchor is coming first, then Anchor sales, then BO. Elan has plenty of money to be in on this.
Keep in mind Omthera has a peak sales number of maybe 100 million vs 2 billion Marine, 5 billion Anchor and 20 billion reduce it with Vascepa.
Keep in kind Omthera has poor science compared to Vascepa and will never get Anchor approvel
Keep in mind Anchor is worth worst case scenario 10 times Omthera.
That is totally different than original report that said
"said in a lecture that there is no reason to give Vascepa to patients with triglyceride levels below 500 "
The full text does not say that at all, seems more an answer to a question about Anchor population. The jump to " their opinion that the FDA will not approve " which is not even related to what the person said in this statement.
Seems Summer Street is shorting and using a vague statement to sound worse than reality
Anchor will be approved, these rumors do not seem to come with much analysis. AF and one tiny investment banker with no real history in biotech knowledge.
Anchor met all endpoints, Anchor is not being approved to reduce cardiac events. It's approved to lower Trigs and not raise LDL in the Anchor market, unlike Lovaza which failed to garner that market due to failure in trials. Vascepa has succeeded in all Anchor related trials. I see no evidence they would wait for REDUCE IT when REDUCE IT does not even relate to the Anchor indication. It's a totally separate sNDA unrelated to Anchor.
Anybody got more info on this and who is on the steering committee?
Anchor is not applied to REDUCE cardiac events, it's application is to reduce Trigs. if AMRN was denied then makes no sense for any of the drugs to be approved for High Trigs either. FDA set the protocol and all endpoints were met. Anchor is a no brainer for a drug with no side effects and it's possible 1 member of the steering committee believes that as a small percent of doctors believe they need an outcome study so not too material and there is nothing from the member indicating they think it would be denied.
Seems counter productive for CEo to gear everythign towards Anchor and have a steering committee member say this if true and would like to no the context.
Summer Street says Amarin's Vascepa was downplayed by a company insider at a primary care conference held in Washington DC last week. The firm notes that a member of Amarin’s steering committee said in a lecture that there is no reason to give Vascepa to patients with triglyceride levels below 500 until the outcome trial is complete. Summer Street continues to believe the FDA will not approve Vascepa for triglycerides below 500 until the outcome study is complete.
Teeny bit? it's light years better and the reason they will have Anchor to themselves
The street? Good source, since AMRN has 10 times the market of Omthera seems pretty poor math at the street, would be 4 Billion is the price. Add to that the fact AMRN is pure EPA and thus a better drug, the likely first drug to be given and 4 billion sound low.
So 10 times Omthera price immediately based on potential market size.
The whatever multiple for the fact AMRN works better thoguh we relate that to Marine only so maybe make it worth 5 times Omthers.
Then add the REDUCE IT potential and you are at 6 billion.
So 6 billion based on Omthera sale and actual facts.