Do you know how many triglyceride killers have been blockbusters?
From 2010 to now, they are Tricor, Trilipix, Niaspan and Lovaza. But no one of them can lower LDL, and no one of them can prevent heart diseases.
Conservatively, 2Q Revenue will top $9M (analysts estimate is $8.34M currently). Any increasing income will push the "cash drought" bashing to be remote away.
No ANDA can be filed without a clarification of the exclusivity status from FDA.
Scenario A: Three year exclusivity, upon MARIN NDA, be granted (ending 7/25/2015) later -- ANDA can be filed, thereafter, with a paragraph IV certification triggering a 30 month stay. The patent case will go to a court -- taking years for the verdict.
Scenario B: NCE, upon MARIN NDA, be granted (ending 7/25/2017) later -- ANDA can be filed after 7/25/2016, with a paragraph IV certification triggering a 30 month stay. The patent case will go to a court -- taking years for the verdict.
Scenario C: NCE, upon ANCHOR sNDA, be granted (ending 5 years from the approval of the sNDA) later -- ANDA can be filed after 4 years from the approval, with a paragraph IV certification triggering a 30 month stay. The patent case will go to a court -- taking years for the verdict.
Scenario D: ......
It is not due to the clown himself. A clown is a clown, is a clown, ... and is a clown. Right?
It is due to the Hedges behind him. Adumb Foolstein writes, often, whatever the Hedges want. And Hedges can control a weak stock easily. Thus, some of AF's articles reveal Hedges' plan. Reading AF from his back may be helpful for planning the next step.
Hedges are, usually, beaten by strong stocks. With Vascepa's growth, AMRN is in progressing to be a strong stock. I believe AF will change his tune soon, when Hedges give this one up.
BTW, Vascepa keep enjoying exclusivity (good for growth) without any exclusivity status.
How about FDA keep indecision on the NCE till REDUCE-IT approval/denial (everybody will have a clear view in a few years later)?
Actually, it is a good news to Amarin for now. Without the clarification of the exclusivity status, FDA would not accept any ANDA application (btw, with NCE granted FDA will accept ANDA application with the paragraph IV certification at NCE+1 -- 1 year before the NCE expiration date). I.e., before the clarification of the exclusivity issue, vascepa enjoy exclusivity without any status.
You didn't touch the specifications of mixtures. Say Lovaza vs. Vascepa, both are consistent of EPA and DHA but in different proportion. If your narrow definition stands, then only the first approved mixture of EPA and DHA, i.e., Lovaza, is eligible to NCE. Then FDA should make up their mind in July 2012.
The issue here is that mixtures consisting of the same factors but in different proportions could treat different diseases. E.g., Lovaza for triglyceride disorder, Vascepa for heart health. NCE with mixtures is a new subject for FDA -- that is the reason for why taking such a long time without a decision. And, from my view, different therapeutic applications (need to be clearly defined, particularly in significances) would be the KEY.
Treating high triglyceride can be termed as treating triglyceride disorder. And the disorder could be level I ( 200 gm/dL) or Level II ( 500 gm/dL).
Treating high LDL, can be, similarly, termed as treating LDL disorder.
NCE stands for New Chemical Entity.
However, for a product based on fish oil, it is a mixture of EPA and DHA. The proportions of the factors in the mixture can be changed in to a different mixture. So, whether a fish-oil-based mixture can be an NCE is fuzzy.
Based on my experience, I think FDA should make the distinction in a therapeutic standard. Lovaza had its NCE status by GSK's clinical trials of proving its significant benefits therapeutically (against placebo). Vascepa's MARIN also showed the benefits, and some results (lowering LDL etc) was significantly improving from Lovaza, but its treatment indication is the same as Lovaza's.
At lease, ANCHOR provides a significantly improved indication. Thus ANCHOR has much higher potential to have an NCE than MARIN (I still think that MARIN has some chance to have an NCE based on lowering LDL).
Let me try to answer your concerns.
The cost, per RX, is about $120 monthly.
Lovaza's 420,000 and 382,00 monthly are just indifferent.
In consideration of V's low scrip (running at about 17,000 monthly) currently, I believe that many potential takers are waiting for Tier 2 getting thro (a few months later) to pay $25 monthly. Anyway, V is for improving health, not for treating life-threatening diseases. So, no hurry.
Month Lovaza Vascepa
Jan/13 419,518 333
Feb/13 406,731 2,853
Mar/13 382,405 6,491
Apr/13 426,915 10,695
May/13 420,018 14,545
Lovaza's TRX peaked, 103,464, in Dec, 2012 (launched in 2005).
Obviously, Vascepa is in an exponentially growth phase and Lovaza is flat toward a noise-diving.
V's market share are just in the exponential phase. Need 3-5 years to reach the peak. With MARIN only, the peak TRX would be around 100,000 weekly. Adding ANCHOR, the peak would be about 300,000 weekly. RUDUCE-IT could achieve 1M weekly (i.e., about 1% American on V).
A long way to go.
Friday is June OPEX.
The maximum pain is at $7: currently 11,506 Calls and 6,830 Puts. The 6,200 contracts of $7 calls purchased today were at about $0.30 per share.
If Calls are strong enough, Friday's close would be above $7.30. Otherwise, the close would be at $6.99.
Seemingly, we may miss the Sunday's Scrip Number.
Previous experience tells me that whenever the Scrip becoming critical to trading Big Boys would cut off the resources of leaking.
Currently, the short-side is in charge of trading. So, the reading of lacking scrip numbers may indicates the numbers aren't in short-side's favor. Anyway, we may know the number tomorrow.
The buyers of those PUTs are AF's followers. They suppose that ANCHOR will fail to gain AdCom's endorsement in August, and will fail to gain approval in December. However, the AdCom meeting about Vascepa has not been scheduled yet ("August" was AF's assuming). BTW, yesterday's AdCom meeting about Avandia showed that Dr. Nissen was in the minority champ (they are still frozen under the Vioox shadow).
Without ANCHOR approval, weekly Rx could go up to 100,000 (off-label included); with ANCHOR approved, it could go up to 300,000 (off-label included). With REDUCE-IT approved, weekly Rx could go up to 1M.
The prediction surprised myself, particularly the revenue. However, now is Jun 2nd, thus the extrapolation is only going further for one month. Based on five months stable data to predict one more month, it should be reliable
The analysts estimated revenue is $8.34M. I expect that they will update their revenue-estimate soon.
Mar_____6491_____7260 (1Q 10854)
Jun(E)__27992____30791 (2QE 61804)