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And the IPs are owned by AMRN (not by Pharmakon)
Vascepa + statin will be substantially more efficacious than mineral oil + a statin.
Re the combined drugs you cite as being 575k. You have got to add statins to the list
My post was re your MARINE only (stop R-IT) idea. “From a purely fiscal perspective, it would make far more sense to scrap the trial, preserve that cash, and spend the money on hiring more reps for the MARINE indication.” and as I wrote it is not an option. R-IT is the only one.
Favourable interim data could result in the trial could be halted for efficacy/safety concerns in the placebo arm by the end of next year.
You quoted a figure of $200M "for simplicity". For starters that figure is way too high.
How many sales reps did GSK have when they were pulling in $1B/year? What was their script count/week? Had to have been at least 100k.
Your "R-IT market" calculations appear way off as well. ….
Vascepa WILL NOT be prescribed alone
The commitment to R-IT is for BP's benefit, no-one elses. If this drug is to have a future it will be in BP's hands.
Commitment to the R-IT does not mean anything, other than they do not have a choice.
From a purely fiscal perspective:
- it had not been an option to stop R-IT ever
- R-IT is not for FDA’s favor, it’s for AMRN’s favor
MARINE market only (with current expenditures w/o R-IT cost):
- breakeven is around 20k scripts / week
- if every patient who takes V / L / generic L (85k) takes V: $5M weekly, $260M yearly profit
- PPS (for simplicity with P/E:1 and 200M shares): $1,3
R-IT market (with current expenditures w incremental $253M Selling and Marketing expenditure and w/o R-IT cost, since it was finished):
- breakeven is around 83k scripts / week
- if every patient who takes V / L / generic L / Fenofibrates / Niaspan / Tricor / Trilipix (575k) takes V: $38,5M weekly, $2,000M yearly profit
- PPS (for simplicity with P/E:1 and 200M shares): $10
To finish R-T they need (for simplicity) 200M. If they raise it as a dilution (I do not think it, but assume with $1/shares) it is additional 200M shares:
- PPS (for simplicity with P/E:1 and 400M shares): $5
Hm? $1,3 vs $5? I think it is not a question.
Hi Kiwi,
AMRN vs AZN
Issue: '662 patent. The patent require that treatment not "increase[e] LDL-C by more than 20%"
AZN argument #1: The commercial launch of Epanova has not occured and is not imminent and "real life" LDL-C data could be different than during the study ... no comment ...
AZN argument #2: Epanova label fall outside the claimed range based on non-placebo adjusted data (2g - 21%, 4g - 26%) - BS. The patent makes clear that the measurement of LDL-C in a patient as claimed in the patient is against a baseline (non-placebo adjusted data) or a placebo arm. Epanova, against the placebo arm: 2g - 13%, 4g - 15%.
Best,
G
Technically everything is still possible:
- ANCHOR approval
- CRL with recommended action:
a.) modified indication and / or
b.) ANCHOR data on label or
c.) accelerated sNDA submission
- CRL w/o short-term solution (complete R-IT)
Meanwhile, no deadline for the sNDA I do not think that FDA will wait till R-IT result. I think (hope) they will act within the next 6 months.
Until FDA's action AMRN has to playing nice.
BioC & JL & Kiwi,
Some thoughts:
I do not know any business which collect ALL data. TV ratings, sales data, etc. are always based on the x% of the universe and extrapolated by statistical method. (As I remember IMS collects app. 70% of the data.)
The exact sales data (by doctor) is not available, otherwise why KOWA is entitled for the x% of the total GM and not based on their sales ...
However it is interesting on a weekly basis only, since we could calculate the exact (+/- 5-6 script due to report in kUSD) number of scripts on a quarterly basis.
Meanwhile the data are exist (as wrote by BioC) it was not - and I guess never will be - collected into one database.
But let say, yes. "We" will know that by who, to whom and how many V was prescribed, however no info about indication / aim of usage. (I never saw a US script, but I assume that as in Hungary the script itself does not contain the indication.) - my conclusion: AMRN could not partner with other company for other indication, since the revenue could not be (exactly) breakdown by usage.
The yearly Selling cost (inc. marketing) is around 60M. They need app. 15k scripts / week for Selling breakeven (w/o KOWA fee and Pharmakon payment).
Not really. They always booked the delivered value, just broke down to actual and deferred revenue (based on calculation). On a long term no difference between the new and old method, just on a quarterly basis.
I guess the main reason was to avoid revenue decline in Q12014, since if they continue the old method (defer part of the revenue) the Q114 should be less than Q413.
I was how said "You could not breakdown script# / revenue by indication / usage." I mean it is not possible to collect royalty from / share revenue with other company for (ie.) DES indication.
Simple example: we do not know (and I guess AMRN do not know also) on and off-label script / revenue breakdown.
even an accurate count on weekly scripts
1.) they have to do it without dilution, since dilution is not an option at this pps
2.) Good point. I do not expect more than 2M decrease in OPEX (Q2: 32.821), but increased GM% (to 62 from 60,14%)
3.) We do not see the breakdown of SGA, however based on previous CC, GA is less than 15M / year. Q2: GM was 7,6M vs S (inc. marketing) 15,7M
4.) We won't see any exact update.
I guess we could defend the patent(s).
I bookmarked it, but was too busy.
I will answer your questions, but please note that you could not valuate AMRN based on current P&L, BS and CF since the biggest part of the value is the future (R-IT).
EXCHANGEABLE SENIOR NOTES: It's minus and the value is $150M (The diff. is booked on other lines as accounting technique.
OPTIONS, WARRANTS: The value is plus, however it's a "dilution" by the number of shares
RESTRICTED STOCK UNITS: It's a "dilution"
TAX LOSS CARRYFORWARDS: The latest, exact info is from 10-K 2013:
"The Company has combined Irish, UK, and Israeli net operating loss carryforwards of $528.2 million, which do not expire. In addition, the Company has available U.S. Federal tax credit carryforwards of $4.1 million and state tax credit carryforwards of $1.8 million. These carryforwards, which will expire starting between 2029 and 2032 may be used to offset future taxable income, if any. The Company recognized a tax benefit related to the extension of 2012 research and development credits into 2013 and recorded a discrete benefit of approximately $1.9 million."
and they generated additional loss in 2014. Furthermore, loss carryforward is not equal with "tax base decrease". ie.: depreciation acc. to tax law decrease the base, but the booked depr. increase the base (the tax and accounting depreciation rate do not have to be the same).
You could not breakdown script# / revenue by indication / usage.
Do not take it personally: It looks like people "with number", specially with 3 at the end - do not like the management ...
I do not think dilution is coming. And definitely not at this level. A lot of option is available. Just one example: more loan from Pharmakon.
AMRN has to act by end of Q2 / beginning of Q3 2015, if no significant increase in script. Until that a lot of thing could happen to support the pps:
- NCE: I am optimistic based on previous cases (moiety vs ingredient)
- AZN patent case: I am also optimistic, since AZN main argument is - Epanova not on the market. They are not challenging the patent itself (forget that stupid active arm argument)
- CRL: I am not optimistic, but it could be "positive" (ie.: suggest accelerated submission, data on label)
You saw correctly. By 15/12/31, 45%, P / V - 547 / 301
With zero increase in script# they have enough cash till end of Q12016. (Of course they have to raise earlier).
I guess, divergence - between V and P arm - is not enough analysis is required and it takes 3-6 months. (Otherwise why they have a predefined interim event number - ergo, quarterly review is not enough)
Small correction:
also to the Corsica group
"The shelf is active." by AMRN's IR, 2014.09.04.
Placebo.
"Please be advised that 5.2% is the anticipated placebo event rate." by AMRN's IR
The time scale major unit is 15 days.
"Full" enrollment (7900): 2015.04.02.
period / 15% / 25% / 45% / placebo (event numbers for the period)
2014.10.06.-21. / 6,67 / 5,88 / 4,31 / 7,85
2015.04.04.-19. / 7,17 / 6,33 / 4,64 / 8,44
So it was included.
If you could provide the exact eff% for every quarter I will draw a non-linear. Until that, everybody could draw a linear only (assuming the same eff.% for every period)
Except combo pill, it's "not possible", since they could not separate the scripts by indication.
Something like this?
https://drive.google.com/file/d/0B88p2VqeOjMGUXdLdGxaLWY1NFE/view?pli=1
60%, 967 events:
15-25%: Nov - Dec, 2015
26-35%: Jan - Feb, 2016
36-45%: Mar - May, 2016
46-55%: May - Jul, 2016
Mel Gibson in "Conspiracy Theory" was a beginner compared with some of you. Meanwhile I am long, it is so "funny" to see that a lot of people think that AMRN is the "center of the world" ...
I agree with the author, they have to decide it by end of Q22015. At that time:
- they could estimate the interim look date with "+/- one week"
- 1 year KOWA experience
and maybe
- positive NCE decision by the court
- ruling on AZN's case
Placebo - V event rate:
4.81 - 4.81
5.20 - 4.42
5.59 - 4.02
generate exactly the same event#, meanwhile the eff% is 0 - 15 - 28%. How they could conclude anything? Top of that the overall event# is as expected.
5,2% is the expected placebo rate, however they have access to the total event# only, so it could mean several thing. Just for example: lower placebo rate, but higher V or higher placebo and lower (more effective) V or 5,2% placebo and V eff.% is 15%.
I do not know the exact event#. I am calculating the event number. We know that the expected placebo rate is 5.2% / year. As of today placebo arm: 306 events. If V eff. is x% than the V arm event is (total):
15% - 261 (567)
20% - 245 (552)
25% - 230 (536)
30% - 215 (521) - power is 90%+
35% - 199 (506) - power is 90%+
40% - 184 (490) - power is 90%+
I could not calculate the power but Biwatch helped me earlier and we know that for 90% power, we need at least x% eff. at y% (number) of events:
15% / 100% (1,612)
19% / 60% (967)
20% / 55% (887)
20.75% / 50% (806)
22% / 45% (725)
23% / 40% (645)
24.25% / 35% (564)
26% / 30% (484)
Yes, it contains some "extra" due to "under-reporting" (mistake of weekly script calculation by IMS / Symphony), but it is under 10k - 9,434 -, since 1 Q is 13 wks.
Basically I agree with most of his opinion. Few comments:
- he was conservative reg. script# and GM%
- AMRN does not have to be CF positive to reach interim analysis (early stop of R-IT)
I am also so interested in the upcoming 10-Q, since the CF was extremely good in Q3.
My expectation:
Scripts: 122,644
Rev: 15,907
COGS: 6,045
GM: 9,862
OPEX: 30,254 (w/o non-cash items)
Operating I/L: (20,392)
JL,
We agree:
- Amarin does not have to proof of CVE efficacy in ANCHOR
- FDA reason is not the strongest
- no ruling before mid-2016 (as earliest)
We do not agree (we do not have to and looks like won’t):
Meaning of SPA (including R-IT condition):
JL: award the sNDA
HDG: submission of sNDA
What is required for rescission?
JL: new (substantial?) scientific issue / evidence
HDG: determine that available info / evidence is not enough, substantial scientific issue essential to determining the efficacy
It was a breach or not, legal or illegal? – it relates to the previous one
FDA deliberately withheld information:
JL: It was to ensure Amarin would be committed to going forward with an expensive outcomes trial and FDA could release ^share the new approach earlier
HDG: FDA analyzed the situation due to sNDA submission and rescinded the SPA within 8 months.
Reason for suing:
JL: Reinstatement of SPA and claim damages
HDG: Reinstatement of SPA. (I guess to claim any damages should be a separate case and the result will be more questionable than the SPA case)
R-IT:
JL: AMRN runs the trial since it was required by FDA (part of the ANCHOR’s SPA)
HDG: AMRN runs the trial to proof V’s efficacy. (They planned the trial before ANCHOR’s SPA)
Meanwhile this summary is a “B & W comparison” a lot of area is grey (ie: timing of rescission). I think our view together is good to see the best and worst case together. (I think we won’t get the answer since AMRN will not go further with the appeal.)
JL,
I know that my grammar is not first class, but no problem to understand. Yes, I misunderstood the FDA’s appeal, however due to logic: what type of money should be recovered by FDA? Do you think that ruling on SPA will penalize FDA for business losses of AMRN?
Based on your post, we could agree (?) that – best case scenario, shortest duration – the first ruling will be around mid-2016. What could be gained by AMRN at this time? If you have right R-IT already stopped in 2015 or we are in / after interim analysis. I could not see any benefit to continue the appeal, go to court. I do not think it worth any cent or any second.
The FDA director "determines"...thats just BS.. The FDA can not just make something up to get out of the agreement.
Please understand if I accept your time lines and your conclusions, then I would be compelled to agree with you.
The FDA's exception (right to abort) was based on new substantial issues re safety of efficacy.
The appeal process is to get the money back..
JL,
The first point of view is not the cost of appeal. Is it meaningful or not? What (and when) could be gained?
What? – Reinstate the SPA. Chance: max. 50%
Timing: FDA rescinded the SPA within 8 months after sNDA submission
Reason of rescission: Not enough evidence about efficacy
AdCom: "Do you believe (true or false) Vascepa’s beneficial effects on the studied lipid/lipoprotein parameters (ANCHOR) are sufficient enough to grant approval for co-administration with statin therapy for treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?" - "Do you believe beneficial effects on surrogate endpoints are sufficient enough to grant approval for co-administration with statin therapy for treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent without outcome study? Do we have approve something based on unvalidated surrogate endpoints?"
When? – At least 1 round of court, however it’s 99,9% sure that if necessary FDA will appeal, so we could calculate with at least 2 rounds.
The case could be filed in Q2/Q3 2015 as the earliest and the District Court phase could take 2 years (as usual) – first ruling mid-2017. If the ruling in favor of AMRN, FDA will appeal and it will take additional 1-2 years.
Result:
1.) No reinstatement – Useless action
2.) Reinstatement of SPA in 2019 – Useless action
For a good business decision you have to check all possible scenario, not the positive(s) only. All of your scenario (1-3) are possible, however if none of them exist, it is still useless, not important option to continue the appeal: they could not gain anything
It's fifth, fourth was mine
NCE also gives Amarin new avenues of PDUFA appeals according to Regulations.
Fourth: waste of money
Does not expect different decision within FDA. Court: the result more than questionable, definitely not a slum drunk. The first ruling won't be before 2017 and the final (after 1 or 2 appeal) won't be before 2019 ...
That was a theoretical example only, not an exact case.
The requested data:
4000 were enrolled in Feb 2013 (sNDA submission)
median follow-up of 6 months: mid May 2013 (enrollment was around 4950)
Of course, no problem. Since the case will be ended after the interim analysis I would afford to take anything on contingency ...