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OK, some more realistic (?) idea:
With 27,8M OPEX (R&D - 10,8; SGA - 17,0) and 65% GP% (after KOWA fee) we need weekly 26,1k script ($126 / script) for +/- 0 10-Q result.
I think it could be reached:
- R&D: -8%
- SGA: -17%
It's not easy to predict since Q213 does not contain the breakdown of this two element (maybe at Q2114), so we could not see the trend on these lines.
I know it's not simple, however if we use the script number from last week we get the - mathematical - script number of 21,654 (7408 / 130 x 380) with KOWA.
With weekly +50 script (as average) and at 84% eff. of KOWA team we will reach 26,295 in April 2015. (AMRN team: 10.054, KOWA team: 16,241 - 10.054 / 130 x 250 x 0,84).
I know the PPS does not look good, however it's 'only' the current market sentiment. Usually, bad news is better than no news, but the timing of this exchange was terrible (and not to mention the reason ..) and since KOWA co-promotion announcement nothing happened.
IF Amarin could manage / do their tasks - cost decrease, GP increase, sales increase - we will see a higher PPS and these are up to them only.
ANCHOR approval: who knows? But if they could reach the target above if approved it will be the cream on the cake.
Personally I do not believe the $3/4 range. It will stay under 2 or go over 5/6.
Not dreaming, = joking
Come on man, it's just money ...
I 'hope' it's Renaissance Technologies ...
I think that the ANCHOR SPA itself does not contain any reference for R-IT enrollment, it was about study only.
“Now let me just make a few comments about the special protocol assessment. The goal of this process is for the FDA and a company to come to a written agreement on the design, size, and analyses of studies; use, support, and approval of an efficacy claim. And these agreements are considered binding unless it is determined that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun.”
and FDA set-up the second criteria with the enrollment requirement
“we told the company that they would, at a minimum, have to provide the division with the results from a 12-week lipid endpoint study, and have a cardiovascular outcomes trial up and running with at least 50 percent of the subjects enrolled.”
sNDA with SPA regulated successful study could not be rejected.
Since they did / do not want to approve the ANCHOR indication they HAVE TO rescind the SPA, since Amarin met with all endpoints in the study and R-IT enrollment exceeded the 50%.
I do not say this is the best management in the world, however based on fact and logic (they submitted the sNDA) FDA did not tell them anything before BD. AdCom was about clinical benefit (while Amarin’s indication was w/o clinical benefit), I could not imagine the label wording / offer that allow Amarin to market ANCHOR, since the FDA (Dr. Roberts) clearly said during the AdCom:
'Finally, in order to approve the indication we are discussing today, we need to be confident that the changes in lipids observed in ANCHOR will translate into cardiovascular benefit.'
Currently Amarin have to focus on further cost decrease, cash management and script number since these elements are “100%” controlled by them, meanwhile try to reach a positive outcome from the current appeal level (OND / Dr. Jenkins).
As I stated earlier this level is the most important:
- it’s the originally targeted level
- the upper level will not overturn this decision
The appeal OFFICIALLY at OND level, however it’s absolutely realistic that Dr. Jenkins discuss it w Hamburg (and Hamburg will decide) just like in a normal business where the Director of Department discuss the issue with CEO (or the CEO put to the Director).
btw: Yahoow shows +0.07 AH, however I could not check the volume, since Nasdaq.com 'Service Unavailable' - due to AMRN Volume ??? :)
UPDATE: '16:44 $ 1.37 High 480,800' !!!???
app. -$50M for the first half is correct (06/30 cash will be around $142M) w -$22,5M in Q2 and it equal with -$45M in Q3 and Q4 WITHOUT additional OPEX decrease, increase in GP% and KOWA generated revenue. If these elemnts resulted in $15M we will see the yearly -$80M.
We do not know the speed-up of KOWA, but - just for fun - if we multiply Q2 GP w sales force multiplikator it's +$26M for the second half. (Of course KOWA will not delivery the same script / sales person from D-day.)
But first of all we have to see the next 4-5 script data to see the trend (if any).
at least +$10 or +40-50%, but do not ask the basis since it depends on a lot of other elements (ie.: script trend, ANCHOR approval, etc.)
With the existing R-IT SPA I do not want to see the interim data before March 2016 (967 events, 25% eff. 99% Power / source: Biwatch). We could see earlier if the yearly event rate is higher than 5.2% in the placebo group (who knows) or if Amarin renegotiate the SPA w FDA regarding the time (%) of interim data collection (but in this case we need higher eff., so it's a little bit risky).
It's till theoretical, but based on their cash-flow assumption - -80M in 2014 and will be flat later - they will have enough cash at least till data collection and I assume til the date of publication of interim result which will be - I guess - app. 6 months after data collection (in Q3-Q4 2016).
The Q1 result is good (not excellent yet), but we could see the trend after the Q2 / Q3 result only.
I agree w your appeal process view (w small correction: July- Jenkins / October - Woodcock / January Hamburg).
BB did not said the process OFFICALY reached Hamburg level. He said the case on her desk and for me it's realistic as I wrote "„If Hamburg does not want to deal with this issue, maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, Dr. Jenkins level will be reinstate the SPA by end of July)” and "I guess we will get the final answer from FDA on OND level (if it will be no we have to go through the next 2 level before the court but it will be technical steps only.)" - btw: it' not unusual in the normal business course also
From CC: “We would get a response from Dr. Jenkins and if to that we have a negative response and we have the ability to appeal to next level, which is Janet Woodcock and then up to the Commissioner from there.”
R-IT SPA: it’s not unusual to modify an existing SPA (as I remember the ANCHOR SPA were modified also). and you have right, it could be changed only by mutual agreement and yes I could not think that the design (90% power, 15% efficiency, median 4 years follow-up) could / should be change, ONLY try to set additional (earlier) or new milestone (interim result at x% of events instead of 60%).
Biwatch: please, calculate the requested efficiancy and date with 90% power if the interim analysis will be at (events):
55% - 887
50% - 806
45% - 725
40% - 645
35% - 564
30% - 484
At 522 events (32,38%) with 90% power we need 25% and it will be in 11/2014 (Biwatch, 27152)
I think that this is the only one which - maybe - could be negotiated with the FDA and assuming that with 90% power R-IT will be stopped.
I agree: "Do not expect the FDA to change their position on the study being powered 90%"
Data collection will be in 01/2016-07/2016 (15-50%) and IF they will release the number of event in placebo and Vascepa group we could calculate the exact efficiency, BUT the final result (after analysis) will be released during 07-12/2016 (I guess the analysis will take 6 months at least). As Biwatch wrote on seekingalpha, if V is at least 25% effective (Power: 99%) R-IT will be stoped.
Regarding financial: Currently I expect the break even in Q22015, however too many unknown conditions are exist (script trend is temporary or constant, KOWA effect, OPEX decrease rate, etc.). I will update my model after any new relevant info and I guess we will have more exact picture after the Q2 10-Q (and after the OND's decision)
Under the current SPA we have to go till 1,612, but interim analysis will be done at 967.
Yes: 5,2% is per year
Yes: if V better than 15% it will take longer to get to the 60 percent milestone of 967.
(I am not sure, but think) we could stop the study based on interim result if the power is at least 90% (V better at least by 19%).
Biwatch calculated scenario in posts 21684 and 27152. (But that scenario based on power & efficiency and not on number of events).
We could get / check interim data earlier than 01/2016 if Amarin renegotiate the SPA with FDA.
Expected total events is 1,612 - with 5,2% event rate in placebo and 15% efficiency -, however interim analysis will be done at 60% - 967 events.
967 events will be at:
https://drive.google.com/file/d/0B88p2VqeOjMGZGFSc1VoMVJCSTg/edit?usp=sharing
columns: event rate
rows: efficiency
Unfortunately I could not calculate (yet) the Power for each case.
As I interpreted BioB statement: Legally / officially is at OND level, however Hamburg will decide it. see my post #27776
I think it useless to evaluate the agreement now, however the timing is not unintelligible:
“As previously described, our goal is to achieve net cash outflow of not more than $80 million in 2014 and to make our cash flat.”
“The Kowa team should be before the end of this month be fully trained out and promoting Vascepa. They will have the advantage in getting started that they already have relationships with customers.”
„ …submitting a round of appeal in the next line of review with FDA, which is John Jenkins the head of the Office of New Drugs. And then we'll probably end up meeting with him 30 days after we submit. And then after that, he should get back to us within another 30 days. So given where we are in this and how long it takes to go through the process and delays that have occurred thus far and as part of that process, our plan is to provide updates on at least a quarterly basis, but unless there's a significant change in status we probably just update on the quarterly call.”
Why it was necessary now and not in August /September, when we will have some idea about KOWA effect and we will know the OND’s decision.
I am not surprised. As I wrote in #27382: „If Hamburg does not want to deal with this issue, maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, Dr. Jenkins level will be reinstate the SPA by end of July)”.
ggwpg - Amarin did not lied: officially it is OND level, but technically it will decided by Hamburg (/Woodcock).
louieblouie - the question is not "is it true or not?" but "is it logical or not?"
Maybe I am wrong on reinstatement, but based on your info I guess we will get the final answer from FDA on OND level (if it will be no we have to go through the next 2 level before the court but it will be technical steps only.)
Call me optimistic, but I think the background of the appeal is strong enough for a “green lamp” from Hamburg, resulted in a positive decision from OND level and after that the sNDA will be approved (for =200 mg/dL and <500 mg/dL population with compromised label.)
pros:
- the drug is safety and effective
- the study was 100% according to the SPA
- OND level is the originally targeted level (not a surprise, since the previous two played an active role in recession of SPA)
- (I guess) the next two level does not want to deal with this appeal officially (let’s say they do not want to overturn the previous levels’ decision and they do not want to go to court.)
cons:
- negative AdCom vote, however they voted on Reduce-It
- new science, however the background is not the strongest (especially as the population in the 3 citied study were different and the sub-group data did not confirm the “new” science)
(ps.: I never requested a proof from anybody, but I always analyse the logic of the statement)
I think we could really evaluate this more precisely in August (only 3 months ahead...). The main issue with this deal is not the exchange rate increase, but the exchange is the holder's decision now while it was the Company's under 2012 Notes term. This could be the big issue for us as shareholders.
It's a little bit ironic, but we have to hope that this step was a really bad one, because if not we will be below $2.86 by the end of 2016.
I am still not understand why we could not wait to see the first 1/2/3 months of KOWA effect and receive the decision of OND / Dr. Jenkins. (and btw: do not forget that they announced it 4 business day after the 10-Q / CC ...)
Director of OND (Office of New Drug). The curent appeal level.
One small, but easy market for Amarin /KOWA: Hungary, where Omacor is an OTC product.
We all hope. Horizon's sales force:
"As a result of the acquisition of the U.S. rights to Vimovo, Horizon began the expansion of its sales force to approximately 250 primary care representatives and 40 rheumatology sales specialists. The company completed the hiring and training of the expanded sales force in January 2014 and began full promotion of Vimovo in early February 2014."
Hopefully KOWA's rep will be effective at least the same level
First of all I never take anything as personal and I –try – to not insult anybody else. I never comment post of ricardoga, Dawid Fowler, New Money, etc, since they do not say anything. (btw: it’s so funny that some of them is the moderator of this board …) I try to fit Ajax’s statement to the fact – and I could not – but it was not about Ajax, it was about his statement. Since, I have a finance, company operation background I couldn’t not to comment if somebody asking “stupid” question, requesting info that is not for public.
I am still believe that - with KOWA - Amarin could generate a decent revenue (w/o ANCHOR). Management said during the last CC “As previously described, our goal is to achieve net cash outflow of not more than $80 million in 2014 and to make our cash flat.” and I think it’s doable.
My problem with current step is:
- benefit – if any - is significantly lower than advantage
- it was not necessary now (or if yes we were definitely misleaded)
- so, it’s not fit to the communication of the Company
- it has a long term effect (any result will be worth 85% only in the future. We do not know the exact condition for the exchange, but if we receive a BO offer - let’s say – $15, the holder will convert and we will receive $12,75 / s)
Without a good reason – and if any, that is bad for the shareholders – this step is unacceptable in May, 2014.
I am so interested what will be the opinion of “supporter of this action” if we will hit 50M revenue in Q414 (I do not believe, but who knows)… and if I am wrong and it will be really important in 2017, than …. AMARIN (R.I.P. – 2016)
I am still belive in the drog and I think / thought that the near future (Q2-Q3)2014 will be better, however this action is scarying me. More than the FDA decision. Quote from mrmainstreet on YMB: "tw Mike in IR and he explained the PR. simple debt restructuring to push back possible repayments until 2019."
I could not imagine a scenario with (80)M in 2014 and later a flat cash-flow and a problem to repay the remainimg debt - that sholuld be less than 150M - and IF the holder want it, in 2017.
But let say ok, give more shares if it converted, HOWEVER it was a decision of the company under 2012 note and it's the holder's choice from now.
Yes, however it's more then blunder ... I still do not see any valid reason for this (now). I do not want repeat myself, but the timing (4 bdays after CC), "benefit" (rescheduling 2 years later) vs disadvantage, communication - are not understandable for me. Why now, why not x months later. I guess it was initiated by the Company, so what's the REAL reason behind this?
Delay 2017 obligation in May 2014? Before KOWA effect? With 80M cash-flow in 2014 and a hope/promise that cash-flow will be flat?
How could be in a position to made this decision, now?
If they could not pay that 32,2M in 01/2007 and they already know it then then they could not pay it in 2019 since it will be closed already.
If they issue the same amont of share - 32,2M - for $1 PPS anytime before 2017 they could pay the remaining obligation.
For me this step is not in line with their communication and what is necessary BEFORE end of 2016.
And they really could not know it on last Friday? "Funny" to see this event 4 business days after the CC ...
It's true, but it's 2017 & 2018. According to 10-Q by the end of 2016 the remaining BioPharma Repayment—Principal & Interest will be 38,1M and it could not be a problem that time (?)
The 2 years change (2017 to 2019) is not worth additional 32,2M ADR.
Yes, but what's the reason behind this? They did not get additional fund. So what is the benefit for the Company? Why they accept to change the existing condition for worse?
It' good for the stockholder only (as I see).
btw: it's 4 business day after the CC and they did not mention it at all. I do not think it was finalized during the last 4 bdays.
Without full theory (do not want to speculéate): I think the number of shares is important in case of exchange ...
Correction (I converted the full 2012 into 2014, while the conversation is 118.734 million “only”)
It’s more than interesting, it’s strange. At first sight it’s so good for the holder. What is the reason behind this? My view that the new conditions are worse. Why the Company (have to) did it?
Key changes (2012) 2014 conditions
The 2014 Notes will be exchangeable into American Depositary Shares of Amarin ("ADSs") at the option of the (Company) holders at an initial exchange rate of (113.4752) 384.6154 ADSs per $1,000 principal amount of 2014 Notes (equivalent to an initial exchange price of approximately ($8.81) $2.60 per ADS), subject to adjustment in certain circumstances.
Reworded of 10-Q:
If the (Company) holder elected physical settlement, the Notes would initially be exchangeable into (17,021,280) 49,214,841 ADSs. Based on the closing price of the Company’s stock at March 31, 2014, the principal amount of the Notes would exceed the value of the shares if converted on that date by ($119.2) $60.9 million.
Conclusion: they have to give more ADR (+32,2 M) and the exchange depends on holder instead of the Company. The holder decreased the average price to $3.05 from $8.81.
It’s more than interesting, it’s strange. At first sight it’s so good for the holder. What is the reason behind this? My view that the new conditions are worse. Why the Company (have to) did it?
Key changes (2012 conditions)
The 2014 Notes will be exchangeable into American Depositary Shares of Amarin ("ADSs") at the option of the (Company) holders at an initial exchange rate of (113.4752) 384.6154 ADSs per $1,000 principal amount of 2014 Notes (equivalent to an initial exchange price of approximately ($8.81) $2.60 per ADS), subject to adjustment in certain circumstances.
Reworded of 10-Q :
If the (Company) holder elected physical settlement, the Notes would initially be exchangeable into (17,021,280) 57,692,310 ADSs. Based on the closing price of the Company’s stock at March 31, 2014, the principal amount of the Notes would exceed the value of the shares if converted on that date by ($119.2) $45.6 million.
Conclusion: they have to give more ADR (+40,7 M) and the exchange will be the holder's choice instead of the Company.
Interim data collection / analysis is based on number of events. The current expected date (earliest is 01/2016) is already "speculative". iHUB #27575
#21684 and #27152 is possible IF the FDA agree to change the current R-IT SPA ...
Agree, however based on current SPA (interim will be at 60% of 1,612 events) and enrollment data the expceted date for 967 events (data collection):
- 15% efficacy: 01/2016
- 50% efficacy: 07/2016
+ (I think) at least 3 months to analyse/release the result. So, 04/2016 as earliest.
We could see earlier result if the event rate is higher than the expected 5,2%.
10-Q 032014
On December 30, 2013, the Company issued a notice of termination of its API agreement to BASF as a result of BASF’s non-compliance with the terms of such agreement. BASF did not remedy within a contractual 60-day cure period and as a result, this agreement terminated on February 28, 2014.
Land of finance, company management, acquisition, merger, business development, financial report, etc. ...
Yes, I saw several times ... Do you have any idea about company valution?
Do you know the difference between shareholder and owner? But shortly: Please, provide a link any detailed forecast (GL) for 2014 of AZN or GSK or PFE ... and do your homework and try to find out (with assumption and scenario) how they could reach less than 80M cash-outflow.
You have right we could not judge on Ajax credibility, maybe he got false information from his source. It’s not help if we talking about the credibility of anybody instead to analyze his statement.
My “problem” with the current statement ( FDA put back the SPA on the table and was open to approve =200 mg/dL and <500 mg/dL with warning label, but Amarin rejected it:
a.) How could they modify the SPA after the end of study? Why is it SPA and not sNDA? (PDUFA and approval is of sNDA and not of SPA.
b.) Amarin said several times that in their indication - Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent – it was only a target population and they are running Reduce-It for the proof. So, never mind how you interpret the original wording – let’s say reduce CVE, FDA:” “Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment.” – I do not see a reason why Amarin refused the offer which equal with their interpretation of the indication – no CVE
c.) On the other hand FDA said that the only reason to treat these mid-range triglycerides is to prevent heart attack, stroke, and death. “ … companies wanting to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease” and made the mentioned offer to Amarin … (?)
It looks like all party did the opposite what they said .. FDA would like to approve without proof, Amarin did not accept their targeted indication.
It’s not logical for me.
And finally, yes: currently the top priorities are increase revenue / script and decrease cost since this two elements only which 100% depends on Amarin. For all other – appeal, legal case, etc. – they need at least one other party involved.
I do not need proof, just let me know what was the offer. IMO: Amarin did not apply for CVE reduction.
btw: why the SPA was on the table and not sNDA? How could they modify the SPA after the end of the study? PDUFA is about sNDA and not SPA.
It's the target population only, however if your interpretation is correct, they have to delete high triglycerides (=200 mg/dL and <500 mg/dL) also, since according to FDA: the only reason to treat these mid-range triglycerides is to prevent heart attack, stroke, and death. “ … companies wanting to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease”...
We are at the first "real" level, since previous level (ODE II) was Dr. Coleman. I do not have to introduce him to anybody on this board ...
Lovaza was rejected for "ANCHOR" indication based on study result, however the official, FDA approved label contains "14.2 Other Clinical Experience" details the faild study. So it is not a compromise for Vascepa.