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I could not ... since I sold mid-April (@6.49) and did not buy back ... instead bought EVFM (@4.84) and sold after approval (@7.50).
Best,
G
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e.g.:
Atrial Fibrillation/Flutter
Icosapent ethyl is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
Bleeding
Icosapent ethyl is associated with an increased risk of bleeding. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.
Best,
G
c-
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34,496,685 as of March 31:
- 5.564.939*: owned common and tradable anytime
- 28,931,746**: it is a common equivalent of owned Series A Preference Shares ... but it was not owned as common, was not tradable
34,496,685 as of June 30:
- 29,336,307: owned common and tradable anytime (5.564.939 + 23,771,368 converted from Series A in April)
- 5,160,378**: it is a common equivalent of owned Series A Preference Shares ... but it was not owned as common, was not tradable
* most of it - if not all - are the result of Note(s) conversation and exercise of (open market) options, are not open market purchase
** owned as Series A (Series A number: 10x the numbers above)
Best,
G
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Amarin sold 352,150,790 Series A Convertible Preference Shares in March 2015 to
- Baker Brothers Life Sciences, L.P.: 267,921,860.00
- 667, L.P.: 21,395,600.00
- Stonepine Capital, LP: 37,500,000.00
- Broadfin Healthcare Master Fund: 25,333,330.00
(Please note: 667, L.P. is a BB Co., so BB got 289,317,460 ... Stonepine and Broadfin got 62,833,330).
During the three months ended June 30, 2015, 62,833,330 preferred shares were converted, resulting in the issuance of 6,283,333 ordinary shares. I think it was Stonepine Capital, LP and Broadfin Healthcare Master Fund. 289,317,460 Series A Convertible Preferred Stock was issued and outstanding as of June 30, 2015 ... exactly the same as bought by BB.
In July 2015, Amarin completed an additional sale of 38,867,180 Series A Preference Shares to Sofinnova Venture Partners VII, L.P. (Please note: Sofinova has a right of first refusal to purchase up to 9.94% of an offering by the Company of its ordinary shares or any securities exercisable into ordinary shares [based on October 12, 2009 Securities Purchase Agreement]). 328,184,640 Series A Convertible Preferred Stock was issued and outstanding as of September 30, 2015 ... exactly the same as bought by BB & Sofinova.
During the three months ended September 30, 2018, the Company issued 3,886,718 ADSs upon consolidation and redesignation of 38,867,180 Series A Preference Shares. ... exactly the same as bought by Sofinova. 289,317,460 Series A Convertible Preferred Stock was issued and outstanding as of September 30, 2018 ... exactly the same as bought by BB.
HOWEVER
I admit I was wrong when I said / thought that Baker Brothers "sold 23,771,368 in Q2".
I thought BB owned 34,496,685 ADSs (each representing one Ordinary Share) as of March 31, TOP OF the Series A Preference Shares ... but they did not.
The 34,496,685 includes:
- 5.564.939 ADSs
AND
- 28,931,746 ADS that may be acquired upon the conversion of the Series A Preference Shares.
As 237,713,680 preferred shares were converted, resulting in the issuance of 23,771,368 ordinary shares in April 2020, as of June 30, 2020, BB owned 34,496,685 as:
- 29,336,307 ADSs and
- 5,160,378 ADS that may be acquired upon the conversion of the Series A Preference Shares.
Best,
G
r- (&louieblouie)
It was not the first time when I posted this info ... I did it in August (IIRC) ... thx to the miracle of reading and comprehension ability ...
Some clarification:
1.) Exclusivity
EU
- V will have regulatory exclusivity till (at least) "January" 2031 (max. till "January 2032 if new indication will be approved) independently from any patents.
- EU R-IT patents are valid (currently) till 2033 (or 2034). It is a possibility that generics will not challenge the patents for this 2 years ("January" 2031 - 2033) ... but will - no doubt - if new patents will be granted and the patented period (w/o regulatory exclusivity) will became 8 years ("January" 2031 - 2039).
Other country / region
Most (all?) have a regulatory exclusivity but are not the same. e.g. China have 6 years ... for MARINE but max 5 years (but more likely less) for R-IT.
I did not do a full DD (did not check the exact - current - status) but here is some info:
- Trends and Developments in China’s Life Sciences Industry
- China Drug Administration Proposes Pharmaceutical Data Protection Guidelines
- Improvements in China Drug Registration – Opening the Door to the China Market for Global BioPharma
- China plans to increase market exclusivity term for pharmaceuticals based on improved pharmaceutical trial data protection
- China’s Biopharmaceutical Strategy: Challenge or Complement to U.S. Industry Competitiveness?
2.) Patents
First of all:
(i) Opinion / view by the FDA is totally irrelevant ... they are not "dealing" with patents, administer in the OB only. They are evaluate the science (and do not the legal) side. The strongest, patented method of use could be rejected because no scientific / health benefit and the weakest, most obvious MoU could be approved if it has a health benefit.
(ii) Scientific proof and legal possibility are different standards ... legal does not require a proof, doubt could exist.
MARINE
US: Gone ... It is on respirator (en banc review ... SC ...) but it is brain-dead the respirator will be switched off before EOY
ex-US: Of course other jurisdictions could rule differently ... but more likely will not ... at best: a coin flip
R-IT
At least JELIS is a nail in the coffin ... (rational behind JELIS list a lot of other prior art also). If a layman could see JELIS as "indicative" no question the POSA could also ... Please note: JELIS baseline TG 109 - 220 mg/dL (mean/SD: 153 mg/dL) vs REDUCE-IT 81 - 1401 mg/dL (median: <150 11%, 150/<200 28%, <200 61%) ... it is not close enough ... it cover / overlap
3.) Future
I do not see a scenario in which the Co exist after 2035 ... unless they make a portfolio ... but it requires money, aka dilution. I see 2 possibility:
(I) GIA: Optimize / run the business till end of the product, collect as much as possible ... but it is not too sexy, is not a double digit pps
(II) BO / out-license: Sell the Co ... if anybody interested or out-license the entire World and collect the royalty till it is exist.
4.) Valuation
a.) Cash on hand is not relevant ... as it is vary month by month and has a 1x multiple, added to the calculated value (c.)
b.) Loss carry forward: it is applicable as
b.1: Amount x Tax % (e.g. 1bn LCF with 25% tax rate worth 250 million)
b.2.: Depends on the buyer nationality the local ruled should be applied e.g. some countries it could not be used in the first year because of limitation ... till 50% of the profit or max. 100M / year
b.3: has a =< 1x multiple, added to the calculated value (c.)
c.) If ... and it is a big if ... anybody interested in a BO, it will not use a peak sales multiple (or any other "top-down" / multiple valuation). Multiplicator is not applicable in case of a fix lifecycle ... the length could be debated but no question it has an end.
The valuation will be prepared as:
- bottom-up (full / detaild P&L and Cash-Flow)
- for the period of regulatory exclusivity (due to the coin-flip MARINE patents and existing / high doubt regarding R-IT patents. (To avoid any doubt: it will value the "patent only" period also but it will have a huge discount, it will serve as a "negotiation tool")
- based on free cash-flow
- country by country basis
- year by year (more likley the frist 1-2 years ona month by month basis)
- will be discounted to NPV (net present value; e.g.: with 10% discount rate the a 1bn in the 5th year worth 590M and the a 1bn in the 10th year worth 349M ... 1bn over 10 years / 1bn in every year - total 10 bn - worth 5,86 bn now ... but with run up - e.g. 0,1 / 0,5 / 0,75 / 1 / 1 ... it is total 8,35 bn - worth 4,46 bn now ...
Please note: I idd NOT give a valuation / PT ever ... If I wrote any number I noted in every cases "it just for example", not enough data / info available to make a real calculation. (Most of my numbers - as the best approach, due to the differences between countries (GDP, population, etc) - was based on "50"% of potential US revenue ... as the "typical" revenue ration for other drugs / Co.)
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If everybody come your way, it is time to stop for a second and check that you are on the right side of the highway or not ... going on - claiming that everybody is stupid - could be deadly ...
Best,
G
ps.: Baker B' holding:
- sold 23,771,368 in Q2
- most likely sold (at least) 2,385,078 in Q3 ... but could be 5,160,378 ... or more
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"Final" notes ...
I commented / replied to all relevant posts during the last 2 weeks ... but I will not follow the board anymore since most of the posts are over my paygrade ...
US:
- It gone ... not tomorrow but within a foreseeable future (2022 ... but definitely by 2023/24)
- best case: they could find a solution (authorized generic, cooperation with a generic, etc) that will cover the cost of base / general operation
(see more below)
EU:
- It is not a question of what but when ... it will be approved (most / majority of drugs have to go through all - 3 - phases of the approval process ... opinion after 180 days is not a standard). It is on track, nothing wrong with the process.
- GIA vs partnership vs BO: the best is the highest value ... it could be GIA (if partnership / BO scenario provide less value than the GIA). I am 101+ sure it will be (was?) decided based on numbers and not by emotion
- Meanwhile EU is more complex (as approval / launch) than US ... it is simpler than US (after launch / reimbursement agreements)
- V could be launched without reimbursement agreement (eg. in Germany) and secure the reimbursement after the launch
- The governments will not allocate a given fund for V but a given reimbursement % ... revenue will not be limited by the governments
China: Earliest launch end of 2021 ... but more likely 2022
Middle East / North Africa: "interesting" ... three approvals, two launch after 4 years ... more likely will not be a relevant item
Row (S/M America, Russia, etc.): More likely looking for a best partnership / BO offer ... will be decided after (with?) EU launch
Management / BoD / Co: Are they the best? No. Are they the worst? No.
Most critics are hindsight or based on lack of experience ... (It is amazing what type of info are requested by shareholders, what some thinks should be shared / released by the Co.).
All together ... but first of all:
The Co value is equal with regulatory exclusivity (e.g. 10 yrs in the EU till 2031) nothing more (except some "special" cases ... e.g. EU could worth an additional 3-4 yrs IF the patents will NOT be extended till 2039. I think generics will not challenge R-IT patents for 2-3 yrs but will for 9 yrs.)
R-IT patents will be invalidated based on JELIS "before" the case will be filed ... A lot of us seen R-IT result obvious based on our DD / JELIS.
More likely the Co will be GIA forever unless somebody will make an offer but it is a coin flip.
If an offer will be made I expect something like $3B ... something below $4B ...
It could be a speculative play @ $2.50/3.00 but could not be a strategic investment.
Good luck to you if you still hold ... If I were you I would sell the next "jump" ... "anything above $"4.50" ... if it will be "available" ...
Best,
G
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You will not find it anywhere ... this "magical" 5% threshold does not exist ... for this aspect, for inducement.
It is relevant for contributory infringement. Generics commit contributory infringement IF the generic only reasonable use is an infringing use ... only use it for R-IT indication.
But it is not the case here, the generics could be used for MARINE indication also ... and this use is substantial, is not not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.
[In the MARINE patents case] the contributory infringement claim was denied because a substantial use (app. 5%) was treatment for LESS than 12 weeks ... for an "unpatented", non-infringing use.
Best,
G
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Nope:
03.26: It was the 120-days letter (List of Questions / LoQ)
July: Amarin answered LoQ before mid-July ... the clock started to ticking again
09."14": 180-days letter (List of Oustanding Issues / LoOI)
Amarin will have 3-6 months to answer the LoOI.
Best,
G
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Do not let be fooled by one, two ... or eight poster. Enough is enough ...
Generics could:
- order / produce enough API for 7 billion people
- present any sales forecast (what they did not do ...)
and "all" gV could be dispensed for R-IT indication (it will be off-label ... since the generics label does NOT contain R-IT indication)
they will NOT liable for inducement (infringement of R-IT patents) till:
- their label is about MARINE indication only
- they did not market / sell (mean promote) generic for R-IT indication (not likely they will do this)
It is plain and simple.
Best,
G
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TEVA tentative approval is "interesting". They got tentative approval because the FDA
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(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one but at least remove the existing sticky. Thx.
(i) “standard” EMA timetable
- September 17: List of Outstanding Issues (LoOI)
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- January 28: Day 210 Opinion by EMA / recommendation of approval
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
(ii) “shortest” EMA timetable (after clock-stop for responses)
- September 17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November (9-)12: Day 210 Opinion by EMA / recommendation of approval
- January 18: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
(iii) “shortest” EMA timetable (after immediate responses**)
- September 17: Day 180 List of Outstanding Issues (LoOI)
- September 22*: Response to Day 180 LoOI, September 17
- October (12-)15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
*clock restart
** This timetable is only used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.
Best,
G
Notice: This post will not be updated anymore.
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Agenda. Will be posted Monday or Tuesday.
CHMP: Agendas, minutes and highlights
Best,
G
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We will not know the details.
Best,
G
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No problem. It was "reported" by a lot of posters ... without read / understand the presentation.
Best,
G
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Authorized generic is exactly the same as the brand. Same label, same indications, produced in the same factory. The only difference is the name.
Best,
G
ps.: LoOI = List of Outstanding Issues
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I know ... my post was the "mirror" / "copy" of 8's post about other posters ...