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Total Monthly Retail + Institutional Data Feb-2016
V
TRx: 60,526 {vs 58,265; +3.88%} ATH – Sector -1.60%
(Inst# 3,680 vs 4,154)
L
TRx: 19,314 {vs 21,917; -11.88%}
(Inst# 6,654 vs 8,432)
Gen L
TRx: 279,295 {vs 284,782; -1.93%}
(Inst# 25,205 vs 23,176)
V Monthly Retail + Inst. TRx Market Share: 16.85% vs 15.96% --- ATH
Scripts Update for Week Ending 11/3
V
TRx: 14,035 {vs 14,643; -4.15%} Sector -5.17%
NRx: 5,856 {vs 6,191; -5.41%} Sector -5.21%
Ref: 8,179 {vs 8,452; -3.23%} Sector -5.16%
L
TRx: 2,819 {vs 3,119; -9.62%}
NRx: 933 {vs 1,084; -13.93%}
GenL
TRx: 60,657 {vs 63,979; -5.19%}
NRx: 23,633 {vs 24,712; -4.77%}
V TRx Market Share: 18.11% vs 17.91% --- ATH
V NRx Market Share: 19.31% vs 19.35% --- (ATH = 19.36%)
V Ref Market Share: 17.33% vs 16.99% --- ATH
Total Monthly Retail Data Feb-2016
V
TRx: 56,846 {vs 54,111; +5.05%} ATH was in Dec-15 with 60,117 -- Sector -1.70%
NRx: 24,061 {vs 21,884; +9.95%} ATH -- Sector +2.52%
L
TRx: 12,660 {vs 13,485; -6.12%}
NRx: 4,380 {vs 4,530; -3.31%}
Gen L
TRx: 254,090 {vs 261,606; -2.87%}
NRx: 99,760 {vs 98,640; +1.14%}
V Monthly Retail TRx Market Share: 17.57% vs 16.44% --- ATH
V Monthly Retail NRx Market Share: 18.77% vs 17.50% --- ATH
Penn Study Shows a Form of Genetically Elevated "Good" Cholesterol May Actually be Bad
I am not sure if this was posted before, but below the link;
http://www.uphs.upenn.edu/news/News_Releases/2016/03/rader/
"he generally accepted medical maxim that elevated HDL cholesterol (HDL-C) is “good” has been overturned by a multi-center, international study, led by researchers from the Perelman School of Medicine at the University of Pennsylvania. They show that a certain genetic cause of increased HDL-C may actually be “bad,” noting that a specific mutation in a gene which encodes a cell receptor protein that binds to HDL prevents the receptor from functioning. The mutation causes an increased risk of coronary heart disease even in the presence of elevated levels of HDL-C or “good” cholesterol. Their findings are published this week in Science......"
For those into the old methods. Comparison between New Reporting vs Old: TRx is now around 17,000 & NRx around 8,000
Scripts Update for Week Ending 04/03/2016
V
TRx: 14,643 {vs 13,830; +5.88%} Sector +5.99% -- ATH
NRx: 6,191 {vs 5,906; +4.83%} Sector +3.52% -- ATH
Ref: 8,452 {vs 7,924; +6.66%} Sector +7.64%
L
TRx: 3,119 {vs 2,887; +8.04%}
NRx: 1,084 {vs 993; +9.16%}
GenL
TRx: 63,979 {vs 60,404; +5.92%}
NRx: 24,712 {vs 24,000; +2.97%}
V TRx Market Share: 17.91% vs 17.93% --- (ATH = 17.93%)
V NRx Market Share: 19.35% vs 19.11% --- (ATH = 19.36%)
V Ref Market Share: 16.99% vs 17.14% --- (ATH = 17.14%)
Suntrust Update: will upload the file tmw.
Settlement of 1st Amendment
Litigation Removes Overhang
Free speech terms set (+) precedent for industry’s ability to
promote off-label
AMRN settles with FDA, making preliminary ruling final
As we expected, AMRN reached settlement terms with the FDA resolving First
Amendment Litigation (Amarin Pharma, Inc. et al. v. FDA et al.) regarding off-
label promotion of Vascepa. Under the terms of the agreement, the FDA &
the US government agree to be bound by the August 7, 2015 declaration by
the court (click here to view our note on the initial decision) enabling AMRN
to engage in truthful and non-misleading speech promoting the off-label use
of Vascepa in the ANCHOR population that represents 36M patients with
elevated triglycerides (≥200mg/dl to 499mg/dl) vs. on-label promotion for the
3.8M patients represented by the MARINE population (500mg/dl to 2000mg/
dl). In addition, AMRN is able to discuss the cardiovascular benefits seen in
the JELIS populations where EPA (the active ingredient in Vascepa) reduced
major cardiovascular events (MACE) by -19% overall (P=0.011) and -53%
(p=0.043) in a sub group of patients with elevated triglycerides ≥150mg/dl.
AMRN initiated its promotion in 3Q15 in advance of settlement discussion & is
promoting the JELIS results in its current cycle of promotion. AMRN’s ability to
promote off-label will contribute to an acceleration of TRx’s in front of results
from its REDUCE-IT outcomes trial. We view the AMRN First Amendment win
as not only important for AMRN’s ability to fairly promote the off-label benefits
of Vascepa, but a win for the entire biopharma industry’s ability to fairly promote
peer reviewed published studies of off-label uses for its products as long as it
follows the key settlement terms that include the following:
• FDA and US gov’t agree to be bound by the court’s Aug. 7th, 2015 decision
• AMRN bears responsibility for assuring that communications to doctors
regarding off-label use are truthful and non-misleading
• Settlement terms are not to be construed to limit AMRN’s constitutional rights
of free speech
• FDA will provide AMRN with an optional preclearance provision through 2020
for new off-label claims
• Both parties have agreed to a dispute resolution provision designed to avoid
future litigation
• The court will retain jurisdiction over the matter to ensure compliance with and
resolve any future dispute arising from the settlement order.
Judge Paul A. Engelmayer of the US District Court for the Southern District of
NY approved the settlement terms proposed by the parties, thus concluding
the underlying litigation. Click here to view the settlement.
Settlement enables $120M in ’16E sales; REDUCE-IT interim on deck
As mentioned in our Feb 18, 2016 note (click here), we expected a settlement in the litigation prior to the
March 18, 2016 deadline, and as such, we modeled TRx growth based on uninterrupted promotional
activity for Vascepa. Therefore, we leave our modeled assumptions unchanged, however the timely
and favorable resolution of the case give us more confidence that AMRN meets its 2016 sales targets.
We estimate $120M in Vascepa sales in 2016, which is at the top end of AMRN’s $105M-$120M
range (see Exhibit 1). Further, the settlement, combined with the January 22, 2016 decision by the
US District Court of NJ to grant AMRN’s motion to dismiss all patent infringement litigation, should
materially lessen litigation expenses for the remainder of 2016. We assume AMRN meets its target of
keeping SG&A expenses flat with 2015. We model $91M in SG&A, which is flat YoY. The next catalyst
is REDUCE-IT interim look in mid-to-late 2016. The REDUCE-IT study remains on track both for its
pre-specified interim analysis scheduled for later this year, & more importantly the onset of the final
targeted event in the study by the end of 2017. The commercial opportunity to improve patient care
presented by REDUCE-IT eclipses the opportunity presented by AMRN’s successful ANCHOR study
since it would cover 70M patients that have above normal triglyceride levels after statin therapy. The
70M patients in the US with high triglyceride levels are comparable to the number of people with high/
elevated cholesterol levels.
It's good to have the court in the back mind of the FDA, same court / judge who ruled against them in the past. FDA treatment towards AMRN will not be the same as before with this ruling, just my humble opinion
Judge approved the settlement. Just PRd by AMRN
Sts, exactly, that's what I was thinking of and wrote about earlier
I totally agree with you...let's wait and see :)
Invest, that was clear in various CC, JT mentioned the the promotion was going via stages. They didn't want to over load data on doctors and freak them out.
Jelis' promotion started end of Dec-15...Patience is a virtue if you believe in science and the various benefits of V shown via Zum's article and JL's in detail explanations
MOG,
They got nothing u say....how about being able to promote off label since August-15 ruling and now it's being official. Amarin got all what they wanted from this case.
What is of interest for me, which I still can't explain is "the procedure described in this paragraph applies only to proposed communications about the off-label use if Vascepa that amarin has not yet communicated to doctors in promotion and will cease to be in effect as if December 31, 2020"
What other off label are we talking about, hinting at, already discussed with the FDA in these negotiation so it was included in this settlement
Scripts Update for Week Ending 26/02
V
TRx: 13,830 {vs 13,479; +2.60%} Sector +2.08%
NRx: 5,906 {vs 5,813; +1.60%} Sector +2.39% --- ATH
Ref: 7,924 {vs 7,666; +3.37%} Sector +1.88%
L
TRx: 2,887 {vs 3,042; -5.10%}
NRx: 993 {vs 1,081; -8.14%}
GenL
TRx: 60,404 {vs 59,025; +2.34%}
NRx: 24,000 {vs 23,285; +3.07%}
V TRx Market Share: 17.93% vs 17.84% --- ATH
V NRx Market Share: 19.11% vs 19.26% --- (ATH=19.36)
V Ref Market Share: 17.14% vs 16.90% --- ATH
Thanks JL, interesting read
H.C.Wainwright Quarterly Update
https://drive.google.com/file/d/0B1gB2YESBJV7VW1Yc1ZSNFJ2X1U/view
* Ahead of the expected heightened volatility, volume and likely share price appreciation, we believe, leading into the interim readout event this year, we reiterate our Buy rating and a $10 PT.
* Temporarily setting aside the less predictable data analysis time frame, assuming the numbers used for the study’s power calculations (placebo event rate of 5.2% and a RRR of 15%), the 967th event is expected to occur in the February-March time frame, aka now (or soon or already). Because of the variable data analysis time frame, it may be difficult to interpret the implications behind a later than- expected interim readout: is it driven by a lower placebo event rate, higher RRR, or simply longer data analysis time? We believe it is likely to be the latter two (higher RRR and longer data analysis)
* Following management’s emphasis on a potentially prolonged data analysis time frame due to the need to adjudicate MACE primary events and the large-scale, international reach of the study, we find it prudent to conservatively extend our own projected data analysis time frame by 2 months while maintaining our assumptions on the primary events trajectory itself (see appendix for full projection timetable).
i meant on a personal level :)
couldbebetter;
"Sam, do you think AMRN will be bought out after Reduce-It results or do you think they will go it alone?"
That's the few million $ question...will I cash it straight after reduce-it, will I cash it later in the future via organic growth and new pipeline of drugs as I believe in science and do not mind waiting, or will it all vanish and I barely cash out my investment and it will always be remembered as; that would have been nice if it happened?!
Couldbebetter;
below is an extract from yesterday's call...foreign deals were mentioned and discussed by John Thero;
" I would say that in parallel to the Eddingpharm, we are active in talking with potential partners and a variety of other different geographies. As I had commented a bit earlier, there are pros and cons to whether we do something before REDUCE-IT results or after REDUCE-IT results. I’ll take Europe for example. In Europe when -- [indiscernible] which is the name of [indiscernible] over there launch -- it was launched by different companies and different countries and therefore it has different labels, different reimbursement, different dosing. And some of the folks we are talking with would argue, let’s piggyback what's already done there and let’s get the markets quicker based upon the kinds of labels that already exist despite the lower reimbursement. Others would argue, is a much better economics for waiting and going Pan European potentially higher reimbursement rates with outcome study results. We are valuating both approaches and intent to do what we think is in the best interest of overall shareholder value. Some other geography’s aren’t quite as complicated as Europe in terms of that history of existing products in the market place, but we are actively pursuing and there is interest. It’s a matter of finding the right terms for the product, and we believe this product has a huge opportunity and we don’t want to just do a deal to get a deal done. We want to do the right deal."
SunTrust 4Q15 PostView
https://drive.google.com/file/d/0B1gB2YESBJV7dFVUSUJPeWxjNlU/view?usp=sharing
Oppenheimer Quarterly Update
https://drive.google.com/file/d/0B1gB2YESBJV7R0E4d0VHYVlJajQ/view?usp=sharing
SunTrust Initial Thoughts 4Q15
https://drive.google.com/file/d/0B1gB2YESBJV7ZVY2a05Relc2Sk0/view?usp=sharing
Scripts Update Week Ending 19/02
(Short Week)
V
TRx: 13,479 {vs 13,216; +1.99%} Sector -0.06% --- ATH = 14,004
NRx: 5,813 {vs 5,532; +5.08%} Sector +0.36% --- ATH = 5,815
Ref: 7,666 {vs 7,684; -0.23%} Sector -0.34%
L
TRx: 3,042 {vs 2,927; +3.93%}
NRx: 1,081 {vs 1,007; +7.35%}
GenL
TRx: 59,025 {vs 59,451; -0.72%}
NRx: 23,285 {vs 23,533; -1.05%}
V TRx Market Share: 17.84% vs 17.48% --- ATH
V NRx Market Share: 19.26% vs 18.40% --- (ATH = 19.36%)
V Ref Market Share: 16.90% vs 16.88% --- ATH
I still cant figure that out properly
The best thing would be to follow the weekly market share and on a monthly basis the total Rx numbers (after the publishing of the inst.)
Scripts
Institutional Numbers are out for Month of January-2016, totaling 4,154 (+2.77% from Dec-15 4,042)
The link below should kind of explain the change of reporting system. It includes Old TRx total numbers and the New TRx Numbers + Institutional
The problem is since Inst. is on a monthly basis and TRx are weekly and you have weeks that ends 3rd or 4th of the month, so no accurate numbers can be done. Anyhow i used the same time frame for both old and new and the difference can be seen in the following link;
https://drive.google.com/file/d/0B1gB2YESBJV7eVAxOXN1WU41VWs/view?usp=sharing
I hope this helps. We should continue from now on to follow the change in numbers based on the new reporting model and as i said before, Market Share should be the main focus
SunTrust Update (Feb 18 2016)
Link:
https://drive.google.com/file/d/0B1gB2YESBJV7eUhXX1RfMUM5Zmc/view?usp=sharing
Main Points:
- AMRN should turn cash flow positive in the latter part of 2016 Our model assumes AMRN turns cash flow positive in the latter part of ’16. This estimate is consistent with AMRN’s projection that its will be free cash flow positive in ‘16 excluding R&D, which we model at $17.2M. We expect AMRN to exit 2015 with $107M in cash & equivalents, consistent with AMRN’s prereleased cash balance, and $101M at the end of 2016. In 2017E, we model AMRN to be profitable and free cash flow positive.
- Reiterate Buy/$6PT based on DCF analysis.
- On February 17, 2016, the Southern District Court of New York granted its fourth extension to a stay of proceedings in AMRN’s case against the FDA regarding their promotional rights around Vascepa. Judge Paul Engelmayer granted a further stay of proceedings until March 18, 2016, however, in the order, he included the following commentary: “…the Court notes that as of March 18, 2016, more than seven months will have passed since the Court’s ruling on Amarin’s application for preliminary relief. To the extent the parties may seek further stays in this case on account of ongoing settlement discussions; the Court will expect a more fulsome explanation as to the procedural status of settlement discussions and why a further stay is necessary to enable those discussions to reach completion.”
- Based on Judge Engelmayer’s comments in the order, we believe it’s unlikely that another stay request will be granted. We look for additional details on AMRN’s 4Q15 conference call that is scheduled for February 25th. This appears to be AMRN & the FDA’s last opportunity for a settlement before the proceedings continue. Therefore, AMRN and the FDA need to reach a mutually beneficial settlement in the case before the March 18, 2016 deadline, as a settlement would remove an overhang from AMRN’s Vascepa promotion & reduce legal expenses.
- We expect the full effect of the JELIS promotional efforts to be seen the Vascepa volumes in 2H16.
- On January 22, 2016, the District Court of NJ granted Amarin’s motion to dismiss all patent infringement litigation related to Vascepa’s abbreviated new drug applications (ANDA) without prejudice, although an appeal can be filed within 30 days. of Jan. 22, 2016, there is no pending Vascepa patent litigation.
- AMRN Catalysts
1) Vascepa commercial execution in the ANCHOR population & through the promotion of the JELIS Outcomes study which should have a beneficial effect on weekly NRx/TRx trends.
2) REDUCE-IT enrollment (n=8,000 patients) should be completed in 1H16.
3) Continued settlement discussions between FDA & AMRN in First Amendment case, which is stayed until March 18, 2016.
4) Additional Vascepa business development/co-promotion deals in ex-US markets (Eastern/Western Europe, LatAm, Asian markets).
5) REDUCE-IT interim look in 2016, with trial completion in 2017 after 1,612 CV events (stroke, heart attack or revascularizations) are reached, with full results published in 2018.
6) REDUCE-IT sNDA filing in 2017, with FDA action in 2018.
Scripts Update Week Ending 12-02
The following numbers based on the new reporting system. As mentioned before, it is under-reporting old numbers. Market Share should be the focus.
V
TRx: 13,216 {vs 13,613; -2.92%} Sector -5.64%
NRx: 5,532 {vs 5,815; -4.87%} Sector -5.00%
Ref: 7,684 {vs 7,798; -1.46%} Sector -6.06%
L
TRx: 2,927 {vs 3,171; -7.69%}
NRx: 1,007 {vs 1,081; -6.85%}
GenL
TRx: 59,451 {vs 63,329; -6.12%}
NRx: 23,533 {vs 24,760; -4.96%}
V TRx Market Share: 17.48% vs 16.99% (ATH = 17.68%)
V NRx Market Share: 18.40% vs 18.37% (ATH = 19.36%)
V Refill Market Share: 16.88% vs 16.09% --- ATH
STS, sorry i have no idea or data about that
SCRIPTS FOLLOW-UP
Below you can find the link regarding the new reporting method, 18 pages to read.
I don't have lots of time to go through all of it, but i guess what is of interest to us is the following;
1- Expected Changes: Reported volume for brands have declined due to improvements in capturing sold prescriptions
2- Reporting done for sold prescriptions now (those purchased by a patient and left the pharmacy bin) VS. old dispensed prescriptions (those submitted, filled by the pharmacy, and ready for pick up)
3- Difference in TRx volume at the national level for branded products: approximately 4% decrease in overall Rx Volume for year 2014
4- Monthly Institutional Data Release: Published on the 2nd Wednesday after the 2nd Saturday of the month. That usually falls on Wednesday of the 3rd week +or-
Link: https://drive.google.com/file/d/0B1gB2YESBJV7Z0pEMVpSZXV6WXc/view
Baker brothers bought 5million PRN the exact number sold by Aristeia Capital. BB still holds the same number of normal shares totaling 2.2million
I am intrigued by the selling of 2.3million PRN of Citigroup, interested to know the firm that bought them.
On another note, even though it ain't a big block, but I am happy with the increase of shares of Goldman Sachs, now holding more than 400,000 shares. It is good to have these really big players in the market betting on your share price increase
i will email you 1st thing tmw as i already left the office.
Regarding your 1st msg, the inst. and integrated numbers won't help as the numbers are only till year end 2015. Data instead of graph, i will email them tmw
Bio, indeed it is an ATH in NRx
Under Inst. there is no data, and the messed up part is that there is no TRx and NRx under that, so it will be hard to find out
I worked on few numbers and what is known that since beginning of year 2016, the new scripts system is under-reporting TRx by an average of 14.20% (around 2K+) & under-reporting NRx by an average of 20.09% (around 1.3K)
Based on that, NRx should be more than 7,050 and TRx close to 16K
Bio, send me ur email if you are interested in going through the numbers
SCRIPTS UPDATE WEEK ENDING 05/02/2016
Well something has changed in symphony reporting which i still cant figure out till now.
Bloomberg terminal used to report the scripts on a weekly basis for Total TRx Count and NRx count, easy, simple and straight to the point.
Starting this week a change has been made, TRx & NRx are reported on a weekly basis but they are divided now. Divided into 2 items; Retail & Institutional
Retail are reported on a weekly basis while Inst. are reported on a monthly basis and this is where things are messed up
Going back to old numbers, none of them match due to this discrepancy in reporting.
Anyhow, until we manage to figure this out (need your help and suggestions pls), the link below shows the latest data, via graphs showing the numbers of the new reporting method (just for retail as inst. is done on a monthly basis now)
V numbers looks good; in the new reporting system Retail TRx seems to have increased by +7.21% and Retail NRx @ ATH increasing by 6.54%
L & GL Retail numbers; L TRx +3.66% NRx -1.01% and GL TRx +5.39% NRx +6.71%
Sector update, again lower numbers, just the retail TRx +5.63% NRx +6.40%
I hope this makes sense guys, below the link;
https://drive.google.com/file/d/0B1gB2YESBJV7eTVwTmhObS0xVDA/view?usp=sharing
something changed in the scripts update,i cant figure it out, now its messed up, retail scripts posted alone (weekly) while institution numbers are also alone but just posted on a monthly basis...numbers from past weeks doesn't even match.
I am sorry but i am out of here, have a nice weekend. I hope by Monday things would be more clear
13F Update until 12-02-2016 for those interested with all received updates till this moment
link: https://drive.google.com/file/d/0B1gB2YESBJV7NUpLdXRpSTZIY3c/view
not updated yet
Camber Capital Management LLC sold of all their remaining holdings as of 31-12-2015
They dumped 6,500,000 shares before year end
is it, change of outlook? change of internal business model and market exposure? no faith in the company? internal solvency problems? year end tax issue?
Well as Mog mentioned in one of various posts, the liquidation started before the 30-09-2015 release
I report in an objective way, positive and negative news.
Lots of 13F release still in the pipeline, to be more accurate around 60 more institutions haven't reported yet
Nothing updated yet regarding the scripts
Those aren't updated numbers...I will attach an excel tmw so you guys are properly updated
Renaissance Technologies, isn't that the firm Hamburg's Husband works at or is a partner??
If that's the case, that might be really interesting