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No Scripts update yet. Seems it will be delayed like last week.
It might be a delay or this is the new norm, late updates (i hope not)
BB ain't that what you were talking about??
Bull Case $16 // 405% Upside // DCF Derived (SunTrust)
• Vascepa sales accelerate to more than double ($1.5B) our base case 2021 estimate of $645M, assuming broad access (1 in 3 adults) from approval in the MARINE (4M), ANCHOR (37M) and REDUCEIT (34M) patient populations representing a ~75MM-patient market in the US.
• The 5-year partnership with Kowa adds to its share of voice with primary care/cardiovascular prescriber base allowing it to exceed sales expectations.
• REDUCE-IT pre-specified interim analysis by the independent data monitoring committee at 60% of the targeted events is anticipated in 2016, with 100% of the targeted events anticipated by YE2017. Following results in 2018, REDUCE-IT is added fully to Vascepa's label.
• AMRN arranges a royalty on partnered international Vascepa sales.
• AMRN retains exclusivity on Vascepa beyond 2024 (assuming 3 years add back due to FDA delays under Hatch-Waxman).
SunTrust Update
Adjusting ‘16E on Higher Share Count & R&D;
Risk/Reward Appears Attractive Balance Sheet Strengthened; Bull & Base Scenarios Imply Attractive Upside
https://drive.google.com/file/d/0Bxf3SeLDbKY6aWM1SmplVFFCdlk/view?usp=sharing
Total Monthly Retail Data July-2016
V
TRx: 70,792 {vs 70,108; +0.98%} – Sector -2.17% -- ATH
NRx: 27,348 {vs 28,152; -2.86%} – Sector -4.28%
L
TRx: 9,326 {vs 10,198; -8.55%}
NRx: 3,675 {vs 3,769; -2.49%}
Gen L
TRx: 254,400 {vs 261,620; -2.76%}
NRx: 92,060 {vs 96,672; -4.77%}
Monthly Retail TRx Market Share: 21.16% vs 20.50% --- ATH
Monthly Retail NRx Market Share: 22.22% vs 21.89% --- ATH
Great scripts numbers...ATH and I think great market share increase
Will update my numbers next week
No Scripts
Sorry guys but i am off for the weekend
Nothing updated yet. I hope they post them in the coming 2hrs as i will be leaving my office after
agree. But shoe isn't guaranteed. If they wish too, they have the chance that's why the PR didn't include it in the net proceeds
Have a nice day and Good Luck
Merc: The net proceeds to the company from this offering are expected to be approximately $56.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The offering is expected to close on or about August 16, 2016, subject to customary closing conditions
21,000,000 @ $2.85
Total proceeds ~$56.1 million
Well done Mercator :)
http://www.streetinsider.com/Corporate+News/Amarin+Corp+plc+%28AMRN%29+Prices+21.1M+Offering+at+%242.85ADS/11928757.html
Marzan,
I agree with you and it was mentioned clearly that they will act based on market conditions. The call is in their hand
My question is: Why announce this and nothing is concrete yet &or nothing is 100% planned and the deal is fixed?
All opinions are welcomed
Glad i did :D
But you're all welcome to come leave comments there if you want so I can make you look bad there too.
Now i fully understand your strategy
You mean leave comments so i get paid, as you will be paid by click and comment
You came in here and tried to bull*(&^ your way and none took you seriously, but that was done on purpose, pre-article release, so people follow you and your article and reply to you
At the end of the day its all about getting paid by SA or your short bosses
As i mentioned to your friend Moggy or maybe yourself in disguise, save yourself this hassle and i can offer you a better pay than your short friends / bosses without the need to write any article, just by saying nothing you will get paid and make the humanity a huge favor
Good luck with your position and i am sure that you will make money as always. At the end of the day it seems your Biotech God with a 70% bull%^&* success rate. Sorry but i cant help myself and this needs the biggest, loudest Hallelujah & LOOOOL
H.C.Wainwright&Co. Update
Amarin’s Strategic Alpha Trade-Off
Rating: Buy
Price Target: $10
A small price to pay for a material data event.
On yesterday’s earnings call, company gave three waves of distinctly positive news, ranked here in increasing order of importance: (1) the company’s underlying business continues to exceed Street expectations (2Q revenue for Vascepa was $32.8 v. consensus of $29M); (2) modification of REDUCE-IT protocol to expand secondary and tertiary endpoints; and (3) the addition of a second interim efficacy analysis on tap for mid-2017. The main cause of investors’ malaise in Amarin thus far has been the lack of near-term catalysts, especially given the widespread belief that the upcoming interim (in 1-2 months) is expected to be a study continuation. However, we believe the announcement of a second interim analysis significantly changes the story. Unlike the first interim, the second interim not only has a more mature information bracket (80% of events v. 60% of events from first) but also a statistical hurdle that is significantly less onerous (p=0.022 v. p=0.0076 from first). Importantly, due to the specific type of alpha spending function employed itself (the O’Brien-Fleming), the nominal p-value for the full study stands mostly unscathed (p=0.0422). Now, we have to applaud management for finding an apparent best-of-bothworlds solution: buying in on a non-zero chance to stop the trial nearly half a year earlier without significantly compromising the integrity of the REDUCE-IT crown jewel. We believe this additional catalyst will finally begin to engage those investors with shorter time horizons who had initially intended entry closer to full study readout (end of 2017/ early 2018). Following what we believe to be a clever strategic move, we reiterate our Buy rating and $10 PT.
Alpha can’t buy you everything but it may buy you time.
The alpha spend here on the second interim analysis can help timing in two ways: allows an earlier look at the data for the possibility of an early stop (increased likelihood compared to the first interim), and help expedite the data locking process for the final data analysis. Based on our previous research into the time table of events rates and assumptions about adjudication process and data analysis, it is likely for the 80% event trigger to occur sometime in the March-April 2017 timeframe (company guided 1H17), with interim readout ~3 months after that in June-July 2017 (company guided mid-2017). In the event of an early stop at the second interim (in our view, non-zero but still less than 50%), that would shave off more than half a year compared to full study readout. In the event of a study continuation, the adjudication process and data lock of 80% of events should also significantly expedite final data analysis when the time comes.
On a success scale of 0 to 10, there are many 7’s and 8’s.
In our prior note, we have pointed to the underappreciated value of the first amendment win as it pertains to the REDUCE-IT study: (1) it effectively converts the trial readout from a binary event to a continuous event with different shades of win; and (2) it allows potential to promote REDUCE-IT outcome prior to the sNDA review. Now, with the addition of several more secondary and tertiary endpoints to the protocol, this point rings truer and louder than ever: it is more likely than not that there will be subgroup signals in this cohort of 30 endpoints. In the unlikely event of a REDUCE-IT miss, there is added comfort that a scientific publication exploring these signals are fair grounds for “truthful, non-misleading” promotion among physicians.
Continued growth in clockwork baseline business continues to de-risk REDUCE-IT.
Second quarter revenue for Vascepa continued to outperform Street consensus and our own estimates ($32.8M v. Street’s $29M v. our estimate of $30M). With such strong quarter-to-quarter growth (+29.7% over 1Q16) driven by new patient starts as well as switches from other omega-3 therapies, this gives us increasing confidence that the underlying business may begin to support the majority of the current share price. To be fair, REDUCE-IT is likely no longer a free optionality at current trading levels in light of the stock’s substantial appreciation in the past week (from $2.39 to $3.28, nearly 40%). But any sustained or continued growth in quarter-to-quarter sales will significantly offset the costs and associated risks of the outcome study.
2Q16 financial update and rise in guidance.
Reported yesterday, net product revenue for the second quarter was $32.8M (+29.7% QoQ). Management increased its guidance for FY16 sales revenue to the range of $112–125M (from $105-120M). On the operating front: COGS were $8.9M (+28% QoQ), SG&A costs were $26.0M (-7% QoQ), R&D costs were $12.6M (-8% QoQ). Under GAAP, Amarin reported a net loss of $13.4M, or basic and diluted loss per share of $0.07. The company exited the quarter with cash and cash equivalents of $72.5M.
Is today's pre market high price trade the usual short seller's hidden msg?!?!
It happened so many times before, early pre market trades, small quantities followed by a bear raid during actual trading hours.
I hope not, IMO things are changing in favour our Amarin, but lets wait and see it what happened several times before is gonna be done again
Yup
16/8 Retail Monthly Data
24/8 Institutional Monthly Data
2Q16 PostView: 2016 Estimates Maintained as Vascepa Growth Ramps
REDUCE-IT Interim Analysis in Sep/Oct’16 is the Focal Point
{Sorry guys, something weird is happening and i can't upload via googledocs. Below is the update of Boris from SunTrust}
What's Incremental To Our View
We maintained our ‘16E sales/EPS at $121.6M/-$0.34 vs. Street’s $121.5M/- $0.53 vs. AMRN’s $112M-$125M range. The ANCHOR/JELIS promotion & formulary access [200M lives: >140M at Tier II] are contributing to sequential growth. AMRN+Kowa are focused on top-decile prescribers with >70% new patient starts & <30% switches. The REDUCE-IT pre-specified interim analysis is on track for Sept./Oct., with publication of the trial design in the near-term. AMRN exited 2Q16 with $72.5M in cash & expects to turn cash flow (+) in ’17(ex-REDUCE-IT related expenses). Reiterate our Buy/$6PT, supported by DCF.
‘16 sales & LPS unchanged, as Vascepa growth continues to ramp
AMRN raised its 2016 net product sales range to $112M-$125M (from $105M- $120M) with midpoint at $118.5M vs. our/Street’s total revenue of $121.6M/ $121.5M (which includes ~$2M+ in-licensing revenue from recognition of the $15M upfront from Eddingpharm [private] amortized over 16 years). Our model assumes ’16 Vascepa sales ramp sequentially given AMRN & Kowa Pharma (private) sales forces rolled out their respective JELIS promotional efforts in 4Q15 (Nov.) & 2Q16 (Feb), respectively. As of June 30, AMRN exited 2Q16 with cash & cash equivalents of $72.5M (vs. $107M as of YE15) and continues to expect to be positioned to enter 2017 cash flow positive from commercial operations, excluding REDUCE-IT and other related R&D expenses not required to sustain current commercial operations. The next catalyst is the REDUCE-IT interim analysis that’s on track for Sept./Oct. ’16. We expect AMRN and its lead investigators to publish a REDUCE-IT trial design paper in the near term (possibly NEJM). We reiterate our Buy/$6PT, which is based on DCF analysis.
Vascepa’s posting consecutive quarters of >50% TRx growth YoY
2Q16 adjusted TRx for Vascepa, per IMS, grew +14% QoQ & +53% YoY, marking the tenth consecutive quarter with TRx YoY growth of more than 50%, as ANCHOR and JELIS promotions start to kick-in. AMRN complemented its volume growth with a +6% Vascepa price increase (PI) on Dec. 31, 2015 & June 1, 2015 increase of +6%. AMRN & partner Kowa’s commercial strategy is focused on the top-decile high-prescribing physicians. AMRN has detailed two-thirds of its 20K high-prescribing specialists with a frequency of ~4.5 times (you need a frequency of 6+ to generate meaningful sales). Kowa is targeting 50K high prescribing physicians, but has seen them >2 times since implementing the JELIS promotion in February ’16. Vascepa accounts for ~20% of the prescription omega-3 market, suggesting room for further upside, with NRx’s >20% and >30% from targeted physicians. AMRN is also positioned to benefit from the FDA’s label change to fenofibrates (click here), contributing to a -5% decline in the >21M TRx’s written in 2015. The bulk of Vascepa TRx (70%-80%) is for new patient starts, while a smaller portion (20%-30%) represents switches. However, we note that a fraction of patients previously treated with fenofibrates/Lovaza prescriptions that are now taking Vascepa and being considered new to brand & not captured in switches, making the switch prescriptions look artificially low, according to AMRN. Vascepa’s managed care access has >140M patients covered at Tier II (low copay) formulary status [total of 200M lives under coverage]. AMRN is in formulary discussions for 2017 access. We assume the negotiations lead to a modest incremental gain in coverage for Vascepa. The MARINE (in females) & ANCHOR (>70% diabetic patient) sub-analysis provide meaningful datasets to help with promotion & drive TRx growth. We model $119.6M in 2016 Vascepa sales, +48% up YoY.
REDUCE-IT pre-specified interim efficacy analysis in Sept/Oct 2016
The most important catalyst for AMRN is the outcome of AMRN’s REDUCE-IT trial, since it could lead to a meaningful expansion of its label and commercial opportunity in patients with high triglycerides who are on statins. AMRN announced a few amendments to the trial protocol, 1) finalizing details of the statistical analysis planning 2) added a second pre-specified interim efficacy analysis at approximately 80% of the 1,612 primary events and 3) expanded to over 30 pre-specified secondary & tertiary endpoints to measure a broader array of potential clinical effects. Amarin remains blinded to the interim analysis & ongoing results of the REDUCE-IT study until after the study is stopped at either the interim analysis or at the final analysis. The REDUCE-IT trial design is modeled after nine previous outcomes trials for statins. We believe that Amarin will showcase the REDUCE-IT trial design in a peer-reviewed scientific journal [possibly the New England Journal of Medicine (NEJM)] over the next few months. AMRN indicated that the timing of the publication will depend on the trial’s Principal Investigators and journal peer review. Given the nature of outcome study and the design of REDUCE-IT, Amarin expects the DMC to recommend that REDUCE-IT continues until it attainment of 100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of results in 2018. However, it is possible that the trial could be stopped early, if Vascepa is highly statistically significant vs. placebo on the primary endpoint at the interim looks (p-value must be <0.0076 at the 60% interim look, & <0.022 at the 80% interim look), as well as showing robust efficacy on “certain secondary outcome measures”. The REDUCE-IT trial is expected to conclude & have final data published with a sNDA submission in 2018E. AMRN indicated on its 2Q16 earnings call that if REDUCE-IT meets its study goals in Sept/Oct ’16, the company will likely need to raise capital to support the commercialization of the indication expansion and/or consider its partnership options especially after the Kowa agreement is set to expire in 2018.
Page
Thanks HD
Scripts Update for Week Ending 29/07
V
TRx: 16,389 {vs 16,795; -2.42%} Sector +0.20%
NRx: 6,502 {vs 6,693; -2.85%} Sector -0.42%
Ref: 9,887 {vs 10,102; -2.13%} Sector +0.58%
L
TRx: 2,236 {vs 2,051; +9.02%}
NRx: 835 {vs 814; +2.58%}
GenL
TRx: 58,954 {vs 58,575; +0.65%}
NRx: 21,690 {vs 21,642; +0.22%}
V TRx Market Share: 21.13% vs 21.69%
V NRx Market Share: 22.40% vs 22.96%
V Ref Market Share: 20.36% vs 20.93%
Pyrr
You're back in the red as price is now @ 3.29...i hope you closed your 3.27 short position and not added to it as you mentioned earlier.
This will be a one way train, you better be on board
SunTrust 2Q16 Initial Thoughts: Sales & EPS Beat;’16 Revenue Range Raised to $112M-$125M REDUCE-IT Interim is the Focal Point as Vascepa Revenue Ramps BUY
2Q16E Sales/EPS of $33.1M/(-$0.09) Beat Our/Street Estimates
2Q16 net revenues were $33.1M, +$3.8M above the Street & +$2.9M above our estimates on Vascepa sales at $32.8M (+$3.1M/+$5.0M). LPS of -$0.09 beat the Street/our estimates by +$0.04/+$0.02 on other income related to a gain on the derivative liability (+$0.03) and higher sales (+$0.01). The addition of the ANCHOR & JELIS messaging into the promotional cycle along with a 5% decline in the >21M TRx written for fenofibrates is contributing to Vascepa growth. Our model assumes Vascepa sales ramp in 2H16 and is aligned with AMRN’s new ’16 revenue range of $112M-$125M (from $105M-$120M) vs. our $121.6M estimate. The next expected catalyst for AMRN is the REDUCEIT interim analysis that is on track for Sept./Oct. ’16. We expect AMRN and its lead investigators to publish a REDUCE-IT trial design paper in the near term. REDUCE-IT has the potential, in our opinion, to be a game-changer in Vascepa’s life cycle, since it could lead to a meaningful expansion of Vascepa’s label and commercial opportunity in patients with elevated triglycerides who are on statins. A pre-specified interim analysis of the REDUCE-IT results is on track for Sept/Oct, representing the first look at the un-blinded efficacy study by its Data Monitoring Committee. AMRN indicated on the call that if REDUCEIT is successful, AMRN would consider expanding its sales force & evaluate its partnership options in parallel with the expiration of the KOWA agreement in 2018. AMRN is on track to be cash flow positive (excluding R&D & related costs) in ‘17E. As of June 30, AMRN exited 2Q16 with cash & CE of $72.5M (vs. $107M as of YE15) vs. our $62.3M estimate.
REDUCE-IT protocol updated under SPA, in conjunction with FDA
AMRN announced a few amendments to the trial protocol, 1) finalizing details of the statistical analysis planning 2) added a second pre-specified interim efficacy analysis at approximately 80% of the 1,612 primary events and 3) expanded to over 30 pre-specified secondary & tertiary endpoints to measure a broader array of potential clinical effects. Amarin remains blinded to the interim analysis & ongoing results of the REDUCE-IT study until after the study is stopped at either the interim analysis or at the final analysis. The REDUCE-IT trial design is modeled after nine previous outcomes trials for statins. We expect Amarin to showcase its REDUCE-IT trial design in a peer-reviewed scientific journal (NCT01492361) over the next few months. Given the nature of outcome studies and the design of REDUCE-IT, Amarin expects the DMC to recommend that REDUCE-IT continues until it attainment of 100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of results in 2018. However, it is possible that the trial could be stopped early, if Vascepa is highly statistically significant vs. placebo on the primary endpoint at the interim looks (p-value must be <0.0076 at the 60% interim look, & <0.022 at the 80% interim look as well as showing robust efficacy on “certain secondary outcome measures”. The REDUCE-IT trial is expected to conclude & have final data published, with an sNDA submission in 2018E.
‘16E revenue raised to $112M-$125M vs. our $122M est.
AMRN raised its 2016 sales range to $112M-$125M (from $105M-$120M) with midpoint at $118.5M vs. our $121.6M estimate. AMRN expects continued Vascepa total prescription (TRx) growth to drive its increased full-year revenue despite the potential impact of periodic fluctuations in wholesaler inventory levels. AMRN continues to expect to be positioned to enter 2017 cash flow positive from commercial operations, excluding REDUCE-IT and other related R&D expenses not required to sustain current commercial operations.
2Q16 sales of $33.1M was +$3M/+$4M above our/Street est’s.
2Q16 total sales were $33.1M (+87% YoY), +$2.9M/+$3.8M above our/Street’s $30.2M/$29.3M. Total revenue included Vascepa revenue of $32.8M (vs. our/Street’s $29.7M/$27.8M) and licensing revenue of $0.3M (vs. our $0.5M) from its Vascepa partnership in China where the product was allowed to move into the clinical phase of development by the China sFDA. 2Q16 adjusted TRx for Vascepa, per IMS, grew +14% QoQ & 53% YoY as ANCHOR and JELIS promotion continues to kick-in. AMRN complemented its volume growth with a +6% Vascepa price increase (PI) on Dec. 31, 2015 & June 1, 2015 increase of +6%. Vascepa represents ~20% of the prescription omega-3 market, suggesting room for further upside. AMRN is ideally positioned, in our view, to benefit from the FDA’s label change to fenofibrates, contributing to a -5% decline in the >21M TRx’s written in 2015. In addition, Vascepa should also benefit from expanded managed care access, which improved to >140M patients covered at Tier II (low copay) formulary status [total of 200M lives under coverage]. As of June 30, AMRN had cash and equivalents of $72.5M (compared to $107.0M at YE16) vs. our assumption of $62.3M. If REDUCE-IT meets its study goals in Sept/Oct ’16, AMRN will likely need to raise cash to support the commercialization of the indication expansion and/or consider its partnership options especially after the KOWA agreement is set to expire in 2018.
2Q16 AMRN P&L review
Total revenue came in at $33.1M in 2Q16, up +87% YoY vs. our/Street’s estimate of $30.2M/$29.3M. Gross margin was 73.2%, which was +28bps higher than our estimate of 73.0% but -202bps lower compared to Street’s 75.3% estimate as its benefits from high volume and lower API cost. R&D expense came in at $12.1M vs. our/Street’s $10.9M/$12.8M. SG&A expense in the quarter was $23.2M, below our $25.7M & the Street’s $27.1M. A higher tax benefit ($1.0M tax benefit vs. our/Street’s $0.4M/$0.2M tax benefit) & a modest benefit from other income (+$0.2M other income vs. our estimate of +$0.0M), resulted in a 2Q16 loss of (-$0.09) vs. our/Street’s loss per share of (-$0.11)/(-$0.13).
Just a humble opinion;
Regarding today's 80% 2nd interim announcement.
I would take that as the ultimate and perfect short trap :):) again just an opinion
With this announcement now all shorts are on fire, saying no halt in 90 days and its a do or die at the 2nd....bla bla bla
This makes the short squeeze scenario at best
Now with this announcement they feel safe and that if management believed in halt at the 1st interim, they wouldn't have added this 2nd one. (i know i know guys, it has way more to do with new endpoints, making the final reading smoother....etc), but let them keep on thinking like that
Coming September, October at most and the halt will surely shock them all and that will be the perfect scenario for one of the greatest squeezes :)
Good luck to all, but be sure i won't feel pity, sadness or whatever emotion a human being might have for shorts burning now, in the future or at any time :)
all hail Einstein of bio Pyrrr
Amarin reported cash and cash equivalents of $72.5 million at June 30, 2016
EPS BEAT --- Under GAAP, Amarin reported or basic and diluted loss per share of $0.07
Gross margin on product sales improved to 73% in the three and six months ended June 30, 2016 as compared to 64% in the three and six months ended June 30, 2015
Net product revenue for the three months ended June 30, 2016 and 2015 was $32.8 million and $17.7 million
Amarin is increasing its guidance estimate for total 2016 net product revenue to $112 million to $125 million.
Statins may RAISE the chances of diabetes: Cholesterol-lowering pills increase the likelihood of the condition - but doctors say the benefits 'outweigh the risks
Statins lower 'bad' cholesterol in order to protect against heart disease
But lowering bad cholesterol levels may increase the risk of diabetes
Scientists said guidelines should not change as benefits outweigh risks
Study revealed boosting 'good' cholesterol may protect against diabetes
Statins, which lower the 'bad' form of cholesterol, could increase the risk of diabetes, a study suggests.
Scientists found that people with naturally lower levels of low-density lipoprotein (LDL) cholesterol were less likely to develop heart disease.
But they were slightly more vulnerable to type 2 diabetes.
As statins reduce LDL levels they will have the same effect, they believe.
They also found boosting levels of 'good' cholesterol may protect against type 2 diabetes - meaning one day this could prevent or treat the condition.
Statins, which lower the 'bad' form of cholesterol, could increase the risk of diabetes, a study suggests.
Scientists found that people with naturally lower levels of low-density lipoprotein (LDL) cholesterol were less likely to develop heart disease.
But they were slightly more vulnerable to type 2 diabetes.
As statins reduce LDL levels they will have the same effect, they believe.
They also found boosting levels of 'good' cholesterol may protect against type 2 diabetes - meaning one day this could prevent or treat the condition.
Lead researcher Dr Michael Holmes, from Oxford University, said: 'What we've shown in this study is that the role played by blood lipid levels in disease is a complex one.
'While the effect of taking LDL cholesterol-lowering drugs such as statins may slightly increase a person's risk of developing diabetes this effect is greatly outweighed by their benefits in the form of preventing people from suffering from a life-altering heart attack or stroke.'
Scientists do not know exactly why having lower levels of LDL cholesterol increases the risk of type 2 diabetes.
One theory is that the drugs raise a person's resistance to insulin, the hormone that takes sugar out of the blood.
Another is that the drugs impair the pancreas' ability to secrete insulin.
Dr Holmes said the team also found raising levels of 'good' high-density lipoprotein might protect against type 2 diabetes.
And this may not result in lowering of heart disease risk as observational studies have suggested, he added.
This means drugs that increase HDL cholesterol could be developed to treat and prevent diabetes.
The team analysed large data sets of information about genetic make-up to tease apart the possible effects on heart disease and diabetes risk of LDL and HDL (which is thought to protect against disease).
They also looked at the influence of triglyceride blood fats which are associated with heart disease.
Cases of heart disease were more likely to occur among people with genetic mutations that increased their levels of LDL or triglycerides, the research showed.
But genetic variants that raised either LDL or HDL cholesterol levels, and possibly triglyceride levels, slightly reduced the chances of developing type 2 diabetes.
The findings may help explain why previous studies have shown a modest increase in diabetes risk among patients taking statins.
Because of the proven benefits of statins, clinical guidelines on prescribing the drugs should not change, said the scientists.
Professor Jeremy Pearson, from the British Heart Foundation, which funded the research, said: 'This carefully conducted large-scale genetic study reports several novel and interesting results on the relationships between levels of different blood lipids and the risk of developing heart disease or diabetes.
'One key finding is that patients with naturally lower LDL cholesterol levels, similar to those taking a statin, have a slightly increased risk of diabetes, indicating that the risk is related to LDL levels and not to any separate effect of the statin itself.
The study was published in the journal JAMA Cardiology.
THE SOARING COST OF DIABETES: NHS SPENDING NEARLY DOUBLES TO ALMOST A BILLION IN A DECADE
Spending on diabetes prescriptions has nearly doubled in a decade, a report has revealed.
The NHS spent £956.7 million on insulin, antidiabetic drugs and diagnostic and monitoring services - such as machines to test blood sugar - in 2015/16.
This is an 86 per cent increase since 2005/06, when £513.9 million was spent on the same treatments for the disease, official figures show.
In fact, diabetes drugs now make up more than 10 per cent of the total cost of prescriptions in primary care.
Since 2007/08, they have accounted for the highest cost of any group of medicines prescribed.
The alarming figures, released today by the Health and Social Care Information Centre, reveal the ballooning cost of this disease – with health bodies warning the burden is certain to increase.
PUBLISHED: 15:00 GMT, 3 August 2016 | UPDATED: 21:28 GMT, 3 August 2016
Link:
http://www.dailymail.co.uk/health/article-3721850/Statins-RAISE-risk-diabetes-Cholesterol-lowering-pills-increase-chances-condition-benefits-heart-outweigh-risk.html
I posted the below earlier today, and things are moving as predicted....
Is tmw the KBOOOOMMMM day, let's wait and see. Gap will be closed all the way up to 4.8, as it seems it will be way sooner than later
Again, I'd be extremely worried the coming 48hrs if I'm holding a short position
"humble opinion: its been a great run the last 3 days. In my opinion, we will see today a huge volume once again and we will test the 3.33 level (will be breached or not, i have no idea frankly), but I think that we will close around this 3.33 level and tmw morning with the earning and CC (and maybe some announcement, as always retail to hear last), we will shoot high, surpass it and the gap closing will be fully in motion, The building for this gap close might be confirmed in today's trading, let's wait and see.
Again, just an opinion and a feeling. Something is in the making since we are having this run with no news at all
If i am a long-timer short or a new one, id be really worried to be short this stock in the coming 48-72 hrs"
Raf 78117 it shows in the attachment of FFS
He is legit, don't worry :):)
posted: Monday, 04/18/16 08:22:38 PM
Short volume reached 66% of yesterday trading as per shortanalytics and shortvolume data
Those shorts will never learn !!!
A humble opinion: its been a great run the last 3 days. In my opinion, we will see today a huge volume once again and we will test the 3.33 level (will be breached or not, i have no idea frankly), but I think that we will close around this 3.33 level and tmw morning with the earning and CC (and maybe some announcement, as always retail to hear last), we will shoot high, surpass it and the gap closing will be fully in motion, The building for this gap close might be confirmed in today's trading, let's wait and see.
Again, just an opinion and a feeling. Something is in the making since we are having this run with no news at all
If i am a long-timer short or a new one, id be really worried to be short this stock in the coming 48-72 hrs
So many new names the past few days, most from yahoo board where it was mostly bashing with no valid arguments to back the mentioned points.
We welcome all newbies on the board, but please, a personal begging, don't insult my brain/mind and others. We've been here for years, most believe in the science, and few random board msgs or 24 msg to be accurate won't work.
The science that's been provided on this board ( we have zum) to thank for that in addition to various discussions based on real life experience (JL , avii, hd, to name a few, no disrespect to others) would take you several month to go through all
So again, please, the scare tactics won't work on this board, save ur fingers and nerves...and f&$@ ur sponsors, I can put u on the payroll of my firm and by that would be helping you and mostly my fellow board members
Cheers and I love the smell of shorts frying (sorry FFS for stealing ur line)?:):):)
Btw, where is MOGGYYY, damn I bet he's fired by now, shameeeee
SunTrusy Contd (Sorry not able to attach the research)
statins. REDUCE-IT reached target enrollment of approximately 8,000 patients and the onset of
approximately 60% of the target aggregate number of primary cardiovascular events within the study
has triggered preparation for a protocol pre-specified interim efficacy analysis by the independent Data
Monitoring Committee (DMC) expected to be conducted in September or October 2016. The pending
interim analysis in late 3Q16/early 4Q16 represents the first review of unblinded efficacy data by the
DMC. Amarin remains blinded to the interim and ongoing results of the REDUCE-IT study until after
the study is ready to be stopped either at the interim analysis or at the final analysis. The REDUCE-IT
trial design is modeled after nine previous outcomes trials for statins. We expect Amarin to showcase
its REDUCE-IT trial design in a peer-reviewed scientific journal over the next few months (https://
clinicaltrials.gov/ct2/show/NCT01492361). Given the nature of outcomes studies and the design of
REDUCE-IT, Amarin expects the DMC recommends that REDUCE-IT continue until attainment of
100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of
results in 2018. The REDUCE-IT trial is expected to conclude and have final data published & potential
sNDA submission in 2018. Amarin believes a successful REDUCE-IT result would enable Vascepa
to capture a larger share of the 25M annual prescriptions written for other triglyceride-lowering nonstatin
agents such as fibrates & prescription niacin.
SunTrust 2Q16 Preview – REDUCE-IT Interim is the Focal Point as Vascepa Revenue Ramps
Vascepa+53% YoY / +14% QoQ TRx growth; REDUCE-IT Interim analysis in Sep/Oct‘16
What's Incremental To Our View
We maintained 2Q16E sales at $30.2M vs. Street’s $29.3M & LPS at(-$0.11)
vs. Street’s(-$0.13). Our 2Q Vascepa sales are $29.7M(+68% YoY; +53%
TRx’s+6% price) as ANCHOR/JELIS promotions ramp. Vascepa had 5 fewer
wholesaler days in 1Q16, implying +$1.6M upside to our 2Q est. Our FY16E
sales/LPS is $121.6M/(-$0.34) vs. AMRN’s $105M-$120M range & Street’s
$121.5M/(-$0.53). REDUCE-IT results needed to expand Vascepa market
oppy, with the event rate tracking to plan & triggering a pre-specified interimanalysis
in Sep/Oct’16 by its Data Monitoring Committee. Reiterate Buy/$6PT,
supported by DCF.
2Q16E sales above at $30.2M & LPS (-$0.11) vs. Street’s $29.3M/(-$0.13)
We maintained our 2Q16E sales at $30.2M vs. the Street’s $29.3M based on
Vascepa’s quarterly total prescription trends (TRx growth +53% YoY [+14%
QoQ] & +6% price increase over the last 12 months). We model gross profit
at 73.0% vs. the Street’s 75.3%. We model a lower operating loss of -$14.5M
vs. the Street’s -$19.0M, yielding an LPS of -$0.11 vs. Street’s -$0.13. AMRN
indicated on its 1Q16 call (click here for note) that Vascepa had five fewer
days of wholesaler access in 1Q16, which implies +$1.6M potential upside to
our Vascepa sales estimate. AMRN had also indicated that in April, the FDA
removed the label of all fenofibrates & prescription niacin drugs (and associated
combo drugs) used in combination with statins for reducing triglycerides due to
a failed outcomes study (click here). Vascepa currently represents only ~20%
of the prescription omega-3 market, suggesting potential for further upside.
Vascepa’s managed care access improved with >140M patients covered at
Tier II (low copay) formulary status [total of 200M lives under coverage]. Our
model assumes 2016 Vascepa sales ramp sequentially given AMRN & Kowa
Pharma(private) sales forces rolled out their respective JELIS promotional
efforts in 4Q15 (Dec) & 1Q16 (Feb). The addition of the ANCHOR & JELIS
data in the promotional cycle is helping to drive robust TRx growth in 2016, with
Vascepa sales ramping throughout 2016. We model $119.6M (+48% YoY) in
2016 Vascepa sales, compared to Street’s $116.0M.
REDUCE-IT pre-specified interim efficacy analysis in Sept/Oct 2016
The next most important catalyst for AMRN is the outcome of AMRN’s
REDUCE-IT trial. REDUCE-IT has the potential to be a game-changer in the
Vascepa life cycle, since it could lead to a meaningful expansion of Vascepa’s
label and commercial opportunity in patients with high triglycerides who are on
Scripts Update -- ATH Across the Board Market Share
Week Ending 22/07
V
TRx: 16,795 {vs 16,499; +1.79%} Sector -2.20% --- ATH
NRx: 6,693 {vs 6,330; +5.73%} Sector -1.62% --- ATH
Ref: 10,102 {vs 10,169; -0.66%} Sector -2.55% -- (ATH = 10,169)
L
TRx: 2,051 {vs 2,174; -5.66%}
NRx: 814 {vs 929; -12.38%}
GenL
TRx: 58,575 {vs 60,488; -3.16%}
NRx: 21,642 {vs 22,369; -3.25%}
V TRx Market Share: 21.69% vs 20.84% --- ATH
V NRx Market Share: 22.96% vs 21.36% --- ATH
V Ref Market Share: 20.93% vs 20.53% --- ATH
Scripts Update for Week Ending 15/07
V
TRx: 16,499 {vs 15,548; +6.12%} Sector +5.92%
NRx: 6,330 {vs 5,669; +11.66%} Sector +12.73%
Ref: 10,169 {vs 9,879; +2.94%} Sector +2.22% -- ATH
L
TRx: 2,174 {vs 2,123; +2.40%}
NRx: 929 {vs 827; +12.33%}
GenL
TRx: 60,488 {vs 57,069; +5.99%}
NRx: 22,369 {vs 19,786; +13.05%}
V TRx Market Share: 20.84% vs 20.80% -- = to ATH
V NRx Market Share: 21.36% vs 21.57% {ATH = 22.07%}
V Ref Market Share: 20.53% vs 20.39% -- ATH
H1-2016 vs. H1-2015 (Retail + Institutional Data)
V
TRx H1-2016 vs H1-2015 +53.51% – Sector +2.09%
L
TRx H1-2016 vs H1-2015 -61.39%
Gen L
TRx H1-2016 vs H1-2015 +4.53%
Q2-2016 vs. Q1-2016 (Retail + Institutional Data)
V
TRx: 215,355 {vs 187,231; +15.02%} – Sector +1.09%
L
TRx: 44,965 {vs 61,632; -27.04%}
Gen L
TRx: 863,196 {vs 862,586; +0.07%}