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I agree with you I feel that there is a vast dichotomy in our value pre and post SNDA labelling...
Intriguing study, sounds like Vascepa can be a panacea drug...
I agree, just had one recently with JL too, He is just too high and mighty, regardless of his time here on the board....
Give it to him good
I like it. Thanks
Heard some rumors that you guys are looking to buy out Amarin. Anyone heard that....
Only thing I could imagine is since insiders own tons of shares their proceeds would be astronomical....
Very interesting a possibility...
Thanks Nuke ...LOL
Thanks, since i'm fairly new, I did not know..grain of salt or pepper I guess, I've dealt with some pompous doctors in 40 years...
None needed have a great day
Thanks you....
Since on V, I've noticed some increased mental acuity, also decreased swelling and pain in my damaged knuckle
I think institutional buy with 5 million shares the first hour
That's Funny, I help my wife and she makes 6 figures yearly.
I appreciate your frankness, but I'll leave it there, As you know Real Estate is not as easy as people think, its not all about showing homes, especially here in Florida, we do all the work very rare for lawyers to come into play..
LOL, if I had more credential I'd use em
Great points...
What makes you so relevant?
Maybe you should do some plastic surgery on the mouth of yours and shut it Mr high and mighty md
Be Careful with Johnny come lately statement.
As you say we are entitled to our own opinions. I was a RPH for 40 years and I did quite a bit of compounding when it was in the norm.
I am not denigrating the company, but they have 1 drug which is a massive success to the world and to shareholders. If they do not have proper marketing and external help getting the work out properly it could take more time than necessary to achieve all of the goals that they eschew.
I take offense with the Johnny come lately comment, Ive owned this stock for 7 years when I originally paid $15 seeing it decline to chump change.. I was not aware of this site till recently..
BTW
I am also a Zoologist by education, Professional Photographer and now a Real Estate agent.. And I owned 2 Pharmacies in New York..
Ill accept your apology in advance..
LOL
This is why are partner is required to straighten out some of their decision strategies. It should be a no brainer as you correctly state. My concerns are as to who is advising them. Hope that it’s not Jeffries.
Massulo RPH.
That's all fantastic, but IMO Amarin is not big enough to handle this octopus of a drug and its derivatives...
yes.. yes
BTW
I am only taking 1gm BID and seeing these results..on pain
Will take blood soon to see results on trigs that were 323
I also have a spur in there..Twas a golfing accident...
I read the article. Very intriguing in that this converted form increases epa to cross the bbb to further enrich the neurons with epa.
Don’t know
I have a damaged knuckle for 7 years it’s 20% larger than in other hand. Since on v for 4 months the swelling is down and pain just about gone
5 Articles Today --- To The Moon AMRN
What Are Analysts Recommending for Amarin in January?
By Margaret Patrick2 hours ago
Stock price movements
On January 7, Amarin (AMRN) closed at $14.07, 6.59% higher than its previous closing price. On January 4, Amarin issued a press release announcing preliminary results for fiscal 2018 and guidance for fiscal 2019. According to the press release, the company had cash, net accounts receivable, and inventory of $249 million, $72 million, and $56 million, respectively, on its balance sheet.
According to the press release, the company has expanded its sales force in the US to 400 people for fiscal 2019. The company aims to deploy these resources to aggressively promote Vascepa and educate the physician community about the merits of the drug. After this announcement, Amarin rose 4.68% from $12.61 on January 3 to $13.20 on January 4. Based on its closing price on January 7, the company reported returns of 6.27% in the last week, -16.99% in the last month, and -30.66% in the last quarter. Amarin also reported returns of 372.15% in the last half year, 235.80% in the last year, and 3.38% YTD.
Graph 1
On the other hand, based on its closing price on January 7, the broader market represented by the SPDR S&P 500 ETF (SPY) reported returns of 2.68% in the last week, -5.87% in the last month, and -12.11% in the last quarter. The SPDR S&P 500 ETF also reported returns of -7.64% in the last half year, -6.34% in the last year, and 1.78% YTD.
Analysts’ recommendations and target price for Amarin
The 12-month consensus analyst recommendation for Amarin on January 8 is a “buy.” The 12-month consensus target price for the company is $30.20, which is 114.64% higher than its last closing price on January 7. The highest target price estimate for the company is $51, and the lowest target price estimate is $15.
Out of the five analysts covering Amarin on January 8, two analysts have rated the company as “strong buy,” and three analysts have rated the company as a “buy.”
In the next article, we’ll discuss revenue projections for Amarin in greater detail.
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Amarin Expects Robust Revenue Growth Going Forward
By Margaret Patrick2 hours ago
Revenue guidance
In a press release issued on January 4, Amarin (AMRN) projected net total revenues in the range of $224 million to $228 million for fiscal 2018, which is a YoY rise of 24% to 26%, or $43 million to $47 million. The company has also forecasted net total revenues of $72 million to $76 million for the fourth quarter of 2018.
According to the press release, the majority of the revenue rise in fiscal 2018 was thanks to increased demand for Vascepa in the US market, while less than $1.0 million in revenues have been earned from ex-US markets. The company says inventory levels of Vascepa with wholesalers are in the normal industry range at the end of fiscal 2018.
Graph 2
According to the press release, Amarin expects its net total revenues to be around $350 million for fiscal 2019, a YoY rise of over 50%. The company plans to leverage the robust results from the cardiovascular outcomes study, REDUCE-IT, to further increase adoption of Vascepa in fiscal 2019. The company, however, doesn’t expect dramatic changes in managed care coverage for Vascepa in 2019 as compared to 2018.
Wall Street estimates
Wall Street analysts expect Amarin to report revenues of $220.60 million in fiscal 2018, a YoY rise of 21.81%. The company is also expected to report revenues of $370.03 million in fiscal 2019, a YoY rise of 67.74%. Wall Street analysts have forecasted Amarin’s fiscal 2020 revenues to be $573.23 million, a YoY rise of 54.92%. Wall Street analysts have projected Amarin’s revenues to be close to $68.68 million in the fourth quarter of 2018, a YoY rise of 27.49%.
In the next article, we’ll discuss the earnings growth prospects of Amarin in greater detail.
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Amarin Is Expected to Become Profitable in Fiscal 2020
By Margaret Patrick2 hours ago
Label expansion in fiscal 2019
In a press release issued on January 4, Amarin (AMRN) announced that it will be submitting a supplemental new drug application (or sNDA) to the FDA in fiscal 2019, seeking inclusion of cardioprotective benefits as demonstrated in the REDUCE-IT trial in Vascepa’s label.
According to Amarin’s investor presentation, Vascepa is currently approved by the FDA to treat patients with triglyceride levels in excess of 500mg/dL. Results from the REDUCE-IT trial demonstrated Vascepa’s efficacy in reducing the cardiovascular risk for patients independent of their triglyceride levels.
Graph 3
According to the company’s investor presentation, Vascepa demonstrated 25% relative risk reduction (or RRR) in major adverse cardiovascular events (or MACE) and 20% RRR in cardiovascular death when administered to patients on top of statin therapy. Vascepa also demonstrated a 28% RRR drop in strokes and 31% RRR drop in heart attack on top of statin therapy. The company also plans to leverage data from the REDUCE-IT trial to secure regulatory approvals in ex-US markets.
Wall Street estimates
Wall Street analysts expect Amarin to report a non-GAAP loss per share of $0.37 in fiscal 2018, a YoY deterioration of 46.60%. The company is also expected to report a loss per share of $0.10 in fiscal 2019, a YoY improvement of 73.42%. Wall Street analysts have forecasted Amarin’s fiscal 2020 non-GAAP EPS to be $0.27, a YoY improvement of 376.80%.
Analysts have projected Amarin’s loss per share to be close to $0.08 in the fourth quarter of 2018, a YoY deterioration of 1.25%.
In the next article, we’ll discuss the cost structure of Amarin in greater detail.
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Amarin Expects Expenses to Rise in the Future
By Margaret Patrick2 hours ago
Vascepa adoption trends
Amarin (AMRN) expects Vascepa to witness robust demand trends in fiscal 2019 driven by demonstrated efficacy of the drug coupled with the company’s increasing focus on creating awareness for the drug in the healthcare community.
According to the Centre for Evidence-Based Medicine (or CEBM), “The Number Needed to Treat (NNT) is the number of patients you need to treat to prevent one additional bad outcome (death, stroke, etc.).” According to Amarin’s investor presentation, a low NNT of 21 and an affordable price will likely drive managed care coverage for Vascepa in future years. The NNT of Vascepa compares favorably with that of other cardiovascular drugs such as Pfizer’s (PFE) Lipitor and Amgen’s (AMGN) Repatha, which is 45 and 67, respectively.
Graph 4Expense projections
Wall Street analysts expect Amarin to report selling, general, and administrative (or SG&A) expenses of $213.58 million in fiscal 2018, a YoY rise of 17.54%. The company is expected to report SG&A expenses of $276.68 million in fiscal 2019, a YoY rise of 29.55%. The rise is mainly attributable to the rapid expansion of the company’s Salesforce by 400 people for fiscal 2019. Wall Street analysts have forecasted Amarin’s fiscal 2020 SG&A expenses to be $315.80 million, a YoY rise of 14.14%.
Analysts expect Amarin to post research and development (or R&D) expenses of $55.48 million in fiscal 2018, a YoY rise of 17.64%. The company is also expected to report R&D expenses of $43.15 million in fiscal 2019, a YoY drop of 22.22%. Amarin’s fiscal 2020 R&D expenses are expected to be $32.03 million, a YoY drop of 25.78%.
Analysts have projected Amarin’s SG&A and R&D expenses to be close to $68.35 million and $11.87 million in the fourth quarter of 2018, a YoY change of 46.64% and -0.60%, respectively.
Unreal, it shoulda been like this since reduce-it results..PPs would have been much higher,,
You know why.. JPM conference, and the PPs is down....
Some excerpts from the commentary of the new Sa article.. If this is valid
dawgpac68
Comments44 | + Follow
Great, detailed article. Regarding your comments on Amarin's partner, Mochida:
"When I met with Mochida last month, they were very tight-lipped about what exactly their alliance with Amarin will entail but did mention that they would be selling Amarin a compound that allows for quicker absorption of EPA in the bloodstream (Mochida already received a $2.5m milestone payment from Amarin for this in 2018)."
Mochida mentioned in their last quarterly presentation that a "new EPA formulation" was part of their agreement for new R&D with Amarin. This likely refers to MND-2119 which Mochida currently is testing in a Phase 3 trial in Japan against it's own Epadel. If successful, this will likely give Amarin yet another blockbuster before Teva goes generic with Vascepa in 2029.
08 Jan 2019, 02:22 PM
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Motorhead, Contributor
Comments184 | + Follow
Author’s reply »
@dawgpac68
Very good point you've raised and I didn't have time to go into much detail on the Mochida/Amarin relationship because there's so much secrecy around it. But it seems interesting, especially in light of Vascepa's patent expiry in 2030:
1) Mochida's MND-2119 is a new version of Epadel (the Vascepa of Japan that's been on sale since 1990), and its new features will be to allow patients to (a) take the pills on an empty stomach (instead of after meals under current guidance); and (b) take only one dose per day, instead of twice a day currently.
2) Have no idea what it means, but the only thing Mochida told me was that their R&D alliance with Amarin is partly aimed to allow Vascepa to still maintain share after it goes off patent in 2030. This may have something to do with this MND-2119 new type of Epadel.
Given how far ahead Amarin is on the "on-top-of-statin" research front with their Vascepa treatment, the chemical compound they're buying from Mochida now (which allows for faster absorption of EPA into the bloodstream), is the first step in assuring Vascepa dominates the on-top-of-statin market. Mochida's IP will help. And it's cheap (Amarin only paid $2.5m last year to gain access to Mochida's chemical compound that leads to quicker absorption of EPA into the bloodstreatm).
08 Jan 2019, 03:07 PM
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Novo1111
Comments47 | + Follow
Why is it that this analysis is completely at odds with the market? Could it be that the author here actually did his DD? Great, common sense analytics will win the day. Every 'serious investor will look at this step-by-step comparison and realize what a bargain really is. Hopefully, most will not have to do so in the rear view mirror. Superb analytics, well argued and well written.
Excellent work, send it to JT!!!!LOL
FOUND IN MEDPAGE 0N 1/4
Cardio-Endo Connection 01.04.2019
Comment
Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial - REDUCE-IT
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by Deepak L. Bhatt, MD, MPH, FACC
This Clinical Connection is a collaboration between MedPage Today® and: Medpage Today
Contribution to Literature
The REDUCE-IT trial showed that use of icosapent ethyl 2 g twice daily was superior to placebo in reducing triglycerides (TGs), cardiovascular (CV) events, and CV death among patients with high TGs and either known CV disease or those at high risk for developing it, and who were already on statin therapy with relatively well-controlled low-density lipoprotein (LDL) levels.
Description
The goal of the trial was to assess the safety and benefit of icosapent ethyl compared with placebo in reducing CV events among patients with high TGs.
Study Design
Eligible patients were randomized in a 1:1 fashion to either icosapent ethyl (2 g twice daily with food) (n = 4,089) or matching placebo (n = 4,090). Randomization was stratified by primary vs secondary prevention, use of ezetimibe, and geographic region.
Total number of enrollees: 19,212
Duration of follow-up: 4.9 years
Mean patient age: 64.0 years
Percentage female: 28%
Inclusion Criteria
Age >45 years with established CV disease or age >50 years with diabetes and ≥1 additional risk factor
Fasting TG level from 150-499 mg/dl
LDL cholesterol level from 41 and 100 mg/dl
Stable dose of statin for ≥4 weeks
Exclusion Criteria
Severe heart failure
Active severe liver disease
Glycated hemoglobin level >10.0%
Planned coronary intervention or surgery
History of acute or chronic pancreatitis
Known hypersensitivity to fish, shellfish, or ingredients of icosapent ethyl or placebo
Other Salient Features/Characteristics
Secondary prevention cohort: 70.7%
Ezetimibe use: 6.4%
Moderate- or high-intensity statin: 94%
Diabetes: 59%
Median TG levels at baseline: 216 mg/dl, LDL: 75 mg/dl, high-density lipoprotein: 40 mg/dl, high-sensitivity C-reactive protein: 2.2
Principal Findings
The primary CV outcome of CV death, nonfatal myocardial infarction (MI), stroke, coronary revascularization, or unstable angina, for icosapent ethyl vs placebo, was 17.2% vs 22.0%, hazard ratio 0.75, 95% confidence interval 0.68-0.83; P < 0.0001
Secondary outcomes, for icosapent ethyl vs placebo:
Change in TG levels at 1 year: -39.0 mg/dl vs 4.5 mg/dl
Change in LDL at 1 year: 2 mg/dl vs 7 mg/dl
CV death or MI: 9.6% vs 12.4%, P < 0.001
All MI: 6.1% vs 8.7%, P < 0.001
Revascularization: 5.3% vs 7.8%, P < 0.001
All-cause mortality: 6.7% vs 7.6%, P = not significant
Atrial fibrillation/flutter: 5.3% vs 3.9%
Serious adverse bleeding events: 2.7% vs 2.1%, P = 0.06
Interpretation
The results of this trial indicate that the use of icosapent ethyl 2 g twice daily was superior to placebo in reducing TGs, CV events, and CV death among patients with high TGs and either known CV disease or those at high risk for developing it, and who were already on statin therapy with relatively well-controlled LDL levels. Rates of revascularization and MI were lower, while atrial fibrillation/flutter and bleeding were higher with icosapent ethyl.
These are very interesting findings, and come on the heels of several negative trials with n–3 fatty acid supplementation. One aspect of this medication is that it has a higher dose of purified eicosapentaenoic acid (EPA) (4 g/day) than what was tested in other clinical trials. Other trials with moderate to high doses of t are ongoing. This is one of the first non-LDL targeted trials to show a CV benefit, and will likely be featured in future guidelines.
References
Bhatt DL, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction With Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2018; Nov 10: [Epub ahead of print].
Kastelein JJ, Stroes ES. Editorial: FISHing for the Miracle of Eicosapentaenoic Acid. N Engl J Med 2018; Nov 16: [Epub ahead of print].
Presented by Deepak Bhatt at the American Heart Association Annual Scientific Sessions (AHA 2018), Chicago, IL, November 10, 2018.
There u go, everyone gets V to protect from these lawyers....
1.86 mill shares just sold
Imagine if 2019 Guidance was some what more exciting...
Love your reasoning....
Yea its up 40.81 today
I really think that its bogus, the pts would have told their Md's about it & reported it...IMO
Imagine all of us have to stew over the weekend.....