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Amarin Corporation plc (AMRN)
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SCOTUS took other cases involving biotech issues with patents being knocked down by federal judges - and those cases will apply to AMRN's case one precedent is set and AMRN can sue again. SCOTUS did not have to take every patent issue case - give it time and AMRN has so many other good things happening - I'm holding.
Updated FAQ today
"What is Amarin's plan for operations now that generic versions of icosapent ethyl have launched in the United States? Amarin believes that the generic market for icosapent ethyl (brand name VASCEPA®) in the United States is atypical in two respects: 1) VASCEPA is in the very early stage of launch in its new indication and most healthcare professionals and at-risk patients don’t yet know about VASCEPA (generic companies typically don’t invest in market education or market expansion) and 2) manufacturing of icosapent ethyl is challenging and expensive such that, based on information available to Amarin on the date hereof, generic companies are anticipated to have limited supply capacity and gross margins that are lower than those typical of generic products. Particularly if generic companies have limited supply capacity, it would be unusual for them to sell their limited supply at a low price as it would further strain their gross margins. As a reminder, VASCEPA is not a high-priced drug. In the United States, Amarin plans to continue its robust sales and marketing efforts which keep branded VASCEPA a prioritized area of focus for the company and a significant source of revenue. After generics launch, a portion of revenue from icosapent ethyl sales is expected to go to generic manufacturers. Nevertheless, Amarin plans to continue efforts to grow usage of this important branded therapy seeking an advantageous pace for Amarin in light of the large potential market need and our current anticipation that generic companies have limited ability to supply the market. Increased VASCEPA awareness and increased usage of VASCEPA made possible by Amarin’s commercialization efforts, in an environment of limited availability of generic supply, is expected to benefit both Amarin and the additional at-risk patients who are treated by VASCEPA. Amarin plans to adjust its approach as appropriate to accommodate changes in market dynamics. In Europe, preparations for VASCEPA approval and commercial launch are not impacted by generic icosapent ethyl in the United States (in Europe Amarin is seeking a different indication than has been subject to patent litigation in the United States; see separate FAQ regarding regulatory exclusivity in Europe). In China, advancement of VASCEPA is not impacted by generic icosapent ethyl in the United States. The same is believed to be true in Canada and in various other parts of the world where VASCEPA commercialization is in development and being considered for development. With respect to potential legal remedies in the United States, please see this FAQ for more information. Relating to COVID-19, Amarin continues to progress pilot studies to explore ways in which VASCEPA might be able to improve patient care. And, in commercial promotion due to the impact of COVID-19 restrictions on product awareness and patient care, Amarin continues to work to refine how to best increase awareness and education of VASCEPA, including testing the cost effectiveness of various promotional approaches beyond its baseline activities. Amarin appreciates the various constructive suggestions it has received from shareholders and is committed to provide updates as it progresses. Dated: June 22, 2021"
William's Mom LovesDick
I’m going down with the titanic and I don’t care. I’m in it until the bitter end, no matter what that holds. Far too invested here, I have 131K shares and will not sell it until i see 20.
I know anyone can say #&@ online, right Niall?
Karim, please concentrate on selling the EU market. Get 500 million in sales next 10 months and watch your sp.
Northland analyst Carl Byrnes recommends using today's selloff in shares of Amarin as a buying opportunity. The response to the Supreme Court's decision not to hear an appeal on Vascepa patents related to treating hypertriglyceridemia is an "extreme overreaction," Byrnes tells investors in a research note. The Supreme Court rarely hears patent appeals, and Amarin's patents covering Vascepa's expanded label for reducing persistent cardiovascular risk remain intact and fully enforceable, says the analyst. Byrnes notes that the expanded label represents around 90% of total prescriptions. He keeps an Outperform rating on Amarin with a $15 price target. The stock in morning trading is down 11% to $4.41.
Despite patent loss at Supreme Court, Amarin still a buy
• DA Davidson views yesterday's selloff of Amarin (NASDAQ:AMRN) shares after the Supreme Court declined to revive Vascepa patents as an overreaction.
• Analyst Carl Bynes says that the company's patents for reducing persistent cardiovacular risk remain intact.
The US Supreme Court had a chance to right a wrong but they didn’t want to defend or take a stand on their own procedural guidelines that they’ve asked the lower courts to follow...they just passed.
It was a long shot anyways and nobody really had much faith in the courts doing Amarin any favors anyways...I sure didn’t...was hopeful but definitely didn’t count on it.
Now it’s time to focus on a successful EU launch and China approval.
Launch their own generic Vascepa is the US and continue to defend the CV patents by calling out violations by Hikma and now Dr. Un-Reddy!
All is not lost despite what many want you to believe. Vascepa sales will continue to grow in Amarin’s hands or BP.
The US market for Vascepa is far from lost and the rest of the world is just getting started for this wonder drug.
Long and Strong!
And another updated FAQ
"Do Amarin’s commercial plans in the U.S. change as a result of the launch of a second generic version of icosapent ethyl (IPE) from what was described in previous quarterly communications? No. As background, we are aware that, as expected, a second generic version of IPE has become available. Based on Medi-Span, effective June 22, 2021 the wholesale price of the second generic version of IPE is priced at the same price as the first generic product ($301.86 for 120 count of 1 gram capsules – a 1 month supply). Both launched generics have limited indications (a.k.a. “skinny labels”). They are indicated only for the original indication of VASCEPA: lowering TG in patients with very high TG levels (>500 mg/dL). Patients for this indication represented approximately $40M of Amarin’s net revenue in the U.S. in 2020. As of June 22, 2021, we do not yet know the extent to which this second generic has built a bolus of supply prior to launch or the capacity to which they can maintain supply. Both generic companies have expressed in the past that they anticipate having limited supply. Market dynamics for payors and patients are likely to be unusual relating to these generic products. For example: • Payors, net of rebates will in many cases find the generic to be more expensive than the branded product • Patients, particularly those using the co-pay card, will in many cases find the generic to be more expensive than the branded product or the generic to not be covered by insurance • The generic is only in the U.S. • We don’t expect these generic companies to support any clinical research or medical education both of which are needed by society for improved patient care Amarin’s plans are unchanged. We continue to see a large market need for preventative cardiovascular care for which branded VASCEPA is the only labeled product. It is our aim to increase prescriptions of VASCEPA particularly as patients return for ordinary medical care beyond the worries of COVID-19. As we have expressed in the past, we will manage our spending to reflect market dynamics such as COVID-19 and generic supply but we are working to grow branded VASCEPA in the U.S. despite skinny-labeled generic competition. There are, of course, risks and uncertainties to such plan but with a large market need, broad product labeling, continued investment in high volume, high quality, cost-efficient supply, and a very capable commercial team, we believe that continued promotion of branded VASCEPA in this United States is best for patient care and Amarin’s shareholders. Further discussion of our plans has been provided in our quarterly investor updates (e.g. SEC filings, press releases and conference calls). Dated: June 22, 2021 "
If amarin wins infringement case, reddy and Hikma will both go away. That original indication is not worth the squeeze
Reddy Is making sure they dont false market the drug and repeat what Teva did
. Reddy’s Icosapent Ethyl Capsules, 1 gram is approved for the following indication: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Please note that Dr. Reddy’s Icosapent Ethyl Capsules is not approved for the following indication: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
If you like AMRN buy the shares not the calls. They manipulate the calls to take your money. Once inv stop buying their call options they will take AMRN stock price higher .
Shares NOT calls
Guys relax. Unless this patent situation spills over into other indications and or Europe we’ve seen the worst of it. Could get a little worse, but there are not many companies that sell 600 million from one drug in US.
Find me small cap pharma company with a drug that brings in this much revenue
What are the path forward for Amarin?
1. Apparently we are only supposed to lose the 10% of the U.S market. Unfortunately, no one believes that. Anyway, script numbers need to reach 100K a week immediately without increasing the overhead. I am not sure how would they do this.
2. Merge with another small/mid cap bio firm which has a product approved already so that they can use the existing sales folks to sell multiple products.
3. Partner with a BP in the U.S and GIA rest of the world until a buyout materialize.
What other avenues are left that I missed? I would prefer AMRN to increase the sales but they had shown many times that they are not capable. Also, I do not like this CEO change transition taking long. I hope Karim would not become another JT after shadowing him for so long. I hope he has a concrete plan and reveal that on day one and lay a path to get there.
Hey Thomas, what stocks are you playing with these days? Please do share if you think of some stocks that can help to recuperate the losses here. Unfortunately, all the stocks that had been bottomed out last year has gained it back.
Amarin needs a partner. I am baffled at how they launched so effectively with Kowa (private Japanese firm...huge) with 310 US reps for five years so effectively calling on cardiologists and PCPs, getting the name out a L ong with increasing scripts and writers. Now they advertise on Fox, CBS, NBC, etc while the writing audience is working, grabbing dinner, or analyzing the days charts and data. Joe Sixpack and Jane Jelly Donut are NOT their audience. Can't comprehend the lack of a seasoned partner as a prelude to takeover or BO. Geeeeeez
Folks remember when we were upset with $6.66 per share? I swallowed really hard and sold 6K shares out of my 12K. I refuse to calculate the capitalized loss today but it is mind numbing for me and will simply mess up rest of my work day to do so. I had so much money tied down here, the sob story never seems to end and the continuing tax on my confidence is no longer worth it. I'm sorry to have to keep looing at other 6K lot for a while longer..
I for one am glad this story is over for the US market. Time to focus in 100% on the ex-US market, and launch with precision in Europe. AMRN still has the potential to be a $20-$30 stock without the US market. This is a long play. The ex-US market hasn’t changed, the product hasn’t changed, and the CVD benefits haven’t changed. The rest of the world will benefit from Vascepa and the stock will respond accordingly. More patience needed. Long AMRN.
Breaking News: Here's why Buy-Out timeline, Stockvadar-reports, just became Imminent
With the SCOTUS variable removed, with the EU approved, and with the US clarified, the BO is no longer impeded by a lingering SCOTUS variable. And while, Amarin's ultimate valuation might slip a few billion due to the SCOTUS decision, nothing is keeping Amarin and its suitor from pulling the trigger.
What Karim is now doing is a pure clean-up, dust-up of the company. Meanwhile the BP buying Amarin will handily address the generics in court for infringement, and immediately integrate Vascepa/Vazkepa into their own sales strategy. Effective today, 99% of the US/EU sales force will be looking for a job.
The only other meaningful variable(s) is if Vascepa has a marketable use in other indications (e.g. Covid), but this has very little influence on the BO.
August/September is our new target date. It could however happen sooner. BTW, look up sales staff qualifications: it's down to 1 yr pharma sales experience (Hint" Newbies easy to fire). Karim has been commissioned by the BP to create the upper level infrastructure to oversee/manage the transition.
We are sorry SCOTUS cost us a few billion, but in the final analysis, it has totally moved up the BO.
Maybe now Amarin will do the obvious thing and declare its own generic! That would add $1-2 per share.
AMRN should move on they have the EU for the next 10 years nothing changed. just i am using the big drop today to average down .now we know the court battle its over lets concentrate on the core business that is good 👍
this time next year this company share will be in double digit
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